Health Trials

B-PaLMZ for TB Meningitis

ConditionsTuberculous MeningitisHIVMeningitisTB - Tuberculosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Boulware

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

1

Time to Death

Time frame
24 Weeks
2

Hierarchical composite endpoint (survival + functional status)

Hierarchical composite endpoint of survival and modified Rankin score (0-6 scale) assessed by Win Ratio

Time frame
24 Weeks

Secondary outcomes

1

Serious adverse events (SAE)

Incidience of Serious adverse events

Time frame
28 weeks
2

Clinical Adverse Events

Clinical Adverse Events, by grade (1-5) associated with TB drug discontinuation, dose reduction, or interruption \>3 days

Time frame
28 weeks
3

Laboratory abnormalities

Number of participants with grade 3 or 4 abnormal laboratory values, by the Division of AIDS toxicity grading scale

Time frame
28 weeks
4

Neuropathy

Incidence of Neuropathy

Time frame
28 weeks

Other outcomes

Sponsors and contacts

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

David Boulware

Lead sponsor

University of Minnesota

Sponsor institution

Infectious Diseases Institute, Uganda

Collaborator

University of Minnesota

Collaborator

Brighton & Sussex Medical School

Collaborator

Mbarara University of Science and Technology

Collaborator

Radboud University Medical Center

Collaborator

Meningitis Foundation

Collaborator

Source ClinicalTrials.gov
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