B-PaLMZ for TB Meningitis

ConditionTuberculous Meningitis

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

BPaLMZ Regimen
Drug
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: BPaLMZ RegimenExperimental treatment 1 intervention

Group B: Standard of Care RegimenNo intervention 0 interventions

Trial outcomes

Primary outcomes

Time to Death

Time frame

24 Weeks

Functional Status

Modified Rankin score

Time frame

24 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Infectious Diseases Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: