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

Study acronym: NEW-STRAT TB
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jun 30, 2024 to Dec 15, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2024 to Mar 2026
    • Site details revised at 2 of 2 sites
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Jul 15, 2021 to Aug 11, 2021
    v3
  3. Interventions: Levofloxacin (Drug), Placebo (Drug), Prednisone (Drug), Rifamp/Isoniazid/Pyrazinamide 120 Mg-50 Mg-300 Mg ORAL TABLET (Drug), Rifampin… to Levofloxacin (Drug), Placebo (Drug), Prednisone (Drug), Rifampicin, Pyrazinamide, Ethambutol and Isoniazid (Drug), Rifampin (Drug)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04951986
Lead Sponsor University of Cape Town
Conditions
(from sponsor)		 Disseminated Tuberculosis, HIV
Enrollment 732 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov