Bibliographic Details
Title: |
Effectiveness and safety of shortened intensive treatment for children with tuberculous meningitis (SURE): a protocol for a phase 3 randomised controlled trial evaluating 6 months of antituberculosis therapy and 8 weeks of aspirin in Asian and African children with tuberculous meningitis |
Authors: |
Varinder Singh, Naveen Sankhyan, Diana M Gibb, Guy E Thwaites, Hilda Mujuru, James A Seddon, Nitya Wadhwa, Angela Crook, Evelyne Kestelyn, Julie Huynh, Suzanne T Anderson, Nhung Nguyen, Thanh Nguyen, Anna Turkova, Kafula Lisa Nkole, Elena Frangou, Nguyen Viet Nhung, Godfrey Musoro, Chishala Chabala, Kusum Nathoo, Ennie Chidziva, Moses Chitsamatanga, Suvasini Sharma, Phuc Huu Phan, Louise Choo, Tung Huu Trinh, Titiksha Sirari, Constantine Mutata, Anna Griffiths, Eric Wobudeya, Caitlin Muller, Sierra Santana, Lam Van Nguyen, Dai Tran, Susan Abarca-Salazar, Robin Basu-Roy, Sibusiswe Wesa, Vivian Mumbrio, Misheck Phiri, Joyce Chipili Lungu, Christina Zulu, Kriti Nautiyal, Kamal Singhal, Joshua Choga, Secrecy Gondo, Adam Gregory, Yogesh Kumar Tiwari, Mutsa Bwakura, Diksha Shafiq, Ngoc Lam Hong Bao, Shepard Mudzingwa, Nancy Nabukeera |
Source: |
BMJ Open, Vol 15, Iss 4 (2025) |
Publisher Information: |
BMJ Publishing Group, 2025. |
Publication Year: |
2025 |
Collection: |
LCC:Medicine |
Subject Terms: |
Medicine |
More Details: |
Introduction Childhood tuberculous meningitis (TBM) is a devastating disease. The long-standing WHO recommendation for treatment is 2 months of intensive phase with isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E), followed by 10 months of isoniazid and rifampicin. In 2022, WHO released a conditional recommendation that 6 months of intensified antituberculosis therapy (ATT) could be used as an alternative for drug-susceptible TBM. However, this has never been evaluated in a randomised clinical trial. Trials evaluating ATT shortening regimens using high-dose rifampicin and drugs with better central nervous system penetration alongside adjuvant anti-inflammatory therapy are needed to improve outcomes.Methods and analysis The Shortened Intensive Therapy for Children with Tuberculous Meningitis (SURE) trial is a phase 3, randomised, partially blinded, factorial trial being conducted in Asia (India and Vietnam) and Africa (Uganda, Zambia and Zimbabwe). It is coordinated by the Medical Research Council Clinical Trial Unit at University College London (MRCCTU at UCL). 400 children (aged 29 days to |
Document Type: |
article |
File Description: |
electronic resource |
Language: |
English |
ISSN: |
2044-6055 |
Relation: |
https://bmjopen.bmj.com/content/15/4/e088543.full; https://doaj.org/toc/2044-6055 |
DOI: |
10.1136/bmjopen-2024-088543 |
Access URL: |
https://doaj.org/article/c39ba71972c6428ebd413cacd0f9b935 |
Accession Number: |
edsdoj.39ba71972c6428ebd413cacd0f9b935 |
Database: |
Directory of Open Access Journals |