HARVEST trial - improving outcomes from TB meningitis with high-dose oral rifampici

Phase 3

• Conditions: Tuberculous meningitis; Infections and Infestations

• Registration Number: ISRCTN15668391
• Lead Sponsor: Makerere College of Health Sciences

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33083560/ protocol (added 23/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Last Update Posted: 15 January 2024
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. First episode TBM suspected by attending physician (>3 days of meningitis symptoms and CSF abnormalities) and anti-TB treatment planned
2. Age =18 years
3. Provision of written informed consent by participant or surrogate

Exclusion Criteria

1. Presence of jaundice, known liver cirrhosis, or known elevated ALT >5x ULN
2. More than 5 doses of any TB treatment received within the previous 7 days
3. Known allergy to: isoniazid, rifampicin, ethambutol, or pyrazinamide
4. Known current/previous rifampicin-resistant M.tb infection
5. Additional active and confirmed CNS infection
6. Corticosteroids contraindicated
7. Cannot or unlikely to attend regular clinic visits
8. Pregnancy or breastfeeding
9. Known renal failure with eGFR <30 ml/min by Modification of Diet in Renal Disease (MDRD) Study equation
10. HIV Protease Inhibitor ongoing use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-month survival