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2. Long-term outcomes of the global tuberculosis and COVID-19 co-infection cohort.

Author

Casco N, Jorge AL, Palmero DJ, Alffenaar JW, Fox GJ, Ezz W, Cho JG, Denholm J, Skrahina A, Solodovnikova V, Arbex MA, Alves T, Rabahi MF, Pereira GR, Sales R, Silva DR, Saffie MM, Salinas NE, Miranda RC, Cisterna C, Concha C, Fernandez I, Villalón C, Vera CG, Tapia PG, Cancino V, Carbonell M, Cruz A, Muñoz E, Muñoz C, Navarro I, Pizarro R, Cristina Sánchez GP, Vergara Riquelme MS, Vilca E, Soto A, Flores X, Garavagno A, Bahamondes MH, Merino LM, Pradenas AM, Revillot ME, Rodriguez P, Salinas AS, Taiba C, Valdés JF, Subiabre JN, Ortega C, Palma S, Castillo PP, Pinto M, Bidegain FR, Venegas M, Yucra E, Li Y, Cruz A, Guelvez B, Victoria Plaza R, Tello Hoyos KY, Cardoso-Landivar J, Van Den Boom M, Andréjak C, Blanc FX, Dourmane S, Froissart A, Izadifar A, Rivière F, Schlemmer F, Manika K, Diallo BD, Hassane-Harouna S, Artiles N, Mejia LA, Gupta N, Ish P, Mishra G, Patel JM, Singla R, Udwadia ZF, Alladio F, Angeli F, Calcagno A, Centis R, Codecasa LR, De Lauretis A, Esposito SMR, Formenti B, Gaviraghi A, Giacomet V, Goletti D, Gualano G, Matteelli A, Migliori GB, Motta I, Palmieri F, Pontali E, Prestileo T, Riccardi N, Saderi L, Saporiti M, Sotgiu G, Spanevello A, Stochino C, Tadolini M, Torre A, Villa S, Visca D, Kurhasani X, Furjani M, Rasheed N, Danila E, Diktanas S, Ridaura RL, Luna López FL, Torrico MM, Rendon A, Akkerman OW, Chizaram O, Al-Abri S, Alyaquobi F, Althohli K, Aguirre S, Teixeira RC, De Egea V, Irala S, Medina A, Sequera G, Sosa N, Vázquez F, Llanos-Tejada FK, Manga S, Villanueva-Villegas R, Araujo D, Sales Marques RD, Socaci A, Barkanova O, Bogorodskaya M, Borisov S, Mariandyshev A, Kaluzhenina A, Vukicevic TA, Stosic M, Beh D, Ng D, Ong CWM, Solovic I, Dheda K, Gina P, Caminero JA, De Souza Galvão ML, Dominguez-Castellano A, García-García JM, Pinargote IM, Fernandez SQ, Sánchez-Montalvá A, Huguet ET, Murguiondo MZ, Bart PA, Mazza-Stalder J, D'Ambrosio L, Kamolwat P, Bakko F, Barnacle J, Bird S, Brown A, Chandran S, Killington K, Man K, Papineni P, Ritchie F, Tiberi S, Utjesanovic N, Zenner D, Hearn JL, Heysell S, and Young L

Subjects
Humans, Male, Risk Factors, Retrospective Studies, COVID-19 complications, HIV Infections complications, Coinfection, Tuberculosis, Miliary
Abstract

Background: Longitudinal cohort data of patients with tuberculosis (TB) and coronavirus disease 2019 (COVID-19) are lacking. In our global study, we describe long-term outcomes of patients affected by TB and COVID-19., Methods: We collected data from 174 centres in 31 countries on all patients affected by COVID-19 and TB between 1 March 2020 and 30 September 2022. Patients were followed-up until cure, death or end of cohort time. All patients had TB and COVID-19; for analysis purposes, deaths were attributed to TB, COVID-19 or both. Survival analysis was performed using Cox proportional risk-regression models, and the log-rank test was used to compare survival and mortality attributed to TB, COVID-19 or both., Results: Overall, 788 patients with COVID-19 and TB (active or sequelae) were recruited from 31 countries, and 10.8% (n=85) died during the observation period. Survival was significantly lower among patients whose death was attributed to TB and COVID-19 versus those dying because of either TB or COVID-19 alone (p<0.001). Significant adjusted risk factors for TB mortality were higher age (hazard ratio (HR) 1.05, 95% CI 1.03-1.07), HIV infection (HR 2.29, 95% CI 1.02-5.16) and invasive ventilation (HR 4.28, 95% CI 2.34-7.83). For COVID-19 mortality, the adjusted risks were higher age (HR 1.03, 95% CI 1.02-1.04), male sex (HR 2.21, 95% CI 1.24-3.91), oxygen requirement (HR 7.93, 95% CI 3.44-18.26) and invasive ventilation (HR 2.19, 95% CI 1.36-3.53)., Conclusions: In our global cohort, death was the outcome in >10% of patients with TB and COVID-19. A range of demographic and clinical predictors are associated with adverse outcomes., Competing Interests: Conflict of interest: The authors have no potential conflicts of interest to disclose., (Copyright ©The authors 2023.)

Published
2023
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3. Eradication of Burkholderia cepacia complex in cystic fibrosis patients with inhalation of amiloride and tobramycin combined with oral cotrimoxazole.

Author

Akkerman-Nijland AM, Rottier BL, Holstein J, Winter RLJ, Touw DJ, Akkerman OW, and Koppelman GH

Abstract

This case series suggests that successful eradication therapy of BCC in cystic fibrosis can be done with a combination of inhaled and oral medication, which in many cases may eliminate the need for intensive treatment with intravenous antibiotics https://bit.ly/40oOMIn., Competing Interests: Conflict of interest: A.M. Akkerman-Nijland has nothing to declare. Conflict of interest: B.L. Rottier has nothing to declare. Conflict of interest: J. Holstein has nothing to declare. Conflict of interest: R.L.J. Winter has nothing to declare. Conflict of interest: D.J. Touw reports a grant from Chiesi Pharmaceuticals, and participated in an advisory board for SANQUIN, Pure IMS and the FORMAT trial, outside the submitted work. Conflict of interest: O.W. Akkerman has nothing to declare. Conflict of interest: G.H. Koppelman reports grants from Lung Foundation of the Netherlands, TEVA the Netherlands, VERTEX, GSK, Ubbo Emmius Foundation and TETRI foundation, outside the submitted work; and participated in advisory boards for PURE-IMS, AstraZeneca and GSK, outside the submitted work., (Copyright ©The authors 2023.)

Published
2023
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4. Combining digital adherence technology and therapeutic drug monitoring for personalised tuberculosis care.

Author

Ghimire S, Iskandar D, van der Borg-Boekhout R, Zenina M, Bolhuis MS, Kerstjens HAM, van Rossum M, Touw DJ, Zijp TR, van Boven JFM, and Akkerman OW

Subjects
Humans, Antitubercular Agents therapeutic use, Technology, Medication Adherence, Drug Monitoring, Tuberculosis drug therapy
Abstract

Competing Interests: Conflict of interest: All authors report that smart pill bottles were provided free of charge by Pill Connect/eLucid mHealth, along with grant payments (made to institution) supporting the present work. D.J. Touw reports grants from Chiesi Pharmaceuticals; consulting fees from PureIMS; lecture honoraria from PAO Farmacie; participation on a data safety monitoring board for the FORMAT trial; and participation on an advisory board for Sanquin, outside the submitted work. M.S. Bolhuis reports consulting fees from Pfizer and Kinderformularium, Pediatric formulary Netherlands; lecture honoraria from PAO Farmacie; outside the submitted work. All other authors have nothing else to disclose.

Published
2022
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5. Towards elimination of childhood and adolescent tuberculosis in the Netherlands: an epidemiological time-series analysis of national surveillance data.

Author

Gafar F, Ochi T, Van't Boveneind-Vrubleuskaya N, Akkerman OW, Erkens C, van den Hof S, van der Werf TS, Alffenaar JC, and Wilffert B

Subjects
Adolescent, Africa epidemiology, Child, Disease Notification, Humans, Incidence, Netherlands epidemiology, Population Surveillance, Retrospective Studies, Emigrants and Immigrants, Tuberculosis epidemiology, Tuberculosis prevention & control
Abstract

Background: Tuberculosis (TB) in children and adolescents is a sentinel event for ongoing transmission. In the Netherlands, epidemiological characteristics of childhood and adolescent TB have not been fully evaluated. Therefore, we aimed to assess TB epidemiology within this population to provide guidance for TB elimination., Methods: A retrospective time-series analysis using national surveillance data from 1993-2018 was performed in children (aged <15 years) and adolescents (aged 15-19 years) with TB. Poisson regression models offset with log-population size were used to estimate notification rates and rate ratios. Trends in notification rates were estimated using average annual percentage changes (AAPC) based on the segmented linear regression analysis., Results: Among 3899 children and adolescents with TB notified during 1993-2018, 2418 (62%) were foreign-born (725 (41.3%) out of 1755 children and 1693 (78.9%) out of 2144 adolescents). The overall notification rate in children was 2.3 per 100 000 person-years, declining steadily during the study period (AAPC -10.9%, 95% CI -12.6--9.1). In adolescents, the overall notification rate was 8.4 per 100 000 person-years, strongly increasing during 1993-2001 and 2012-2018. Compared to Dutch-born children and adolescents, substantially higher notification rates were observed among African-born children and adolescents (116.8 and 316.6 per 100 000 person-years, respectively). Additionally, an increasing trend was observed in African-born adolescents (AAPC 18.5%, 95% CI 11.9-25.5). Among the foreign-born population, those from countries in the horn of Africa contributed most to the TB caseload., Conclusion: TB notification rate among children was low and constantly declining across different demographic groups. However, heterogeneities were shown in adolescents, with an increasing trend in the foreign-born, particularly those from Africa., Competing Interests: Conflict of interest: F. Gafar has nothing to disclose. Conflict of interest: T. Ochi is an employee of BaseClear B.V. (commercial, non-R&D). Conflict of interest: N. van't Boveneind-Vrubleuskaya has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: C. Erkens has nothing to disclose. Conflict of interest: S. van den Hof has nothing to disclose. Conflict of interest: T.S. van der Werf has nothing to disclose. Conflict of interest: J-W.C. Alffenaar has nothing to disclose. Conflict of interest: B. Wilffert has nothing to disclose., (Copyright ©ERS 2020.)

Published
2020
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6. Dose optimisation of first-line tuberculosis drugs using therapeutic drug monitoring in saliva: feasible for rifampicin, not for isoniazid.

Author

van den Elsen SHJ, Akkerman OW, Wessels M, Jongedijk EM, Ghimire S, van der Werf TS, Bolhuis MS, Touw DJ, and Alffenaar JC

Subjects
Antitubercular Agents therapeutic use, Drug Monitoring, Humans, Isoniazid, Rifampin, Saliva, Mycobacterium tuberculosis, Pharmaceutical Preparations, Tuberculosis drug therapy
Abstract

Competing Interests: Conflict of interest: S.H.J. van den Elsen has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: M. Wessels has nothing to disclose. Conflict of interest: E.M. Jongedijk has nothing to disclose. Conflict of interest: S. Ghimire has nothing to disclose. Conflict of interest: T.S. van der Werf has nothing to disclose. Conflict of interest: M.S. Bolhuis has nothing to disclose. Conflict of interest: D.J. Touw has nothing to disclose. Conflict of interest: J-W.C. Alffenaar has nothing to disclose.

Published
2020
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7. Therapeutic drug monitoring using saliva as matrix: an opportunity for linezolid, but challenge for moxifloxacin.

Author

van den Elsen SHJ, Akkerman OW, Jongedijk EM, Wessels M, Ghimire S, van der Werf TS, Touw DJ, Bolhuis MS, and Alffenaar JC

Subjects
Adult, Antitubercular Agents blood, Antitubercular Agents pharmacokinetics, Female, Humans, Linezolid pharmacokinetics, Male, Microbial Sensitivity Tests, Middle Aged, Moxifloxacin pharmacokinetics, Netherlands, Prospective Studies, Drug Monitoring methods, Linezolid blood, Moxifloxacin blood, Saliva metabolism, Tuberculosis, Multidrug-Resistant drug therapy
Abstract

Competing Interests: Conflict of interest: S.H.J. van den Elsen has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: E.M. Jongedijk has nothing to disclose. Conflict of interest: M. Wessels has nothing to disclose. Conflict of interest: S. Ghimire has nothing to disclose. Conflict of interest: T.S. van der Werf has nothing to disclose. Conflict of interest: D.J. Touw has nothing to disclose. Conflict of interest: M.S. Bolhuis has nothing to disclose. Conflict of interest: J-W.C. Alffenaar has nothing to disclose.

Published
2020
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8. Should we worry about bedaquiline exposure in the treatment of multidrug-resistant and extensively drug-resistant tuberculosis?

Author

Alffenaar JC, Akkerman OW, Tiberi S, Sotgiu G, and Migliori GB

Subjects
Antitubercular Agents therapeutic use, Diarylquinolines, Humans, Extensively Drug-Resistant Tuberculosis drug therapy, Tuberculosis, Multidrug-Resistant drug therapy
Abstract

Competing Interests: Conflict of interest: J-W.C. Alffenaar has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: S. Tiberi has nothing to disclose. Conflict of interest: G. Sotgiu has nothing to disclose. Conflict of interest: G.B. Migliori has nothing to disclose.

Published
2020
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9. Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report.

Author

Borisov S, Danila E, Maryandyshev A, Dalcolmo M, Miliauskas S, Kuksa L, Manga S, Skrahina A, Diktanas S, Codecasa LR, Aleksa A, Bruchfeld J, Koleva A, Piubello A, Udwadia ZF, Akkerman OW, Belilovski E, Bernal E, Boeree MJ, Cadiñanos Loidi J, Cai Q, Cebrian Gallardo JJ, Dara M, Davidavičienė E, Forsman LD, De Los Rios J, Denholm J, Drakšienė J, Duarte R, Elamin SE, Escobar Salinas N, Ferrarese M, Filippov A, Garcia A, García-García JM, Gaudiesiute I, Gavazova B, Gayoso R, Gomez Rosso R, Gruslys V, Gualano G, Hoefsloot W, Jonsson J, Khimova E, Kunst H, Laniado-Laborín R, Li Y, Magis-Escurra C, Manfrin V, Marchese V, Martínez Robles E, Matteelli A, Mazza-Stalder J, Moschos C, Muñoz-Torrico M, Mustafa Hamdan H, Nakčerienė B, Nicod L, Nieto Marcos M, Palmero DJ, Palmieri F, Papavasileiou A, Payen MC, Pontarelli A, Quirós S, Rendon A, Saderi L, Šmite A, Solovic I, Souleymane MB, Tadolini M, van den Boom M, Vescovo M, Viggiani P, Yedilbayev A, Zablockis R, Zhurkin D, Zignol M, Visca D, Spanevello A, Caminero JA, Alffenaar JW, Tiberi S, Centis R, D'Ambrosio L, Pontali E, Sotgiu G, and Migliori GB

Subjects
Adult, Aged, Female, Humans, Male, Middle Aged, Pharmacovigilance, Prospective Studies, Antitubercular Agents adverse effects, Drug-Related Side Effects and Adverse Reactions diagnosis, Drug-Related Side Effects and Adverse Reactions epidemiology, Tuberculosis, Multidrug-Resistant drug therapy
Abstract

The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new ( i.e. bedaquiline, delamanid) and repurposed ( i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1-2) and 57 (11.3%) as serious (grade 3-5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care., Competing Interests: Conflict of interest: S. Borisov has nothing to disclose. Conflict of interest: E. Danila has nothing to disclose. Conflict of interest: A. Maryandyshev has nothing to disclose. Conflict of interest: M. Dalcolmo has nothing to disclose. Conflict of interest: S. Miliauskas has nothing to disclose. Conflict of interest: L. Kuksa reports personal fees for trial participation from Otsuka and Tibotec, personal fees for lectures from Johnson and Johnson Services Inc., outside the submitted work. Conflict of interest: S. Manga has nothing to disclose. Conflict of interest: A. Skrahina has nothing to disclose. Conflict of interest: S. Diktanas reports personal fees for trial participation from Otsuka, grants for meeting attendance from Janssen (Sirturo), outside the submitted work. Conflict of interest: L.R. Codecasa has nothing to disclose. Conflict of interest: A. Aleksa has nothing to disclose. Conflict of interest: J. Bruchfeld has nothing to disclose. Conflict of interest: A. Koleva has nothing to disclose. Conflict of interest: A. Piubello has nothing to disclose. Conflict of interest: Z.F. Udwadia has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: E. Belilovski has nothing to disclose. Conflict of interest: E. Bernal has nothing to disclose. Conflict of interest: M.J. Boeree has nothing to disclose. Conflict of interest: J. Cadiñanos Loidi has nothing to disclose. Conflict of interest: Q. Cai has nothing to disclose. Conflict of interest: J.J. Cebrian Gallardo has nothing to disclose. Conflict of interest: M. Dara has nothing to disclose. Conflict of interest: E. Davidavičienė has nothing to disclose. Conflict of interest: L. Davies Forsman has nothing to disclose. Conflict of interest: J. De Los Rios has nothing to disclose. Conflict of interest: J. Denholm has nothing to disclose. Conflict of interest: J. Drakšienė has nothing to disclose. Conflict of interest: R. Duarte has nothing to disclose. Conflict of interest: S.E. Elamin has nothing to disclose. Conflict of interest: N. Escobar Salinas has nothing to disclose. Conflict of interest: M. Ferrarese has nothing to disclose. Conflict of interest: A. Filippov has nothing to disclose. Conflict of interest: A. Garcia has nothing to disclose. Conflict of interest: J.M. García-García has nothing to disclose. Conflict of interest: I. Gaudiesiute has nothing to disclose. Conflict of interest: B. Gavazova has nothing to disclose. Conflict of interest: R. Gayoso has nothing to disclose. Conflict of interest: R. Gomez Rosso has nothing to disclose. Conflict of interest: V. Gruslys has nothing to disclose. Conflict of interest: G. Gualano has nothing to disclose. Conflict of interest: W. Hoefsloot has nothing to disclose. Conflict of interest: J. Jonsson has nothing to disclose. Conflict of interest: E. Khimova has nothing to disclose. Conflict of interest: H. Kunst has nothing to disclose. Conflict of interest: R. Laniado-Laborín has nothing to disclose. Conflict of interest: Y. Li has nothing to disclose. Conflict of interest: C. Magis-Escurra has nothing to disclose. Conflict of interest: V. Manfrin has nothing to disclose. Conflict of interest: V. Marchese has nothing to disclose. Conflict of interest: E. Martínez Robles has nothing to disclose. Conflict of interest: A. Matteelli has nothing to disclose. Conflict of interest: J. Mazza-Stalder has nothing to disclose. Conflict of interest: C. Moschos has nothing to disclose. Conflict of interest: M. Muñoz-Torrico has nothing to disclose. Conflict of interest: H. Mustafa Hamdan has nothing to disclose. Conflict of interest: B. Nakčerienė has nothing to disclose. Conflict of interest: L. Nicod has nothing to disclose. Conflict of interest: M. Nieto Marcos has nothing to disclose. Conflict of interest: D.J. Palmero has nothing to disclose. Conflict of interest: F. Palmieri has nothing to disclose. Conflict of interest: A. Papavasileiou has nothing to disclose. Conflict of interest: M-C. Payen has nothing to disclose. Conflict of interest: A. Pontarelli has nothing to disclose. Conflict of interest: S. Quirós has nothing to disclose. Conflict of interest: A. Rendon has nothing to disclose. Conflict of interest: L. Saderi has nothing to disclose. Conflict of interest: A. Šmite has nothing to disclose. Conflict of interest: I. Solovic has nothing to disclose. Conflict of interest: M.B. Souleymane has nothing to disclose. Conflict of interest: M. Tadolini has nothing to disclose. Conflict of interest: M. van den Boom has nothing to disclose. Conflict of interest: M. Vescovo has nothing to disclose. Conflict of interest: P. Viggiani has nothing to disclose. Conflict of interest: A. Yedilbayev has nothing to disclose. Conflict of interest: R. Zablockis has nothing to disclose. Conflict of interest: D. Zhurkin has nothing to disclose. Conflict of interest: M. Zignol has nothing to disclose. Conflict of interest: D. Visca has nothing to disclose. Conflict of interest: A. Spanevello has nothing to disclose. Conflict of interest: J.A. Caminero has nothing to disclose. Conflict of interest: J-W. Alffenaar has nothing to disclose. Conflict of interest: S. Tiberi has nothing to disclose. Conflict of interest: R. Centis has nothing to disclose. Conflict of interest: L. D'Ambrosio has nothing to disclose. Conflict of interest: E. Pontali has nothing to disclose. Conflict of interest: G. Sotgiu has nothing to disclose. Conflict of interest: G.B. Migliori has nothing to disclose., (Copyright ©ERS 2019.)

Published
2019
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10. Nationwide analysis of treatment outcomes in children and adolescents routinely treated for tuberculosis in the Netherlands.

