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Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis

NCT04951986 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 732

Last updated 2026-01-06

No results posted yet for this study

Summary

The New Strat-TB trial is a superiority Phase III randomised control clinical trial with a 2X2 factorial design. The main aim of the study is to assess the efficacy and safety of high dose rifampicin and levofloxacin for 14 days in addition to standard TB therapy with or without steroids among adults hospitalized with HIV-associated disseminated tuberculosis.

The investigators hypothesize that intensified treatment with increased rifampicin doses at 35 mg/kg plus levofloxacin will more rapidly reduce the mycobacterial load. The investigators also hypothesize that steroids will have an immune-modulatory effect and dampen the activation of the innate immune system. The investigators hypothesize that these two strategies will lead to improved survival in patients hospitalized with HIV-associated disseminated tuberculosis.

Conditions

  • Disseminated Tuberculosis
  • HIV

Interventions

DRUG

Rifampin

Rifampicin up to 35 mg/kg/day for 14 days

DRUG

Levofloxacin

Levofloxacin 750mg daily (for weight \<50kg) or 1 g daily (for weight \>50 kg) daily for 14 days

DRUG

Rifampicin, Pyrazinamide, Ethambutol and Isoniazid

Rifampicin 10 mg/kg; Isoniazid 5 mg/kg; Pyrazinamide 15 mg/kg; Ethambutol15 mg/kg in fixed dose combination administered per weight band. Standard of care control arm

DRUG

Prednisone

Prednisone 1.5mg/kg/day for 14 days

DRUG

Placebo

Placebo identical to Prednisone

Sponsors & Collaborators

  • University of Cape Town

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2025-12-15
Completion
2026-03-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04951986 on ClinicalTrials.gov