Who is sponsoring NEW-STRAT TB?

NEW-STRAT TB is sponsored by University of Cape Town.

What condition does NEW-STRAT TB study?

NEW-STRAT TB studies Disseminated Tuberculosis, HIV.

What drugs are being tested in NEW-STRAT TB?

Interventions: Rifampin, Levofloxacin, Rifampicin, Pyrazinamide, Ethambutol and Isoniazid, Prednisone, Placebo.

What is the status of NEW-STRAT TB?

NEW-STRAT TB is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-12-31 · How we verify

Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis (NEW-STRAT TB)

NCT04951986 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	University of Cape Town
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	732
Start date	2021-08-11
Completion	2026-03

Conditions

Disseminated Tuberculosis
HIV

Interventions

Rifampin
Levofloxacin
Rifampicin, Pyrazinamide, Ethambutol and Isoniazid
Prednisone
Placebo

Primary outcomes

All-cause mortality — 12 weeks

Countries

South Africa