Author

Gafar F, Van't Boveneind-Vrubleuskaya N, Akkerman OW, Wilffert B, and Alffenaar JC

Subjects
Adolescent, Antitubercular Agents adverse effects, Child, Child, Preschool, Coinfection epidemiology, Female, HIV Infections epidemiology, Humans, Incidence, Infant, Infant, Newborn, Logistic Models, Lost to Follow-Up, Male, Netherlands epidemiology, Registries, Retrospective Studies, Risk Factors, Treatment Outcome, Tuberculosis mortality, Tuberculosis, Multidrug-Resistant epidemiology, Antitubercular Agents therapeutic use, Tuberculosis drug therapy, Tuberculosis epidemiology
Abstract

Background: As a vulnerable population, children and adolescents with tuberculosis (TB) are faced with many challenges, even those who live in low TB incidence countries. We aimed to evaluate factors associated with TB treatment outcomes allowing more focused interventions to support this population once diagnosed., Methods: A retrospective cohort study using a nationwide surveillance database was performed in children and adolescents (aged 0-18 years) treated for TB in the Netherlands from 1993 to 2018. Logistic regression analyses were used to estimate adjusted odds ratios (aOR) for associated factors of mortality and loss to follow-up (LTFU)., Results: Among 3253 eligible patients with known outcomes, 94.4% (95.9% children and 92.8% adolescents) were cured or completed treatment, 0.7% died during treatment and 4.9% were LTFU. There were no reported treatment failures. Risk factors of death included children aged 2-4 years (aOR 10.42), central nervous system TB (aOR 5.14), miliary TB (aOR 10.25), HIV co-infection (aOR 8.60), re-treated TB cases (aOR 10.12) and drug-induced liver injury (aOR 6.50). Active case-finding was a protective factor of death (aOR 0.13). Risk factors of LTFU were adolescents aged 15-18 years (aOR 1.91), illegal immigrants (aOR 4.28), urban domicile (aOR 1.59), unknown history of TB contact (aOR 1.99), drug-resistant TB (aOR 2.31), single adverse drug reaction (aOR 2.12), multiple adverse drug reactions (aOR 7.84) and treatment interruption >14 days (aOR 6.93). Treatment in recent years (aOR 0.94) and supervision by public health nurses (aOR 0.14) were protective factors of LTFU., Conclusion: Highly successful treatment outcomes were demonstrated in children and adolescents routinely treated for TB. Special attention should be given to specific risk groups to improve treatment outcomes., Competing Interests: Conflict of interest: F. Gafar has nothing to disclose. Conflict of interest: N. van't Boveneind-Vrubleuskaya has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: B. Wilffert has nothing to disclose. Conflict of interest: J-W.C. Alffenaar has nothing to disclose., (Copyright ©ERS 2019.)

Published
2019
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11. Treatment of multidrug-resistant tuberculosis using therapeutic drug monitoring: first experiences with sub-300 mg linezolid dosages using in-house made capsules.

Author

Bolhuis MS, van der Werf TS, Kerstjens HAM, de Lange WCM, Alffenaar JC, and Akkerman OW

Subjects
Adolescent, Adult, Antitubercular Agents administration & dosage, Antitubercular Agents pharmacokinetics, Capsules, Female, Humans, Male, Middle Aged, Retrospective Studies, Young Adult, Drug Monitoring, Linezolid administration & dosage, Linezolid pharmacokinetics, Tuberculosis, Multidrug-Resistant drug therapy
Abstract

Competing Interests: Conflict of interest: M.S. Bolhuis has nothing to disclose. Conflict of interest: T.S. van der Werf has nothing to disclose. Conflict of interest: H.A.M. Kerstjens has nothing to disclose. Conflict of interest: W.C.M. de Lange has nothing to disclose. Conflict of interest: J-W.C. Alffenaar has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose.

Published
2019
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12. Impact of radiographic screening of >34 000 asylum seeker children.

Author

Wolters BA, Akkerman OW, Aartsma Y, de Lange WCM, Schölvinck EH, van der Werf TS, and van Hest R

Subjects
Adolescent, Child, Child, Preschool, Communicable Disease Control, Europe, Human Migration, Humans, Infant, Infant, Newborn, Netherlands, Tuberculosis epidemiology, Tuberculosis prevention & control, Mass Screening methods, Refugees, Tuberculosis diagnostic imaging
Abstract

Competing Interests: Conflict of interest: B.A. Wolters has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose. Conflict of interest: Y. Aartsma has nothing to disclose. Conflict of interest: W.C.M. de Lange has nothing to disclose. Conflict of interest: E.H. Schölvinck has nothing to disclose. Conflict of interest: T.S. van der Werf has nothing to disclose. Conflict of interest: R. Van Hest has nothing to disclose.

Published
2019
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13. Reduced moxifloxacin exposure in patients with tuberculosis and diabetes.

Author

Dekkers BGJ, Bolhuis MS, Ter Beek L, de Lange WCM, van der Werf TS, Alffenaar JC, and Akkerman OW

Subjects
Adult, Comorbidity, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Antitubercular Agents administration & dosage, Diabetes Mellitus, Moxifloxacin administration & dosage, Tuberculosis drug therapy
Abstract

Competing Interests: Conflict of interest: B.G.J. Dekkers has nothing to disclose. Conflict of interest: M.S. Bolhuis has nothing to disclose. Conflict of interest: L. ter Beek has nothing to disclose. Conflict of interest: W.C.M. de Lange has nothing to disclose. Conflict of interest: T.S. van der Werf has nothing to disclose. Conflict of interest: J-W.C. Alffenaar has nothing to disclose. Conflict of interest: O.W. Akkerman has nothing to disclose.

Published
2019
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14. Cross border, highly individualised treatment of a patient with challenging extensively drug-resistant tuberculosis.

Author

Akkerman OW, Grasmeijer F, de Lange WCM, Kerstjens HAM, de Vries G, Bolhuis MS, Alffenaar JW, Frijlink HW, Smith G, Gajraj R, de Zwaan R, Hagedoorn P, Dedicoat M, van Soolingen D, and van der Werf TS

Subjects
Adult, Antitubercular Agents therapeutic use, Colistin administration & dosage, Diarylquinolines administration & dosage, Drug Synergism, Humans, Isoniazid administration & dosage, Male, Medication Adherence, Mycobacterium tuberculosis, Netherlands, Nitroimidazoles administration & dosage, Oxazoles administration & dosage, Patient Isolation, Phenotype, Trimethoprim, Sulfamethoxazole Drug Combination administration & dosage, United Kingdom, Extensively Drug-Resistant Tuberculosis drug therapy, Extensively Drug-Resistant Tuberculosis transmission
Abstract

Competing Interests: Conflict of interest: F. Grasmeijer reports part time employment by PureIMS BV, outside the submitted work. Conflict of interest: H.W. Frijlink has a patent for a breath actuated dry powder inhaler (number WO 2015/187025 A1) pending. Conflict of interest: P. Hagedoorn has a patent pending and is co-inventor of Twincer. Conflict of interest: T.S. van der Werf was principal investigator of the RUTI therapeutic vaccine trial, sponsored in part by Archivel, Badelona, Spain; and participated in a meeting organised and sponsored by TBVI in June, 2016, and in a meeting organised by TBVI and sponsored by Transgene−Institut Merieux France, in November 2017.

Published
2018
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15. Lack of penetration of amikacin into saliva of tuberculosis patients.

Author

van den Elsen SHJ, Akkerman OW, Huisman JR, Touw DJ, van der Werf TS, Bolhuis MS, and Alffenaar JC

Subjects
Adult, Aminoglycosides metabolism, Drug Monitoring methods, Female, Humans, Immunoassay methods, Male, Middle Aged, Prospective Studies, Saliva metabolism, Treatment Outcome, Amikacin pharmacokinetics, Saliva drug effects, Tuberculosis drug therapy
Abstract

Competing Interests: Conflict of interest: None declared.

Published
2018
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16. Pharmacokinetics of moxifloxacin and linezolid during and after pregnancy in a patient with multidrug-resistant tuberculosis.

Author

Van Kampenhout E, Bolhuis MS, Alffenaar JC, Oswald LM, Kerstjens HA, de Lange WC, van der Werf TS, and Akkerman OW

Subjects
Adult, Antitubercular Agents pharmacokinetics, Antitubercular Agents therapeutic use, Female, Humans, Moxifloxacin, Mycobacterium tuberculosis isolation & purification, Pregnancy, Fluoroquinolones pharmacokinetics, Fluoroquinolones therapeutic use, Linezolid pharmacokinetics, Linezolid therapeutic use, Tuberculosis, Multidrug-Resistant drug therapy
Published
2017
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17. Safety and tolerability of clarithromycin in the treatment of multidrug-resistant tuberculosis.

Author

Van der Paardt AL, Akkerman OW, Gualano G, Palmieri F, Davies Forsman L, Aleksa A, Tiberi S, de Lange WC, Bolhuis MS, Skrahina A, van Soolingen D, Kosterink JG, Migliori GB, van der Werf TS, and Alffenaar JC

Subjects
Adult, Antitubercular Agents adverse effects, Clarithromycin adverse effects, Female, Humans, Male, Middle Aged, Mycobacterium tuberculosis isolation & purification, Recurrence, Sputum microbiology, Antitubercular Agents administration & dosage, Clarithromycin administration & dosage, Tuberculosis, Multidrug-Resistant drug therapy
Published
2017
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18. Shorter treatment for multidrug-resistant tuberculosis: the good, the bad and the ugly.

Author

van Altena R, Akkerman OW, Alffenaar JC, Kerstjens HA, Magis-Escurra C, Boeree MJ, van Soolingen D, de Lange WC, Bolhuis MS, Hoefsloot W, de Vries G, and van der Werf TS

Subjects
Humans, Netherlands, Practice Guidelines as Topic, Retrospective Studies, Treatment Outcome, Antitubercular Agents administration & dosage, Tuberculosis, Multidrug-Resistant drug therapy
Published
2016
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20. Dosage of isoniazid and rifampicin poorly predicts drug exposure in tuberculosis patients.

Author

Sturkenboom MG, Akkerman OW, van Altena R, de Lange WC, Kosterink JG, van der Werf TS, and Alffenaar JC

Subjects
Antitubercular Agents pharmacokinetics, Area Under Curve, Body Weight, Dose-Response Relationship, Drug, Drug Monitoring, Humans, Isoniazid pharmacokinetics, Rifampin pharmacokinetics, Antitubercular Agents administration & dosage, Isoniazid administration & dosage, Rifampin administration & dosage, Tuberculosis drug therapy
Published
2016
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21. Dried blood spots can help decrease the burden on patients dually infected with multidrug-resistant tuberculosis and HIV.

Author

Zuur MA, Akkerman OW, Touw DJ, van der Werf TS, Cobelens F, Burger DM, Grobusch MP, and Alffenaar JW

Subjects
Coinfection, HIV Infections blood, HIV Infections complications, Humans, Tuberculosis, Multidrug-Resistant blood, Tuberculosis, Multidrug-Resistant complications, Anti-Retroviral Agents therapeutic use, Antitubercular Agents therapeutic use, Dried Blood Spot Testing, Drug Monitoring, HIV Infections drug therapy, Tuberculosis, Multidrug-Resistant drug therapy
Published
2016
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22. Implementing tuberculosis entry screening for asylum seekers: the Groningen experience.

Author

Akkerman OW, de Lange WC, Schölvinck EH, Wolters B, Aartsma Y, van der Werf TS, and van Hest R

Subjects
Adult, Female, Humans, Male, Models, Organizational, Netherlands epidemiology, Outcome and Process Assessment, Health Care, Communicable Disease Control methods, Communicable Disease Control organization & administration, Mass Screening methods, Mass Screening organization & administration, Refugees statistics & numerical data, Tuberculosis diagnosis, Tuberculosis epidemiology, Tuberculosis prevention & control, Tuberculosis transmission
Published
2016
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23. Comparison of effectiveness and safety of imipenem/clavulanate- versus meropenem/clavulanate-containing regimens in the treatment of MDR- and XDR-TB.

Author

Tiberi S, Sotgiu G, D'Ambrosio L, Centis R, Abdo Arbex M, Alarcon Arrascue E, Alffenaar JW, Caminero JA, Gaga M, Gualano G, Skrahina A, Solovic I, Sulis G, Tadolini M, Alarcon Guizado V, De Lorenzo S, Roby Arias AJ, Scardigli A, Akkerman OW, Aleksa A, Artsukevich J, Auchynka V, Bonini EH, Chong Marín FA, Collahuazo López L, de Vries G, Dore S, Kunst H, Matteelli A, Moschos C, Palmieri F, Papavasileiou A, Payen MC, Piana A, Spanevello A, Vargas Vasquez D, Viggiani P, White V, Zumla A, and Migliori GB

Subjects
Adult, Cohort Studies, Comparative Effectiveness Research, Drug Resistance, Bacterial, Female, Humans, Male, Meropenem, Middle Aged, Sputum metabolism, Time Factors, Treatment Outcome, Antitubercular Agents administration & dosage, Clavulanic Acid administration & dosage, Extensively Drug-Resistant Tuberculosis drug therapy, Imipenem administration & dosage, Thienamycins administration & dosage, Tuberculosis, Multidrug-Resistant drug therapy
Abstract

No large study to date has ever evaluated the effectiveness, safety and tolerability of imipenem/clavulanate versus meropenem/clavulanate to treat multidrug- and extensively drug-resistant tuberculosis (MDR- and XDR-TB). The aim of this observational study was to compare the therapeutic contribution of imipenem/clavulanate versus meropenem/clavulanate added to background regimens to treat MDR- and XDR-TB cases.84 patients treated with imipenem/clavulanate-containing regimens showed a similar median number of antibiotic resistances (8 versus 8) but more fluoroquinolone resistance (79.0% versus 48.9%, p<0.0001) and higher XDR-TB prevalence (67.9% versus 49.0%, p=0.01) in comparison with 96 patients exposed to meropenem/clavulanate-containing regimens. Patients were treated with imipenem/clavulanate- and meropenem/clavulanate-containing regimens for a median (interquartile range) of 187 (60-428) versus 85 (49-156) days, respectively.Statistically significant differences were observed on sputum smear and culture conversion rates (79.7% versus 94.8%, p=0.02 and 71.9% versus 94.8%, p<0.0001, respectively) and on success rates (59.7% versus 77.5%, p=0.03). Adverse events to imipenem/clavulanate and meropenem/clavulanate were reported in 5.4% and 6.5% of cases only.Our study suggests that meropenem/clavulanate is more effective than imipenem/clavulanate in treating MDR/XDR-TB patients., (Copyright ©ERS 2016.)

Published
2016
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24. Incorporating therapeutic drug monitoring into the World Health Organization hierarchy of tuberculosis diagnostics.

Author

Ghimire S, Bolhuis MS, Sturkenboom MG, Akkerman OW, de Lange WC, van der Werf TS, and Alffenaar JW

Subjects
Humans, Medication Therapy Management organization & administration, Pharmacovigilance, World Health Organization, Antitubercular Agents administration & dosage, Antitubercular Agents adverse effects, Antitubercular Agents pharmacokinetics, Drug Monitoring methods, Tuberculosis diagnosis, Tuberculosis drug therapy
Published
2016
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25. Pharmacokinetics of ertapenem in patients with multidrug-resistant tuberculosis.

Author

van Rijn SP, van Altena R, Akkerman OW, van Soolingen D, van der Laan T, de Lange WC, Kosterink JG, van der Werf TS, and Alffenaar JW

Subjects
Adolescent, Adult, Aged, Area Under Curve, Ertapenem, Female, Humans, Male, Microbial Sensitivity Tests, Middle Aged, Mycobacterium tuberculosis, Netherlands, Retrospective Studies, Young Adult, Antitubercular Agents pharmacokinetics, Antitubercular Agents therapeutic use, Extensively Drug-Resistant Tuberculosis drug therapy, Tuberculosis, Multidrug-Resistant drug therapy, beta-Lactams pharmacokinetics, beta-Lactams therapeutic use
Abstract

Treatment of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) is becoming more challenging because of increased levels of drug resistance against second-line TB drugs. One promising group of antimicrobial drugs is carbapenems. Ertapenem is an attractive carbapenem for the treatment of MDR- and XDR-TB because its relatively long half-life enables once-daily dosing.A retrospective study was performed for all patients with suspected MDR-TB at the Tuberculosis Center Beatrixoord of the University Medical Center Groningen (Haren, the Netherlands) who received ertapenem as part of their treatment regimen between December 1, 2010 and March 1, 2013. Safety and pharmacokinetics were evaluated.18 patients were treated with 1000 mg ertapenem for a mean (range) of 77 (5-210) days. Sputum smear and culture were converted in all patients. Drug exposure was evaluated in 12 patients. The mean (range) area under the concentration-time curve up to 24 h was 544.9 (309-1130) h·mg·L(-1) The mean (range) maximum observed plasma concentration was 127.5 (73.9-277.9) mg·L(-1)In general, ertapenem treatment was well tolerated during MDR-TB treatment and showed a favourable pharmacokinetic/pharmacodynamic profile in MDR-TB patients. We conclude that ertapenem is a highly promising drug for the treatment of MDR-TB that warrants further investigation., (Copyright ©ERS 2016.)

Published
2016
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26. Effectiveness and safety of meropenem/clavulanate-containing regimens in the treatment of MDR- and XDR-TB.

Author

Tiberi S, Payen MC, Sotgiu G, D'Ambrosio L, Alarcon Guizado V, Alffenaar JW, Abdo Arbex M, Caminero JA, Centis R, De Lorenzo S, Gaga M, Gualano G, Roby Arias AJ, Scardigli A, Skrahina A, Solovic I, Sulis G, Tadolini M, Akkerman OW, Alarcon Arrascue E, Aleska A, Avchinko V, Bonini EH, Chong Marín FA, Collahuazo López L, de Vries G, Dore S, Kunst H, Matteelli A, Moschos C, Palmieri F, Papavasileiou A, Spanevello A, Vargas Vasquez D, Viggiani P, White V, Zumla A, and Migliori GB

Subjects
Adult, Female, Humans, Male, Meropenem, Retrospective Studies, Treatment Outcome, Antitubercular Agents administration & dosage, Clavulanic Acid administration & dosage, Extensively Drug-Resistant Tuberculosis drug therapy, Thienamycins administration & dosage, Tuberculosis, Multidrug-Resistant drug therapy
Abstract

No large study has ever evaluated the efficacy, safety and tolerability of meropenem/clavulanate to treat multidrug- and extensively drug-resistant tuberculosis (MDR- and XDR-TB). The aim of this observational study was to evaluate the therapeutic contribution, effectiveness, safety and tolerability profile of meropenem/clavulanate added to a background regimen when treating MDR- and XDR-TB cases.Patients treated with a meropenem/clavulanate-containing regimen (n=96) showed a greater drug resistance profile than those exposed to a meropenem/clavulanate-sparing regimen (n=168): in the former group XDR-TB was more frequent (49% versus 6.0%, p<0.0001) and the median (interquartile range (IQR)) number of antibiotic resistances was higher (8 (6-9)versus 5 (4-6)). Patients were treated with a meropenem/clavulanate-containing regimen for a median (IQR) of 85 (49-156) days.No statistically significant differences were observed in the overall MDR-TB cohort and in the subgroups with and without the XDR-TB patients; in particular, sputum smear and culture conversion rates were similar in XDR-TB patients exposed to meropenem/clavulanate-containing regimens (88.0% versus 100.0%, p=1.00 and 88.0% versus 100.0%, p=1.00, respectively). Only six cases reported adverse events attributable to meropenem/clavulanate (four of them then restarting treatment).The nondifferent outcomes and bacteriological conversion rate observed in cases who were more severe than controls might imply that meropenem/clavulanate could be active in treating MDR- and XDR-TB cases., (Copyright ©ERS 2016.)

Published
2016
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27. End TB with precision treatment!

Author

van der Burgt EP, Sturkenboom MG, Bolhuis MS, Akkerman OW, Kosterink JG, de Lange WC, Cobelens FG, van der Werf TS, and Alffenaar JW

Subjects
Female, Humans, Male, Antitubercular Agents administration & dosage, Communicable Disease Control organization & administration, Developed Countries, Global Health, Tuberculosis drug therapy, Tuberculosis prevention & control
Published
2016
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28. Evaluation of macrolides for possible use against multidrug-resistant Mycobacterium tuberculosis.

Author

van der Paardt AF, Wilffert B, Akkerman OW, de Lange WC, van Soolingen D, Sinha B, van der Werf TS, Kosterink JG, and Alffenaar JW

Subjects
Humans, Microbial Sensitivity Tests, Antitubercular Agents therapeutic use, Macrolides therapeutic use, Mycobacterium tuberculosis drug effects, Tuberculosis, Multidrug-Resistant drug therapy
Abstract

Multidrug-resistant tuberculosis (MDR-TB) is a major global health problem. The loss of susceptibility to an increasing number of drugs behoves us to consider the evaluation of non-traditional anti-tuberculosis drugs.Clarithromycin, a macrolide antibiotic, is defined as a group 5 anti-tuberculosis drug by the World Health Organization; however, its role or efficacy in the treatment of MDR-TB is unclear. A systematic review of the literature was conducted to summarise the evidence for the activity of macrolides against MDR-TB, by evaluating in vitro, in vivo and clinical studies. PubMed and Embase were searched for English language articles up to May 2014.Even though high minimum inhibitory concentration values are usually found, suggesting low activity against Mycobacterium tuberculosis, the potential benefits of macrolides are their accumulation in the relevant compartments and cells in the lungs, their immunomodulatory effects and their synergistic activity with other anti-TB drugs.A future perspective may be use of more potent macrolide analogues to enhance the activity of the treatment regimen., (Copyright ©ERS 2015.)

Published
2015
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30. Drug concentration in lung tissue in multidrug-resistant tuberculosis.

Author

Akkerman OW, van Altena R, Klinkenberg T, Brouwers AH, Bongaerts AH, van der Werf TS, and Alffenaar JW

Subjects
Adolescent, Female, Humans, Lung microbiology, Netherlands, Pneumonectomy, Radiography, Thoracic, Somalia, Tuberculosis, Multidrug-Resistant ethnology, Antitubercular Agents therapeutic use, Drug Monitoring, Lung drug effects, Tuberculosis, Multidrug-Resistant drug therapy, Tuberculosis, Multidrug-Resistant physiopathology
Published
2013
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