| NCT ID | NCT07227779 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | David Boulware |
| Condition | Tuberculous Meningitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2026-07-28 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 312 participants in total. It began in 2026-07-28 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This two-stage study will compare consented research participants with tuberculous meningitis receiving experimental Bedaquiline (B), Pretomanid (Pa), Linezolid (L); Moxifloxacin (M), Pyrazinamide (Z) known as (BPaLMZ) to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE. The experimental regimen is known as 1BPaLMZ/5PaM.
Eligibility Criteria
Inclusion Criteria: * First Episode definite or probable TBM with physician intent to treat * Age ≥18 years * Provision of Informed Consent by participant or surrogate * Living with HIV * Weight \> 35kg, estimate or measured Exclusion Criteria: * Additional active and confirmed CNS infection * Known rifampicin-resistant TB * Allergy or contraindication to a study medicine * More than 5 doses of any TB therapy received within the previous 14 days * Presence of jaundice, known liver cirrhosis, elevated ALT or AST \>3x ULN, or total bilirubin \>2x ULN * Estimated Glomerular Filtration Rate \<30 ml/min/1.73m2 * Significant cardiac comorbidity, heart failure, arrhythmia, or QTc \>450 ms * Pregnancy or Breastfeeding * Cryptococcal antigen positivity in blood * Condition which makes participation not in the participant's best interest
Contact & Investigator
David Boulware, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT07227779 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tuberculous Meningitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07227779 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07227779 currently recruiting?
Yes, NCT07227779 is actively recruiting participants. Contact the research team at coat.trial@gmail.com for enrollment information.
Where is the NCT07227779 trial being conducted?
This trial is being conducted at Kampala, Uganda, Mbarara, Uganda.
Who is sponsoring the NCT07227779 clinical trial?
NCT07227779 is sponsored by David Boulware. The principal investigator is David Boulware, MD at University of Minnesota. The trial plans to enroll 312 participants.