Study of Combinations of Novel Promising Drugs for Pulmonary Tuberculosis
ConditionTuberculosis, Pulmonary
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTASK Applied Science
About this trial
A phase 2, two-part, multicentre, open label, controlled, randomised clinical trial in adult participants with newly diagnosed, sputum-positive pulmonary drug-sensitive tuberculosis (DSTB). Assessing the Safety and Efficacy of TBAJ-587 as Part of a Combination Regimen in Newly Diagnosed, Drug-Sensitive, Sputum-Positive Pulmonary Tuberculosis
Eligibility criteria
Qualifiers
Provide written informed consent.
Male or female aged 18-65 (inclusive)
Symptoms consistent with pulmonary TB at screening AND/OR
Imaging findings consistent with active pulmonary TB on chest X-ray performed at screening or within 15 days prior to screening.
Disqualifiers
Taken more than 1 daily dose of medication with anti-tuberculous activity during the 14 days prior to randomisation (isoniazid, rifampicin, pyrazinamide, ethambutol, linezolid, moxifloxacin, levofloxacin or amikacin).
Known or suspected extra-thoracic TB, miliary TB or disseminated TB (in the judgement of the investigator; note uncomplicated pleural effusion occupying <50% of hemithorax or concomitant intra- or extra-thoracic lymphadenopathy are not exclusions).
Severe clinical pulmonary TB e.g. respiratory failure or complications, likely to require hospital admission in the opinion of the investigator.
Poor general condition (Karnofsky score ≤50) OR where any delay in treatment cannot be tolerated in the opinion of the investigator.
Trial design
Treatments tested in this trial
- TBAJ-587 50 mg
- Pretomanid 200mg
- Linezolid 600Mg Tab
- BTZ-043 250 mg or 500 mg
- HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)
- Quabodepistat (Q) 30 mg
- Ganfeborole 20 mg
Treatment groups
135 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov