B-PaLMZ for TB Meningitis | NCT07227779

Studies
B-PaLMZ for TB Meningitis

NCT07227779

Sponsor

University of Minnesota

Status

Not yet recruiting

Last Update Posted

Jun 22, 2026Actual

Enrollment

240Estimated

Phase

Phase 2

Conditions

Tuberculous Meningitis

Interventions

BPaLMZ Regimen

Countries

United States
Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2026Estimated

Primary Completion Date

Aug 31, 2030Estimated

Completion Date

Aug 31, 2030Estimated

First Submitted Date

Nov 11, 2025

First Submission Date that Met QC Criteria

Nov 11, 2025

First Posted Date

Nov 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2026

Last Update Posted Date

Jun 22, 2026Actual

Name	Class
Infectious Diseases Institute	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BPaLMZ Regimen	Experimental	bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide (BPaLMZ)	Drug: BPaLMZ Regimen
Standard of Care Regimen	No Intervention	rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BPaLMZ Regimen	Drug	bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide	BPaLMZ Regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Death		24 Weeks
Functional Status	Modified Rankin score	24 Weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Boulware, MD	Contact	612-624-9996		coat.trial@gmail.com
Darlisha Williams, MPH	Contact	612-624-0469		will1223@umn.edu

Overall Officials

Name	Affiliation	Role
David Boulware, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014390	Tuberculosis, Meningeal

Ancestor Terms

ID	Term
D016920	Meningitis, Bacterial
D020806	Central Nervous System Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

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Browse Branches

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