Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
High-dose isoniazid or rifampicin for recurrent tuberculosis
NCT03862248Phase 3
Key facts
- Status
- Withdrawn
- Start
- Sep 2019
- Primary completion
- Oct 2022
- Countries
- 1
- Sponsor
- Institute of Tropical Medicine Antwerp
- Modality
- Small Molecules
- Drugs
- isoniazidrifampicin
- Conditions
- Tuberculosis (TB)
01
Overview
Phase 3, randomised, open-label trial of isoniazid and rifampicin in Tuberculosis (TB) (3 arms), sponsored by Institute of Tropical Medicine Antwerp. Primary endpoint: Bacteriological effectiveness (proportion of relapse-free cure excluding deaths and lost-to-follow-up) at 18 months. Planned start Sep 2019; status: withdrawn.
02
Design
3 arms- Study design
- RandomizedOpen-label
High-Dose Isoniazid
6EH³RZ (H 15mg/kg)
High-Dose Rifampicin
6EHR³Z (R 30mg/kg)
World Health Organisation (WHO) regimen
6EHRZLfx (Standard doses + Levofloxacin)
03
Who it enrols
Newly registered patients with smear-positive recurrent pulmonary tuberculosis, excluding HIV co-infection.
04
Endpoints
Primary
Bacteriological effectiveness (proportion of relapse-free cure excluding deaths and lost-to-follow-up)
Secondary
Frequency of resistance to the different drug components at screening
Identify predictors of bacteriological effectiveness
Programmatic effectiveness (proportion of participants with relapse-free cure)
Number of SAEs and study-specific adverse events of the different retreatment regimens
Negative predictive value of two-week FDA
Proportion of participants relapse-free cure
Difference (95% confidence interval) in bacteriological effectiveness (susceptible to both rifampicin and isoniazid vs heteroresistance to rifampicin and/or isoniazid)
Proportion of participants with acquired resistance
Beyond the preview
Go deeper on NCT03862248.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03862248.