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Outcome Measures

Primary Outcomes (1)

Drug exposure in PCF and mediates in Mtb load
To determine whether higher dose rifampicin (35mg/kg) increases pericardial fluid (AUC) RIF levels and increases time to positivity of mycobacterial culture at 72 hours compared to standard dose Rifampicin
72 hours and 52 weeks

Secondary Outcomes (5)

Mortality between study arms
week 8 and 52 weeks
re-accumulation of pericardial effusion between study arms
52 weeks
TB-IRIS between study arms
52 weeks
Constrictive pericarditis between the study arms
52 weeks
CMR evidence
52 weeks

Other Outcomes (5)

To investigate the safety and tolerability of RIF35 for PCTB by:
week 8 and 52 weeks
Discontinuation rate
52 weeks
Change in Mtb bacterial load
72 hours
+2 more other outcomes

Study Arms (2)

Arm 1: Standard of care (RIF10)

NO INTERVENTION

Dosing of the daily oral RHZE fixed dose combination (FDC) will be according to WHO weight bands

Arm 2: High-dose RIF (RIF35)

EXPERIMENTAL

Simulations were performed to determine the dose of RIF required to achieve the most equitable drug exposures across the weight range, 30 to 100 kg. Demographic data of a reference cohort of TB patients (n = 1225), with or without HIV-1 coinfection, recruited in clinical trials conducted in West Africa and South Africa were used for the simulations35-38. An additional 12 250 virtual patients were generated using the weight and height distributions of the 1225 patients to increase the number of patients with a weight close to the boundaries of the weight range. Parameter estimates of the population PK model for RIF were used to simulate (100 replicates) RIF exposures22. Four dosing scenarios were evaluated using the weight-band based dosing with 4-drug FDC tablets and extra RIF tablets with each tablet containing 150 mg or 600 mg RIF. The FDC tablets were assumed to have 20% reduced bioavailability based on data from a clinical trial where the same formulation was used39

Drug: high dose Rifampicin (RIF)

Interventions

high dose Rifampicin (RIF)Drug

Arm 2: High-dose RIF (RIF35)

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MeSH Terms

Conditions

Pericarditis, Tuberculous

Interventions

Rifampin

Condition Hierarchy (Ancestors)

Tuberculosis, CardiovascularTuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsCardiovascular InfectionsCardiovascular DiseasesPericarditis

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

TRIPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR

Masking Details

Neither participants nor the investigators will be aware of the participant's treatment allocation until the end of the study (double blinding). Blinding will be maintained by manufacture of placebo tablets similar in appearance and packaging to that of the study drug, with centralized dispensing by the study pharmacist. Unmasking procedures are detailed by SOP.

Purpose

BASIC SCIENCE

Intervention Model

PARALLEL

Model Details: Participant identification numbers (PID), assigned at the screening visit, will be used throughout the study. After signing the informed consent document; eligible participants will be stratified by HIV status and then further stratified by GX-Ultra status to ensure equal allocation regardless of HIV status and likely subsequent culture status. An electronic randomization tool will be used to randomize the subgroups in a 1:1 ratio. The randomization list will be generated and updated by the study coordinator, trial pharmacist, or statistician who will have no direct contact with trial participants or involvement with the assessment for eligibility in the trial.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

National Principal Investigator

High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (5)

Study Arms (2)

Arm 1: Standard of care (RIF10)

Arm 2: High-dose RIF (RIF35)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (5)

Study Arms (2)

Arm 1: Standard of care (RIF10)

Arm 2: High-dose RIF (RIF35)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations