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1. Glucocorticoid dysfunction in children with severe malaria

Author

Leen Vandermosten, Fran Prenen, Balotin Fogang, Pauline Dagneau de Richecour, Sofie Knoops, Christiane Josiane Donkeu, Cathy Doric Piemba Nguefack, Jean-Voisin Taguebue, Paul Koki Ndombo, Bart Ghesquière, Lawrence Ayong, and Philippe E. Van den Steen

Subjects
malaria, glucocorticoids, plasmodium, metabolomics, cortisol, Immunologic diseases. Allergy, RC581-607
Abstract

IntroductionMalaria remains a widespread health problem with a huge burden. Severe or complicated malaria is highly lethal and encompasses a variety of pathological processes, including immune activation, inflammation, and dysmetabolism. Previously, we showed that adrenal hormones, in particular glucocorticoids (GCs), play critical roles to maintain disease tolerance during Plasmodium infection in mice. Here, GC responses were studied in Cameroon in children with uncomplicated malaria (UM), severe malaria (SM) and asymptomatic controls (AC).MethodsTo determine the sensitivity of leukocytes to GC signaling on a transcriptional level, we measured the ex vivo induction of glucocorticoid induced leucine zipper (GILZ) and FK506-binding protein 5 (FKBP5) by GCs in human and murine leukocytes. Targeted tracer metabolomics on peripheral blood mononuclear cells (PBMCs) was performed to detect metabolic changes induced by GCs. ResultsTotal cortisol levels increased in patients with clinical malaria compared to AC and were higher in the SM versus UM group, while cortisol binding globulin levels were unchanged and adrenocorticotropic hormone (ACTH) levels were heterogeneous. Induction of both GILZ and FKBP5 by GCs was significantly reduced in patients with clinical malaria compared to AC and in malaria-infected mice compared to uninfected controls. Increased activity in the pentose phosphate pathway was found in the patients, but this was not affected by ex vivo stimulation with physiological levels of hydrocortisone. Interestingly, hydrocortisone induced increased levels of cAMP in AC, but not in clinical malaria patients. DiscussionAltogether, this study shows that patients with SM have increased cortisol levels, but also a decreased sensitivity to GCs, which may clearly contribute to the severity of disease.

Published
2023
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2. Acceptability of decentralizing childhood tuberculosis diagnosis in low-income countries with high tuberculosis incidence: Experiences and perceptions from health care workers in Sub-Saharan Africa and South-East Asia.

Author

Basant Joshi, Yara Voss De Lima, Douglas Mbang Massom, Sanary Kaing, Marie-France Banga, Egerton Tamba Kamara, Sheriff Sesay, Laurence Borand, Jean-Voisin Taguebue, Raoul Moh, Celso Khosa, Guillaume Breton, Juliet Mwanga-Amumpaire, Maryline Bonnet, Eric Wobudeya, Olivier Marcy, Joanna Orne-Gliemann, and TB-Speed Decentralization study group

Subjects
Public aspects of medicine, RA1-1270
Abstract

Decentralizing childhood tuberculosis services, including diagnosis, is now recommended by the WHO and could contribute to increasing tuberculosis detection in high burden countries. However, implementing microbiological tests and clinical evaluation could be challenging for health care workers (HCWs) in Primary Health Centers (PHCs) and even District Hospitals (DHs). We sought to assess the acceptability of decentralizing a comprehensive childhood tuberculosis diagnosis package from HCWs' perspective. We conducted implementation research nested within the TB-Speed Decentralization study. HCWs from two health districts of Cambodia, Cameroon, Côte d'Ivoire, Mozambique, Sierra Leone, and Uganda implemented systematic screening, nasopharyngeal aspirates (NPA) and stool sample collection with molecular testing, clinical evaluation and chest X-ray (CXR) interpretation. We investigated their experiences and perceptions in delivering the diagnostic package components in 2020-21 using individual semi-structured interviews. We conducted thematic analysis, supported by the Theoretical Framework of Acceptability. HCWs (n = 130, 55% female, median age 36 years, 53% nurses, 72% PHC-based) perceived that systematic screening, although increasing workload, was beneficial as it improved childhood tuberculosis awareness. Most HCWs shared satisfaction and confidence in performing NPA, despite procedure duration, need to involve parents/colleagues and discomfort for children. HCWs shared positive attitudes towards stool sample-collection but were frustrated by delayed stool collection associated with cultural practices, transport and distance challenges. Molecular testing, conducted by nurses or laboratory technicians, was perceived as providing quality results, contributing to diagnosis. Clinical evaluation and diagnosis raised self-efficacy issues and need for continuous training and clinical mentoring. HCWs valued CXR, however complained that technical and logistical problems limited access to digital reports. Referral from PHC to DH was experienced as burdensome. HCWs at DH and PHC-levels perceived and experienced decentralized childhood tuberculosis diagnosis as acceptable. Implementation however could be hampered by feasibility issues, and calls for innovative referral mechanisms for patients, samples and CXR.

