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Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis
Sponsor: University of Cape Town
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
732
Start Date
2021-08-11
Completion Date
2026-03
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
Rifampin
Rifampicin up to 35 mg/kg/day for 14 days
Levofloxacin
Levofloxacin 750mg daily (for weight \<50kg) or 1 g daily (for weight \>50 kg) daily for 14 days
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
Prednisone
Prednisone 1.5mg/kg/day for 14 days
Placebo
Placebo identical to Prednisone
Locations (2)
Khayelitsha Hospital, c/o Steve Biko and Walter Sisulu Drives, Khayelitsha
Cape Town, Western Cape, South Africa
Mitchells Plain Hospital, Mitchells PLain
Cape Town, Western Cape, South Africa