Challenges in conducting trials for pediatric tuberculous meningitis: lessons from the field
| Autor: | Chhaya Valvi, S. Afrin, Tisungane Mvalo, Ana Arenivas, Kelly E. Dooley, E. Selladurai, Vidya Mave, D. B. Devaleenal, Arti Kinikar, P. Giridharan, Kiran T. Thakur, Mandar Paradkar, Arnab Gupta |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine Research design medicine.medical_specialty Malawi Referral 030106 microbiology Population MEDLINE Antitubercular Agents India Tuberculous meningitis Article law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law 030225 pediatrics medicine Humans education Child education.field_of_study business.industry Infant medicine.disease Clinical trial Infectious Diseases Caregivers Research Design Family medicine Child Preschool Tuberculosis Meningeal business Neurocognitive Follow-Up Studies |
| Zdroj: | Int J Tuberc Lung Dis |
| ISSN: | 1815-7920 |
| Popis: | SETTING: TBM-KIDS is a phase I/II trial enrolling children with tuberculous meningitis (TBM) in three tertiary referral centers in India and Malawi.OBJECTIVE: To describe the challenges encountered in conducting the first randomized clinical trial of antimicrobial agents in pediatric TBM.DESIGN: The sources of the data were primarily monthly trial reports, non-enrollment case report forms, study diaries and registers maintained for recruitment, experiences shared by key team members during regular study calls and comments from site review visits. We reviewed, broadly categorized, and describe in detail the challenges encountered by study teams in trial implementation.RESULTS: Over 17 months, 3371 children with clinical presentations consistent with meningoencephalitis or undergoing lumbar puncture were assessed for eligibility; 21 (CONCLUSION: Interventional trials in pediatric TBM are challenging but are critically important for improving the treatment of a disease that disables children physically, cognitively and emotionally. Sharing these challenges may help to address them more effectively as a TB research community and to advance treatments for this at-risk population. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|