Published
2023
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3. Impact of systematic early tuberculosis detection using Xpert MTB/RIF Ultra in children with severe pneumonia in high tuberculosis burden countries (TB-Speed pneumonia): a stepped wedge cluster randomized trial

Author

Aurélia Vessière, Hélène Font, Delphine Gabillard, Laurence Adonis-Koffi, Laurence Borand, Chishala Chabala, Celso Khosa, Sandra Mavale, Raoul Moh, Veronica Mulenga, Juliet Mwanga-Amumpere, Jean-Voisin Taguebue, Mao Tan Eang, Christophe Delacourt, James A. Seddon, Manon Lounnas, Sylvain Godreuil, Eric Wobudeya, Maryline Bonnet, and Olivier Marcy

Subjects
Children, Pneumonia, Tuberculosis, Nasopharyngeal aspirate, Stool, Xpert MTB/RIF ultra, Pediatrics, RJ1-570
Abstract

Abstract Background In high tuberculosis (TB) burden settings, there is growing evidence that TB is common in children with pneumonia, the leading cause of death in children under 5 years worldwide. The current WHO standard of care (SOC) for young children with pneumonia considers a diagnosis of TB only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. As a result, many children with TB-associated severe pneumonia are currently missed or diagnosed too late. We therefore propose a diagnostic trial to assess the impact on mortality of adding the systematic early detection of TB using Xpert MTB/RIF Ultra (Ultra) performed on nasopharyngeal aspirates (NPA) and stool samples to the WHO SOC for children with severe pneumonia, followed by immediate initiation of anti-TB treatment in children testing positive on any of the samples. Methods TB-Speed Pneumonia is a pragmatic stepped-wedge cluster randomized controlled trial conducted in six countries with high TB incidence rate (Côte d’Ivoire, Cameroon, Uganda, Mozambique, Zambia and Cambodia). We will enrol 3780 children under 5 years presenting with WHO-defined severe pneumonia across 15 hospitals over 18 months. All hospitals will start managing children using the WHO SOC for severe pneumonia; one hospital will be randomly selected to switch to the intervention every 5 weeks. The intervention consists of the WHO SOC plus rapid TB detection on the day of admission using Ultra performed on 1 nasopharyngeal aspirate and 1 stool sample. All children will be followed for 3 months, with systematic trial visits at day 3, discharge, 2 weeks post-discharge, and week 12. The primary endpoint is all-cause mortality 12 weeks after inclusion. Qualitative and health economic evaluations are embedded in the trial. Discussion In addition to testing the main hypothesis that molecular detection and early treatment will reduce TB mortality in children, the strength of such pragmatic research is that it provides some evidence regarding the feasibility of the intervention as part of routine care. Should this intervention be successful, safe and well tolerated, it could be systematically implemented at district hospital level where children with severe pneumonia are referred. Trial registration ClinicalTrials.gov, NCT03831906 . Registered 6 February 2019.

Published
2021
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4. Diagnostic Advances in Childhood Tuberculosis—Improving Specimen Collection and Yield of Microbiological Diagnosis for Intrathoracic Tuberculosis

Author

Eric Wobudeya, Maryline Bonnet, Elisabetta Ghimenton Walters, Pamela Nabeta, Rinn Song, Wilfred Murithi, Walter Mchembere, Bunnet Dim, Jean-Voisin Taguebue, Joanna Orne-Gliemann, Mark P. Nicol, and Olivier Marcy

Subjects
tuberculosis, children, diagnosis, microbiological tests, sample collection methods, Medicine
Abstract

There is no microbiological gold standard for childhood tuberculosis (TB) diagnosis. The paucibacillary nature of the disease, challenges in sample collection in young children, and the limitations of currently available microbiological tests restrict microbiological confirmation of intrathoracic TB to the minority of children. Recent WHO guidelines recommend the use of novel rapid molecular assays as initial diagnostic tests for TB and endorse alternative sample collection methods for children. However, the uptake of these tools in high-endemic settings remains low. In this review, we appraise historic and new microbiological tests and sample collection techniques that can be used for the diagnosis of intrathoracic TB in children. We explore challenges and possible ways to improve diagnostic yield despite limitations, and identify research gaps to address in order to improve the microbiological diagnosis of intrathoracic TB in children.

Published
2022
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5. Effect of decentralising childhood tuberculosis diagnosis to primary health centre versus district hospital levels on disease detection in children from six high tuberculosis incidence countries: an operational research, pre-post intervention study

Author

Laurence, Borand, Agathe, de Lauzanne, Bunnet, Dim, Seyla, Heang, Sanary, Kaing, Chanty, Keang, Socheat, L.Y., Pichpiseth, Meas, Sovann, Nhoueng, Long, Pring, Vouchleang, Sreng, Song, Yin, Saren, Sovan, Chanvirak, Phan, Chanra, Chreng, Ratha, Khoun, Monicando, Rin, Sophea, Pal, Boraneath, Nang, Rathakrun, Pom, Tan Eang, Mao, Simoy, Chhim, Huot, Touch, Kosal, Suon, Saronn, Chum, Kimhong, Tok, Kimchorn, Pring, Satya, Krouch, Chean, Chok, Sunleng, Seun, Savtey, Phon, Mai, Nang, Kimda, Hun, Vanny, Hong, Dara, Sok, Kosal, Chea, Bunthoeun, Chheang, Rino, Sem, Lam, Lay, Haysan, Say, Pholly, Kem, Sreyphal, Meng, Sokheng, Phorn, Sreyvann, Him, Peakdey, Pheach, Dalai, Kive, Moeur, Sar, Sreydy, Kong, Seyha, Kong, Sreytouch, Yorn, Soam, Tes, Sophal, Kep, Seroeung HENG Thy, Leng, Savorn, Neak, Sim, Seng, Pheakna, Pay, Sithan, Suon, Sophanna, Chan, Dyna, Um, Savuth, Sin, Sam, Phan, Sarim, Kum, Sokheng, Khath, Pong, Phem, Seyha, Sok, Chanty, Ny, Van, Leim, Sereyvuth, Pich, Sengkry, Chheang, Nhin, Eang, Vannareth, Sao, Vannak, Sim, Sopheak, Som, Ney, Pong, Sokha, Van, Sreyleap, Seng, Vanna, Yoeurng, Kakada, Toem, Thida, Keo, Vuochny, Sem, Sophal, Veng, Chanthol, Rin, Vanny, Seang, Kiri, Lok, Khemra, Mao, Keovanna, Ouk, Maiya, Min, Suomun, Morm, Rattana, Koy, Sreypov, Chhann, Sreytouch, Set, Audrey, Amboua Schouame, Clifford, Babey, Masama, Eden Ngu, Etienne, Guenou, Sylvie, Kwedi Nolna, Douglas, Mbang Massom, Bernard Fortune, Melingui, Nadia, Nga Elomo, Moïse, Mvetumbo, Angeline, Nkembe, Krystel, Ebo, Albert, Kuate Kuate, Michelline, Choupa, Maggi, Mbede, Valerie, Donkeng, Nelly, Kamgaing, Jean-Voisin, Taguebue, Achille, Touha Yannick, Estelle, Abomo Zang, Rosette, Bakoa, Esperance, Mimbouombela Leger, Sabine, Eleme, Gabrielle, Eteme Marie, Thierry, Elouna Nkoa, Dieudonné, Ndzana, Christophe, Bitti, Olivier, Fotsing, Charlotte, Lani Boko, Mathieu, Mbonga, Ghislain Ulrich, Njakou Sagang, Innocent, Onomo, Charlotte, Essaga Hortense, Daniel Desiré, Mboudi Kouang, Léon, Eloundou, Helene, Kengne, Felix, Mbassi, Juliette, Bidjeme, Hortense, Toua Eteme, Nadege, Essama, Roger, Belinga Balla, Norbert, Tassi, Roline, Nguiko Elsa, Leonard, Mekongo, Fabien, Eyebe Ayissi, Francine Christelle, Biloa Anaba, Philomène, Nsom, Celestin Géraud, Yam Essola, Edwige Léa, Mame Moo, Noé, Makon, Arllette Rita, Nounkep Yanghu, Frank, Ebanga, Antoinette, Assiga Ntsama, Carlyle Sorelle, Kamguia Djuimsop, Diane, Mbabou, Marie, Maguip Abanda, Rosine Berthe, Nguemafouo Doummene, Amos, Mekone, Ngwankfu, Konfor Blessing, Jérome, Mimboe, Virginie, Tiona, Roland, Beleck, Sairou, Zam, Nicole, Adibone, Claude, Biaback Jean, Denis, Bessong, Gilbert, Aminou, Jeremie Pagnol, Bille Bonga, Aubin, Fotso Monkap, Epse NGON Annie, Hitekelek, Vitrice, Sebe, Leo, Makon, Marie, Ennah, Mpie, Paul Boyolo, Diane Viviane, Metchoum, Celin, Nzambe, Arnaud, Dado, Milobert, Mbengang, Marceline, Eyebi, Vanessa, Ngah, Alice, Mballa Batonga, Solange, Ayouba, Pierrette, Ebode, Majino, Mamou, Marguerite, Botomogne Bomba, Salametou, Ngnet, Augustine Florence, Essengue Ngono, Rolland, Odionoloba Charles, Bernice, Bisso, Suzy, Balemaken Ingrid, Marie Louise, Mandoki a Bilong, Gertrude, Ndeng Ayouba, Josue, Ngon, Roger, Aka Bony, Kacou Michel, Bah, Dro, Bakayoko, Rolande, Baki Aimee, Marie-France Larissa, Banga, Olivier, Bouzié, Kan, Brou, Pan, Coulibaly, Serge, Danho, Flavien, Deli, Alphonse, Dion, Bi, Do, Armand, Dohoun, William, Edjeme, Cathérine, Falé, Melissa, Gogoua Saulé, Constant, Kesse, Eric, Komena Auguste, Christian, Kouadio, Arkason, Kouame Abel, Raoul, Moh, Sandrine, Nguessan Marcelle, Bertine, Siloué, Nina, Soua, Cyrille Prisca, Yao Yapi, Timothée, Ouassa, Jacquemin, Kouakou, Eric, Balestre, Aurélie, Beuscart, Aurélie, Charpin, Marc, D'elbee, Hélène, Font, Basant, Joshi, Nicolas, Koskas, Olivier, Marcy, Estelle, Occelli, Joanna, Orne-Gliemann, Julien, Poublan, Elodie, Vernoux, Maryline, Bonnet, Savine, Chauvet, Manon, Lounnas, Guillaume, Breton, Pierre-Yves, Norval, Sheyla, Cassy, Verna, Chambal, Valter, Chiúle, Supinho, Chimbanje, Saniata, Cumbe, Mércia, Matsinhe, Celso, Khosa, Nairo, Mabote, Salvador, Machava, Emelva, Machonisse, Verónica, Macuácua, Denise, Milice, Jorge, Ribeiro, Elcídio, Tivane, Dorlim, Uetela, Yara, Voss de Lima, Américo, Zandamela, Alcina, Zita, Ivan, Manhiça, Benedita, José, Dalila, Rego, Chris, Buck W., Kapoli, Kasembe, Atália, Massangaie, Assa, Sitoe, Ambostique, Argola, Césio, Miambo, Presequila, Nhatsave, Gilda, Sitoe, Charifito, Vesta, Salvador, Dimande, Lázaro, Mazembe, Nilza, Amade, Manuela, Chavela, Nomsa, Macheque, Salomão, Comé, Eulália, Machava, Narciso, Mucavele, Jacinto, Nhabanga, Marlene, Nicolau, Natércia, Simbine, Lina, Uendela, Micaela, Juaio, Abiba, Saíde, Naira, Macie, Fernando, Mondlane, Stélio, Simango, Prince, Beyan, Benjamin M, Flomo, Abubakarr, Jalloh Joseph, Ishmael, Kamara, Monica G, Koroma, Mohamed, Lamin, Lena, Matata, Ross, Mugisha Jacob, Christiana M, Senesie, Sheriff, S.E.S.A.Y., Egerton, Tamba Kamara, Ayeshatu, Mustapha, Lynda, Foray, Sandra, Agondeze, Agnes, Kobusingye, Mastula, Nanfuka, Faith, Namulinda, Eric, Wobudeya, Rinah, Arinaitwe, Rodney, Kaitano, Martin, Kasujja, Juliet, Mwanga-Amumpaire, Evans, Mwesigwa, Naome, Natukunda, Simpson, Nuwamanya, Miria, Nyangoma, Patrick, Orikiriza, Johnbosco, Tumwijukye, Esther, Turyashemererwa, Nyehangane, Dan, Mugisha, Ivan, Winnie, Biryeri, George, Naika, Robert, Ongwara O., Allen, Najjuko, Augustine, Kayiira, Samuel, Yairo, Immaculate, Tumwebaze, Goreth, Nalwoga, Paul, Nsiyaleta, Annet, Agaba, Martin, Mpimbaza M., Norbert, Akampurira, Agatha, Tugumisirize, Evans, Ariyo, Julius, Agaba, Yovita, Natukunda, Nelson, Musazi, Edmund, Musinguzi, Brown, Baluku Julius, Moorine, Sekadde, Stavia, Turyahabwe, Chishala, Chabala, Luis, Cuevas, Christophe, Delacourt, Steve, Graham, Malgorzata, Grzemska, Sabine, Verkuijl, Anneke, Hesseling, Elizabeth, Maleche-Obimbo, Mark, Nicol, Wobudeya, Eric, Nanfuka, Mastula, Ton Nu Nguyet, Minh Huyen, Taguebue, Jean-Voisin, Moh, Raoul, Breton, Guillaume, Khosa, Celso, Borand, Laurence, Mwanga-Amumpaire, Juliet, Mustapha, Ayeshatu, Nolna, Sylvie Kwedi, Komena, Eric, Mugisha, Jacob Ross, Natukunda, Naome, Dim, Bunnet, de Lauzanne, Agathe, Cumbe, Saniata, Balestre, Eric, Poublan, Julien, Lounnas, Manon, Ngu, Eden, Joshi, Basant, Norval, Pierre-Yves, Terquiem, Etienne Leroy, Turyahabwe, Stavia, Foray, Lynda, Sidibé, Souleymane, Manhiça, Ivan, Sekadde, Moorine, Detjen, Anne, Verkuijl, Sabine, Mao, Tan Eang, Orne-Gliemann, Joanna, Bonnet, Maryline, and Marcy, Olivier

Published
2024
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6. Effect of systematic tuberculosis detection on mortality in young children with severe pneumonia in countries with high incidence of tuberculosis: a stepped-wedge cluster-randomised trial

Author

Olivier Marcy, Eric Wobudeya, Hélène Font, Aurélia Vessière, Chishala Chabala, Celso Khosa, Jean-Voisin Taguebue, Raoul Moh, Juliet Mwanga-Amumpaire, Manon Lounnas, Veronica Mulenga, Sandra Mavale, Josina Chilundo, Dalila Rego, Bwendo Nduna, Perfect Shankalala, Uzima Chirwa, Agathe De Lauzanne, Bunnet Dim, Emeline Tiogouo Ngouana, Madeleine Folquet Amorrissani, Lassina Cisse, Flore Amon Tanoh Dick, Eric A Komena, Sylvie Kwedi Nolna, Gerald Businge, Naome Natukunda, Saniata Cumbe, Prossy Mbekeka, Ang Kim, Chanrithea Kheang, Sokha Pol, Elizabeth Maleche-Obimbo, James A Seddon, Tan Eang Mao, Stephen M Graham, Christophe Delacourt, Laurence Borand, Maryline Bonnet, Angeline Serre, Anne Badrichani, Manoa Razafimanantsoa, Julien Poublan, Clémentine Roucher, Estelle Occelli, Aurélie Beuscart, Aurélie Charpin, Gemma Habiyambere, Salomé Mesnier, Eric Balestre, Bandana Bhatta, Anne-Laure Maillard, Joanna Orne-Gliemann, Emmanuelle Baillet, Nicolas Koskas, Marc D'Elbée, Delphine Gabillard, Minh Huyen, Hélène Espérou, Sandrine Couffin-Cadiergues, Alexis Kuppers, Benjamin Hamze, Laurence BORAND, Agathe de LAUZANNE, Bunnet DIM, Chanthy Keang, Long PRING, Song YIN, Channimol SARITH, Chanvirak PHAN, Sovann NHEUONG, Socheat LY, Sanary KAING, Vouchleang SRENG, Elen LUN, Leakhena SAY, Sophea SUOM, Romyka FERHY, Dina SO, Sorunna BORN, Sophea PAL, Boraneath NANG, Tan Eang MAO, Ang KIM, Viso Srey, Piseth Kan, leakhena Hout, Samnang Ith, Sophany Oum, Sokunvadhana Sau, Kim Heang Ho, Daronic Kith, Nathara Nuch, Chhun Leang Horm, Cheameas Sophon, Bosba Roeungdeth, Chhay MENG, Ravin RITH, Samnang PHY, Chanchetra SOR, Voleak SAO, Sophea KHAT, Bunthoeun MAK, Angkeaborin UY, Sreyny KHAY, Kimsan SOM, rongvirak HACH, Hay SOK, Sotheavy KUON, Synatt HENG, Amara SENG, Sopheak NIM, Reach PAN, Srean KIM, Keo SREY LEAP, Bormey NET, Viccheka NOUN, Daven LAY, Chhaing MANY, Socheata Seng, Vuthy Ly, Saran So, Sovutthik Oun, Sopheap CHEY, Rattany CHHEA, Lydeth BAONG, Vanna THOUNG, Chanrithea KHEANG, Borady BY, Vathanak Nguon, Eksophea MEACH, Sopheak Tek, Sina Ngeav, Tetra Lun, Deth HEM, Nayreang CHUT, Setha SARIK, Hgekkoung NANG, Mengnean MEACH, Sopal SRENG, Dara SAR, Rathana KIN, Phoran ROS, Chenda DORN, Chansy KAK, Srey Leak Sambath, Leakhena Son, Linda Bin, Eangnay Pengong, Samnang Khutsorn, Sorsophea Seang, Virak Soun, Vuthy Vong, Chandara Khoeung, Panha Um, Sokunthea Bou, Sarin Song Pich, Puthy Nim, Sopheak Khat, Nuon Ban Si, Sovannodom Ream, Sim Ing, Phanith Chann, Samrith Ngeth, Marina Sun, Sokea Chhoeung, Soeun Sean, Ratanak Prak, Audrey Amboua Schouame Onambele, Numfor Hycenth, Bernard Melingui, Angeline Nkembe Medounmga, Luciole Hougnang Tatmi, Nathalie Etemgoua, Vanessa Kouesso, Jean Bugin, Celestine Nzedjom, Roger Ngoya, Jules Eyike, Elyse Loudjom, Roger Lonsti, Ladi Dang, Edward Bintar, Chantal Njayong, Cinthia Ngonsoa O, Isabelle Ndzeukap, Pascaline Dzoyem, Clémentine Dzokou, Berthe Dindo, Eric Auguste Komena, Roger Aka Bony, Christian Kouadio, Serge Danho, Melissa Goli, Madeleine Folquet, Max Valère Itchy, Abdel Sidibé, Lancina Cissé, Joseph Ouattara, Mamadou Konaté, Flore Amon-Tanoh Dick, Melissa Cardena, Laurence Adonis-Koffi, Djabia Eugenie, Ferdinand Kouamé, Hervé Menan, André Inwoley, Timothée Ouassa, Marcelle Sandrine Nguessan, Emelva Manhiça, Alcina Zitha, Valter Chiúle, Eva Muxanga, Irene Gune, Yara Lima, Jorge Ribeiro, Felismina Maxanguana, Natália Morais, Julieta Manhiça, Josefina Give, Jafito Atumane, Gelson Lucas, Arsénio Thai, Adélio Chave, Lúcia Guambe, Faiaz Issa, Rosa Carneiro, Neusa Pene, Natércia Florindo, Dália Machel, Cecília Cumbane, Helena Mendes, Mule Kitungwa, Valdo Muianga, Humberto Tamele, Adelino Sulude, Roda Mabota, Herquéria Comandante, Abelardo Massangaie, Gerald Bright Businge, Faith Namulinda, Robert Sserunjogi, Rashidah Nassozi, Charlotte Barungi, Hellen Aanyu, Doreen Muwonge, Eva Kagoya, Serene Aciparu, Sophia Chemutai, Samuel Ntambi, Amir Wasswa, Juliet Nangozi, Abner Tagoola, Sajja Kenneth, John Paul Lubega, Aidah Nassali, Jessica Tagobera, Christine Agwang, Florence Kalembe, Annet Ajambo, Elizabeth Aguti, Samuel Kasibante, Henry Matende, Israel Owen Odongo, Juliet Mwanga Amumpaire, Gertrude Ngabirano, Paul Kakwenza, Simpson Nuwamanya, Miria Nyangoma, Jane Nabbuto, Florence Abok, Rinah Arinaitwe, Diana Birungi, Evans Mwesigwa, Daniel Atwine, Hassan Mbega, Patrick Orikiriza, Ivan Taremwa, Esther Turyashemererwa, Hope Derrick, Dan Nyehangane, Rodney Kaitano, Susan Logoose, Steven Businge, Charles Ntambi, Jerome Mugabi, John Mzee, Julius Besigye, Saul Kanzira, Phionah Turyatemba, Florence Twebaze, Chimuka Hambulo, Vincent Kapotwe, Marjory Ngambi, Kunda Kasakwa, Chifunda Kapula, Susan Zulu, Grace Nawakwi, Teddy Siasulingana, Jessy Chilonga, Maria Chimbini, Mutinta Chilanga, Muleya Inambao, Mwate Mwambazi, Barbra Halende, Wyclef Mumba, Endreen Mankunshe, Maureen Silavwe, Moses Chakopo, and Roy Moono

Subjects
Infectious Diseases
Abstract

Tuberculosis diagnosis might be delayed or missed in children with severe pneumonia because this diagnosis is usually only considered in cases of prolonged symptoms or antibiotic failure. Systematic tuberculosis detection at hospital admission could increase case detection and reduce mortality.We did a stepped-wedge cluster-randomised trial in 16 hospitals from six countries (Cambodia, Cameroon, Côte d'Ivoire, Mozambique, Uganda, and Zambia) with high incidence of tuberculosis. Children younger than 5 years with WHO-defined severe pneumonia received either the standard of care (control group) or standard of care plus Xpert MTB/RIF Ultra (Xpert Ultra; Cepheid, Sunnyvale, CA, USA) on nasopharyngeal aspirate and stool samples (intervention group). Clusters (hospitals) were progressively switched from control to intervention at 5-week intervals, using a computer-generated random sequence, stratified on incidence rate of tuberculosis at country level, and masked to teams until 5 weeks before switch. We assessed the effect of the intervention on primary (12-week all-cause mortality) and secondary (including tuberculosis diagnosis) outcomes, using generalised linear mixed models. The primary analysis was by intention to treat. We described outcomes in children with severe acute malnutrition in a post hoc analysis. This study is registered with ClinicalTrials.gov (NCT03831906) and the Pan African Clinical Trial Registry (PACTR202101615120643).From March 21, 2019, to March 30, 2021, we enrolled 1401 children in the control group and 1169 children in the intervention group. In the intervention group, 1140 (97·5%) children had nasopharyngeal aspirates and 942 (80·6%) had their stool collected; 24 (2·1%) had positive Xpert Ultra. At 12 weeks, 110 (7·9%) children in the control group and 91 (7·8%) children in the intervention group had died (adjusted odds ratio [OR] 0·986, 95% CI 0·597-1·630, p=0·957), and 74 (5·3%) children in the control group and 88 (7·5%) children in the intervention group had tuberculosis diagnosed (adjusted OR 1·238, 95% CI 0·696-2·202, p=0·467). In children with severe acute malnutrition, 57 (23·8%) of 240 children in the control group and 53 (17·8%) of 297 children in the intervention group died, and 36 (15·0%) of 240 children in the control group and 56 (18·9%) of 297 children in the intervention group were diagnosed with tuberculosis. The main adverse events associated with nasopharyngeal aspirates were samples with blood in 312 (27·3%) of 1147 children with nasopharyngeal aspirates attempted, dyspnoea or SpOSystematic molecular tuberculosis detection at hospital admission did not reduce mortality in children with severe pneumonia. High treatment and microbiological confirmation rates support more systematic use of Xpert Ultra in this group, notably in children with severe acute malnutrition.Unitaid and L'Initiative.For the French translation of the abstract see Supplementary Materials section.

Published
2023

7. Impact of systematic early tuberculosis detection using Xpert MTB/RIF Ultra in children with severe pneumonia in high tuberculosis burden countries (TB-Speed pneumonia): a stepped wedge cluster randomized trial

Author

Mao Tan Eang, Laurence Borand, Maryline Bonnet, Sylvain Godreuil, Olivier Marcy, Raoul Moh, Jean-Voisin Taguebue, Sandra Mavale, Juliet Mwanga-Amumpere, Manon Lounnas, James A Seddon, Veronica Mulenga, Celso Khosa, Eric Wobudeya, Hélène Font, Aurélia Vessière, Chishala Chabala, Laurence Adonis-Koffi, Delphine Gabillard, Christophe Delacourt, Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Zambia [Lusaka] (UNZA), Maputo Central Hospital, Ministry of Health [Mozambique], Centre Hospitalier Universitaire [Treichville] (CHU), Epicentre Ouganda [Mbarara] [Médecins Sans Frontières], Epicentre [Paris] [Médecins Sans Frontières], National Center for Tuberculosis and Leprosy Control [Phnom Penh, Cambodia] (CENAT), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Stellenbosch University, Imperial College London, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Maladies infectieuses et vecteurs : écologie, génétique, évolution et contrôle (MIVEGEC), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche pour le Développement (IRD [France-Sud]), Bugema University [Kampala], Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques et émergentes (TransVIHMI), and Institut de Recherche pour le Développement (IRD)-Université de Yaoundé I-Université Cheikh Anta Diop [Dakar, Sénégal] (UCAD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)

Subjects
Pediatrics, Nasopharyngeal aspirate, Aftercare, 030204 cardiovascular system & hematology, law.invention, Study Protocol, 0302 clinical medicine, Randomized controlled trial, law, Clinical endpoint, Uganda, 030212 general & internal medicine, Cluster randomised controlled trial, Cameroon, Child, Children, Mozambique, Cause of death, lcsh:RJ1-570, Diagnostic Trial, Patient Discharge, 3. Good health, Stool, Child, Preschool, Cambodia, Life Sciences & Biomedicine, medicine.medical_specialty, Tuberculosis, Zambia, Disease cluster, Xpert MTB, Sensitivity and Specificity, 03 medical and health sciences, RIF ultra, medicine, Humans, Xpert, Science & Technology, business.industry, lcsh:Pediatrics, Mycobacterium tuberculosis, Pneumonia, medicine.disease, Xpert MTB/RIF ultra, Pediatrics, Perinatology and Child Health, MTB, 1114 Paediatrics and Reproductive Medicine, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business
Abstract

Background In high tuberculosis (TB) burden settings, there is growing evidence that TB is common in children with pneumonia, the leading cause of death in children under 5 years worldwide. The current WHO standard of care (SOC) for young children with pneumonia considers a diagnosis of TB only if the child has a history of prolonged symptoms or fails to respond to antibiotic treatments. As a result, many children with TB-associated severe pneumonia are currently missed or diagnosed too late. We therefore propose a diagnostic trial to assess the impact on mortality of adding the systematic early detection of TB using Xpert MTB/RIF Ultra (Ultra) performed on nasopharyngeal aspirates (NPA) and stool samples to the WHO SOC for children with severe pneumonia, followed by immediate initiation of anti-TB treatment in children testing positive on any of the samples. Methods TB-Speed Pneumonia is a pragmatic stepped-wedge cluster randomized controlled trial conducted in six countries with high TB incidence rate (Côte d’Ivoire, Cameroon, Uganda, Mozambique, Zambia and Cambodia). We will enrol 3780 children under 5 years presenting with WHO-defined severe pneumonia across 15 hospitals over 18 months. All hospitals will start managing children using the WHO SOC for severe pneumonia; one hospital will be randomly selected to switch to the intervention every 5 weeks. The intervention consists of the WHO SOC plus rapid TB detection on the day of admission using Ultra performed on 1 nasopharyngeal aspirate and 1 stool sample. All children will be followed for 3 months, with systematic trial visits at day 3, discharge, 2 weeks post-discharge, and week 12. The primary endpoint is all-cause mortality 12 weeks after inclusion. Qualitative and health economic evaluations are embedded in the trial. Discussion In addition to testing the main hypothesis that molecular detection and early treatment will reduce TB mortality in children, the strength of such pragmatic research is that it provides some evidence regarding the feasibility of the intervention as part of routine care. Should this intervention be successful, safe and well tolerated, it could be systematically implemented at district hospital level where children with severe pneumonia are referred. Trial registration ClinicalTrials.gov, NCT03831906. Registered 6 February 2019.

Published
2021

8. Mortality and its determinants in antiretroviral treatment-naive HIV-infected children with suspected tuberculosis: an observational cohort study

Author

Olivier Marcy, Mathurin Tejiokem, Philippe Msellati, Khanh Truong Huu, Viet Do Chau, Duong Tran Ngoc, Boubacar Nacro, Francis Ateba-Ndongo, Suzie Tetang-Ndiang, Vibol Ung, Bunnet Dim, Leakhena Neou, Laureline Berteloot, Laurence Borand, Christophe Delacourt, Stéphane Blanche, Sao Sarady Ay, Malen Chan, Phalla Chea, Sophie Goyet, Nimul Roat Men, Phearavin Pheng, Susan Ramsay, Sophea Suom, Arnaud Tarantola, Naisim Te, Sreymom Than, Sovannary Ung, Chorn Chhuk, Chantheany Huot, Sang Han Kath, Sokoeun Khin, Peou Kim, Kim Eng Lim, Phary Lim, Vannareth Lim, Yany Nav, Boren Pich, Sotharin Tuy, Phal Chea, Sengtray Chhraing, Bophal Chuop, Ramy Hem, Phanoeurn Heng, Seng Hap Huon, Sokhorn Khum, Thear Liv, Vichea Ly, Makara Moch, Leakheana Neou, Phanith Rey, Vina Sath, Nopheavann Sun, Pheron Chat, Viso Srey, Sitha Chheang, Putchhat Hor, Manory Oum, Monorea Keo, Sokchea Kou, Sokleaph Cheng, Alexandra Kerleguer, Michel Gomgnimbou, Antoinette Kabore, Anselme Millogo, Zakari Nikiema, Abdul Salam Ouedraogo, Sawadogo Saidou, Moumini Nouctara, Diane Ursule Sangare/Ouattara, Bintou Sanogo, Edgard Sib Sié, Dézémon Zingué, Roger Ngoya Abiguide, Patrice Assene Ngo'o, Francis Ateba Ndongo, Suzanne Balla, Verlaine Bolyse Mbouchong, Jean Marie Ehongo Amanya, Sara Eyangoh, Afi Leslie Kaiyven, Paul Koki Ndombo, Samuel Walter Kokola Bayanak, Marie Josée Mapah Kampaing, Elizabeth Mangoya, Minkala Mvogo, Jean Pierre Ndongo, Laurence Ngassam, Francine Nanda, Sylviane Ndjantou, Jean Audrey Ndongo, Marcelle Njind Nkoum, Anne Esther Njom Lend, Angeline Nkembe, Marie Flore Oyanche, Jean-Voisin Taguebue, Suzy Tetang-Moyo, Sylvie Georgette Zebaze, Thi Oanh Nguyen, Thi Ngoc Lan Nguyen, Catherine Quillet, Khanh Lê Quoc, My Huong To, Thi Kim Phung Tran, Chau Giang Do, Duc Bang Nguyen, Ngo Vi Vi Nguyen, Thi Hieu Nguyen, Thi Thanh Thanh Nguyen, Ngoc Duong Tran, Duy An Vo, Thi Xuan Lan Dang, Thi Kim Phuong Do, Thi Thanh Tuyen Dang, Hoang Chau Nguyen, Ngoc Tuong Vy Pham, Huu Khanh Truong, Chau Viet Do, Bich Ngoc Huynh, Thi Thanh Thuy Le, Thi Thu Hiep Nguyen, Ngoc Luu Tran, Thien An Vu, Huu Loc Tran, Manh Hoang Nguyen, Ngoc Lan Nguyen, Thi Cao Van Nguyen, Thu Hang Pham, Dinh Quyen Phan, Thi Ha Vo, Xuan Lien Truong, Xuan Thinh Vu, Guislaine Carcelain, Sylvain Godreuil, Isabelle Fournier-Nicolle, Institut Pasteur du Cambodge, Institut Pasteur du Cambodge-Réseau International des Instituts Pasteur ( RIIP ), Bordeaux population health ( BPH ), Université de Bordeaux ( UB ) -Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Centre Pasteur du Cameroun, Centre Pasteur du Cameroun-Réseau International des Instituts Pasteur ( RIIP ), Recherches Translationnelles sur le VIH et les maladies infectieuses ( TransVIHMI ), Université Montpellier 1 ( UM1 ) -Université Cheikh Anta Diop ( UCAD ) -Universtié Yaoundé 1 (Cameroun)-Université de Montpellier ( UM ), Service de radiologie pédiatrique [CHU Necker], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Service de Pneumologie Allergologie [CHU Necker], Service d'immunologie, hématologie et rhumatologie pédiatriques [CHU Necker], Réseau International des Instituts Pasteur (RIIP), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques er émergentes (TransVIHMI), Université Cheikh Anta Diop [Dakar, Sénégal] (UCAD)-Institut de Recherche pour le Développement (IRD)-Université de Yaoundé I-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Université Montpellier 1 (UM1), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Service d'immuno-hématologie pédiatrique [CHU Necker]

Subjects
Male, 0301 basic medicine, Pediatrics, medicine.medical_specialty, Tuberculosis, Adolescent, Anti-HIV Agents, Epidemiology, 030106 microbiology, Immunology, Antitubercular Agents, HIV Infections, Kaplan-Meier Estimate, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Virology, Hiv infected, Burkina Faso, medicine, Antiretroviral treatment, Humans, [ SDV.IMM ] Life Sciences [q-bio]/Immunology, Cameroon, 030212 general & internal medicine, Mortality, Child, Coinfection, business.industry, medicine.disease, 3. Good health, Clinical trial, [ SDV.MHEP.MI ] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Infectious Diseases, Vietnam, Child, Preschool, Cohort, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, Observational study, Cambodia, business, Cohort study
Abstract

International audience; BACKGROUND:Tuberculosis is a major cause of morbidity and mortality in HIV-infected children, but is difficult to diagnose. We studied mortality and its determinants in antiretroviral treatment (ART)-naive HIV-infected children presenting with suspected tuberculosis.METHODS:In this observational cohort study, HIV-infected children aged 13 years or younger with suspected tuberculosis were followed up for 6 months as part of the ANRS 12229 PAANTHER 01 cohort in eight hospitals in four countries (Burkina Faso, Cambodia, Cameroon, and Vietnam). Children started ART and antituberculosis treatment at the clinician's discretion and were retrospectively classified into one of three groups by tuberculosis documentation: confirmed by culture or Xpert MTB/RIF, unconfirmed, and unlikely. We assessed mortality and associated factors using Kaplan-Meier methods and Cox proportional hazard models. The ANRS 12229 PAANTHER 01 study is registered at ClinicalTrials.gov, number NCT01331811.FINDINGS:266 (61%) of 438 children enrolled in the study between April 27, 2011, and May 31, 2014, were ART-naive and included in the analysis (40 had confirmed tuberculosis, 119 unconfirmed tuberculosis, and 107 unlikely tuberculosis). 112·5 person-years of follow-up were available. 154 children (58%) started antituberculosis treatment and 212 (80%) started ART. 50 children (19%) died. Mortality by 6 months was higher in children with confirmed tuberculosis (14 deaths; 2 month survival probability 65·0% [95% CI 50·2-79·8]) compared with unconfirmed tuberculosis (19 deaths; 83·5% [76·8-90·3]) and unlikely tuberculosis (17 deaths; 83·5% [76·3-90·7]; log-rank p=0·0141) and was lower in children with confirmed or unconfirmed tuberculosis who started antituberculosis treatment (p

Published
2018

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