What this study is
This two-stage study will compare consented research participants with tuberculous meningitis receiving BPaLMZ to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE.
What's being tested
- BPaLMZ Regimen
Intervention · DRUG
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide
Study details
- Official title
- A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS
- Sponsor
- David Boulware
- Conditions
- Tuberculous Meningitis · HIV · Meningitis · TB - Tuberculosis
- Enrolling
- 240 people
- Starts
- 2026-07-28
- Est. completion
- 2030-09-30
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openUniversity of Minnesota
Minneapolis, Minnesota, United States
- David Boulware, MD · Contact612-624-9996Coat.trial@gmail.com
2 sites outside the US
Infectious Diseases Institute
Kampala, Uganda
- David Meya, MBChB, MMed, PhD · Contactdavid.meya@idi.co.ug
Mbarara University of Science and Technology
Mbarara, Uganda
- Conrad Muzoora · Contact256772547175conradmuzoora@gmail.com
Study team
Sponsor
David Boulware
Study ID STUDY00024610
Principal investigator
David Boulware, MD
University of Minnesota
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.