Condition: Pulmonary Tuberculosis · Other Specified Pulmonary Tuberculosis · Sponsor: Michael Hoelscher
This is a phase 2B/C, open label platform study that will compare the efficacy, safety of experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4 in a ratio of 1:1:1:2. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2. In stage 3, participants will be allocated in parallel to control arm treatment (now designated arm 7) or the experimental arms 5 and 6, favouring arm 5, 2:1:1 over arms 6 and control. This stage will start after completion of recruitment in the stages 1 and 2. Enrolment of participants into arm 5 will proceed following review of data from the ENABLE/UNITE-03 (NCT06748937), non-clinical safety data and after endorsement by the DSMB. Thus, arm 5 recruitment might start after arms 6 and 7, which may require an increase in the control arm sample size to ensure controls are recruited concomitantly.
This description comes directly from the study's public registry record.
Norbert Heinrich, PD Dr. · +49894400 · Norbert.Heinrich@med.uni-muenchen.de
Ivan Noreña, MSc. MD · +49894400 · Ivan.Norena@med.uni-muenchen.de
Always discuss trial participation with your own doctor first.
| Centre de Recherches Médicales de Lambaréné (CERMEL) | Lambaréné, Gabon | Completed |
| Kamuzu College of Health Sciences (formerly College of Medicine) | Blantyre, Malawi | Recruiting |
| Instituto Nacional de Saúde (INS) | Maputo, Mozambique | Recruiting |
| Isango Lethemba TB Research Unit. Clinical HIV Research Unit (CHRU), Wits Health Consortium. | Port Elizabeth, Eastern Cape, South Africa | Not Yet Recruiting |
| TASK Applied Sciences Clinical Research Centre | Cape Town, South Africa | Recruiting |
| University of Cape Town Lung Institute | Cape Town, South Africa | Not Yet Recruiting |
| National Institute for Medical Research (NIMR-MMRC) | Mbeya, Mbeya, Tanzania | Recruiting |
| Ifakara Health Institute (IHI) | Bagamoyo, Tanzania | Recruiting |
| Kilimanjaro Clinical Research Institute (KCRI) | Moshi, Tanzania | Recruiting |
| Makerere University Lung Institute Limited | Kampala, Uganda | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05807399