Actively Recruiting
PanACEA - STEP2C -01
Led by Michael Hoelscher · Updated on 2025-10-07
390
Participants Needed
10
Research Sites
245 weeks
Total Duration
On this page
Sponsors
M
Michael Hoelscher
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PanACEA - STEP2C -01
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written, informed consent before trial procedures including HIV testing
- Male or female aged 18 to 65 years
- Body weight between 40 and 90 kg
- Newly diagnosed, previously untreated, drug susceptible pulmonary tuberculosis confirmed by appropriate tests
- Chest X-ray within 2 weeks showing TB-consistent abnormalities
- Positive sputum microscopy or GeneXpert MTB/RIF Ultra result indicating medium or high bacterial load
- Understands dietary restrictions related to study drugs and agrees to follow them
- Not of child-bearing potential or willing to use effective contraception as specified during study and 12 weeks after treatment
- For those with previous TB, must have had good treatment response, completed treatment more than 3 months ago, and no ongoing microbiological positivity
You will not qualify if you...
- Unable to give free and informed consent (e.g., detained or with mental disability)
- Poor general health requiring immediate treatment or likely death within 4 months
- Doubt about ability to complete study follow-up
- Pregnant, breastfeeding, or planning pregnancy during study
- HIV infection with CD4 count below 220 cells/mm3 (with conditions for inclusion if above 220)
- Known allergy or intolerance to study drugs
- History or current serious diseases affecting treatment or survival including significant psychiatric disorders, serious lung diseases other than TB, uncontrolled diabetes requiring certain treatments, cardiovascular diseases, uncontrolled hypertension, long QT syndrome or family history of it, substance abuse
- History of optic neuropathy or vitiligo
- Abnormal lab results including elevated liver enzymes, low kidney function, anemia, low platelets, low potassium uncorrected
- Abnormal ECG findings such as prolonged QTc, AV block, wide QRS, or other relevant changes
- Use of restricted medications or investigational drugs within specified timeframes
- Prior anti-TB treatment within last 3 months
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Centre de Recherches Médicales de Lambaréné (CERMEL)
Lambaréné, Gabon
Completed
2
Kamuzu College of Health Sciences (formerly College of Medicine)
Blantyre, Malawi
Actively Recruiting
3
Instituto Nacional de Saúde (INS)
Maputo, Mozambique
Actively Recruiting
4
Isango Lethemba TB Research Unit. Clinical HIV Research Unit (CHRU), Wits Health Consortium.
Port Elizabeth, Eastern Cape, South Africa, 6003
Not Yet Recruiting
5
TASK Applied Sciences Clinical Research Centre
Cape Town, South Africa, 7500
Actively Recruiting
6
University of Cape Town Lung Institute
Cape Town, South Africa, 7700
Not Yet Recruiting
7
National Institute for Medical Research (NIMR-MMRC)
Mbeya, Mbeya, Tanzania
Actively Recruiting
8
Ifakara Health Institute (IHI)
Bagamoyo, Tanzania
Actively Recruiting
9
Kilimanjaro Clinical Research Institute (KCRI)
Moshi, Tanzania
Actively Recruiting
10
Makerere University Lung Institute Limited
Kampala, Uganda
Actively Recruiting
Research Team
N
Norbert Heinrich, PD Dr.
CONTACT
I
Ivan Noreña, MSc. MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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