Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGates Medical Research Institute
About this trial
The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.
Eligibility criteria
Qualifiers
Age 18-65 years at consent
Body weight 35-100 kg at screening
Written informed consent obtained
Newly diagnosed rifampicin-sensitive pulmonary TB
Disqualifiers
Prior anti-TB treatment for the current TB episode within 60 days
Prior medication active against Mtb within 3 months
Evidence of extra-thoracic TB, per investigator judgement
Prior treatment completion for TB within 3 years
Trial design
Treatments tested in this trial
- Bedaquiline, pretomanid and TBD09
- Bedaquiline, pretomanid and TBD09
- Bedaquiline, pretomanid and TBD09
- Bedaquiline, pretomanid and TBD09
- Bedaquiline, pretomanid and linezolid
Treatment groups
150 Participants
are divided into 5 treatment groupsLocations
13Enhancing Care Foundation at Wentworth Hospital4052, DurbanBluff, South Africa
TASK Applied Science - Eden6529, GeorgeCentral, South Africa
Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital2092, JohannesburgGauteng, South Africa
The Aurum Institute Tembisa1736, TembisaGauteng, South Africa
Sponsors and collaborators
Gates Medical Research Institute
Lead sponsor
IQVIA RDS Inc.
Collaborator
Source ClinicalTrials.gov