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2 results on '"Justina Bramugy"'

1. Adjunctive rosiglitazone treatment for severe pediatric malaria: A randomized placebo-controlled trial in Mozambican children

Author

Rosauro Varo, Valerie M. Crowley, Humberto Mucasse, Antonio Sitoe, Justina Bramugy, Lena Serghides, Andrea M. Weckman, Clara Erice, Rubao Bila, Pio Vitorino, Campos Mucasse, Marta Valente, Sara Ajanovic, Núria Balanza, Kathleen Zhong, Yiovanna Derpsch, Melissa Gladstone, Alfredo Mayor, Quique Bassat, and Kevin C. Kain

Subjects
Adjunctive, Treatment, Plasmodium falciparum, Malaria, Severe, Rosiglitazone, Infectious and parasitic diseases, RC109-216
Abstract

Objectives: We tested the hypothesis that adjunctive rosiglitazone treatment would reduce levels of circulating angiopoietin-2 (Angpt-2) and improve outcomes of Mozambican children with severe malaria. Methods: A randomized, double-blind, placebo-controlled trial of rosiglitazone vs placebo as adjunctive treatment to artesunate in children with severe malaria was conducted. A 0.045 mg/kg/dose of rosiglitazone or matching placebo were administered, in addition to standard of malaria care, twice a day for 4 days. The primary endpoint was the rate of decline of Angpt-2 over 96 hours. Secondary outcomes included the longitudinal dynamics of angiopoietin-1 (Angpt-1) and the Angpt-2/Angpt-1 ratio over 96 hours, parasite clearance kinetics, clinical outcomes, and safety metrics. Results: Overall, 180 children were enrolled; 91 were assigned to rosiglitazone and 89 to placebo. Children who received rosiglitazone had a steeper rate of decline of Angpt-2 over the first 96 hours of hospitalization compared to children who received placebo; however, the trend was not significant (P = 0.28). A similar non-significant trend was observed for Angpt-1 (P = 0.65) and the Angpt-2/Angpt-1 ratio (P = 0.34). All other secondary and safety outcomes were similar between groups (P >0.05). Conclusion: Adjunctive rosiglitazone at this dosage was safe and well tolerated but did not significantly affect the longitudinal kinetics of circulating Angpt-2.

Published
2024
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2. Neurodevelopmental and growth outcomes after invasive Group B Streptococcus in early infancy: A multi-country matched cohort study in South Africa, Mozambique, India, Kenya, and Argentina

Author

Proma Paul, Jaya Chandna, Simon R. Procter, Ziyaad Dangor, Shannon Leahy, Sridhar Santhanam, Hima B. John, Quique Bassat, Justina Bramugy, Azucena Bardají, Amina Abubakar, Carophine Nasambu, Romina Libster, Clara Sánchez Yanotti, Farah Seedat, Erzsébet Horváth-Puhó, A.K.M. Tanvir Hossain, Qazi Sadeq-ur Rahman, Mark Jit, Charles R. Newton, Kate Milner, Bronner P. Gonçalves, Joy E. Lawn, Shabir A. Madhi, Lois Harden, Azra Ghoor, Sibongile Mbatha, Sarah Lowick, Barbara Laughton, Tamara Jaye, Sanjay G Lala, Pamela Sithole, Jacqueline Msayi, Ntombifuthi Kumalo, Tshepiso Nompumelelo Msibi, Asha Arumugam, Nandhini Murugesan, Nandhini Rajendraprasad, Mohana Priya, Adam Mabrouk Adan, Patrick Vidzo Katana, Eva Mwangome, Humberto Mucasse, Celine Aerts, Sergio Massora, Valeria Medina, Andrea Rojas, Daniel Amado, Conrado J. Llapur, and group, GBS long term outcomes LMIC collaborative

Subjects
Disability, children, Group B streptococcus, Impairment, Sepsis, Neurodevelopment, Meningitis, General Medicine, Infants
Abstract

Background Data are limited regarding long-term consequences of invasive GBS (iGBS) disease in early infancy, especially from low- and middle-income countries (LMIC) where most cases occur. We aimed to estimate risk of neurodevelopmental impairment (NDI) in children with a history of iGBS disease. Methods A multi-country matched cohort study was undertaken in South Africa, India, Mozambique, Kenya, and Argentina from October 2019 to April 2021. The exposure of interest was defined as a history of iGBS disease (sepsis or meningitis) before 90 days of age, amongst children now aged 1·5–18 years. Age and sex-matched, children without history of GBS were also recruited. Age-appropriate, culturally-adapted assessments were used to define NDI across multiple domains (cognitive, motor, hearing, vision, emotional-behaviour, growth). Pooled NDI risk was meta-analysed across sites. Association of iGBS exposure and NDI outcome was estimated using modified Poisson regression with robust variance estimator. Findings Amongst 138 iGBS survivors and 390 non-iGBS children, 38·1% (95% confidence interval [CI]: 30·0% – 46·6%) of iGBS children had any NDI, compared to 21·7% (95% CI: 17·7% - 26·0%) of non- iGBS children, with notable between-site heterogeneity. Risk of moderate/severe NDI was 15·0% (95% CI: 3·4% - 30·8%) among GBS-meningitis, 5·6% (95% CI: 1·5% - 13·7%) for GBS-sepsis survivors. The adjusted risk ratio (aRR) for moderate/severe NDI among iGBS survivors was 1.27 (95% CI: 0.65, 2.45), when compared to non-GBS children. Mild impairment was more frequent in iGBS (27.6% (95% CI: 20.3 – 35.5%)) compared to non-GBS children (12.9% (95% CI: 9.7% - 16.4%)). The risk of emotional-behavioural problems was similar irrespective of iGBS exposure (aRR=0.98 (95% CI: 0.55, 1.77)). Interpretation Our findings suggest that iGBS disease is on average associated with a higher risk of moderate/severe NDI, however substantial variation in risk was observed between sites and data are consistent with a wide range of values. Our study underlines the importance of long-term follow-up for at-risk neonates and more feasible, standardised assessments to facilitate diagnosis in research and clinical practice. Funding This work was supported by a grant (INV-009018) from the Bill & Melinda Gates Foundation to the London School of Hygiene & Tropical Medicine.

Published
2022
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