Actively Recruiting
A Multiple-arm, Multiple-stage Open-label, Randomized, Controlled Platform Trial to Evaluate Experimental and Novel Anti-tuberculosis Drugs in Adults With Newly Diagnosed, Drug-sensitive Pulmonary Tuberculosis
Led by Michael Hoelscher · Updated on 2025-10-07
390
Participants Needed
10
Research Sites
8 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
Researchers are investigating new treatment options for adults with newly diagnosed, drug-sensitive pulmonary tuberculosis through a phase 2B/C open-label platform study. The trial compares several experimental drug regimens with a standard control treatment to assess efficacy and safety. Participants include adults aged 18 to 65 years with confirmed pulmonary tuberculosis sensitive to rifampicin and isoniazid. The study aims to optimize doses of existing drugs and introduce new medications to improve treatment outcomes. The study is divided into three stages. In stage 1, participants are randomly assigned to the control or one of two experimental arms containing high-dose rifampicin and other drugs for 12 to 17 weeks. Stage 2 adds an experimental arm including the drug BTZ-043, with participants allocated across four arms in varying ratios. Stage 3 begins after stages 1 and 2 complete enrollment, comparing the control arm with two new experimental arms involving novel drug combinations. Treatments are given once daily, with dosages adjusted by arm and weight. Participants will undergo sputum testing, chest X-rays, and molecular tests to confirm tuberculosis and drug sensitivity before enrollment. During the study, researchers will monitor participants through regular clinical assessments, laboratory tests, and electrocardiograms to track treatment response and safety. The main outcomes measured include time to stable culture conversion and changes in mycobacterial load. Safety is evaluated by recording adverse events and laboratory abnormalities over the treatment period, with follow-up continuing up to 12 months after randomization.
CONDITIONS
Brief Title
PanACEA - STEP2C -01
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written, informed consent before any trial procedures, including HIV testing
- Male or female aged 18 to 65 years, inclusive
- Body weight between 40 and 90 kilograms
- Newly diagnosed, previously untreated, drug susceptible pulmonary tuberculosis confirmed by rapid molecular tests
- Previous tuberculosis allowed if treatment was completed over 3 months ago with no ongoing symptoms and no persistent positive tests
- Chest X-ray consistent with tuberculosis taken within 2 weeks before enrollment
- Positive sputum microscopy or GeneXpert MTB/RIF Ultra result of medium or high on at least one sample
- Understands and agrees to avoid foods that interact with study drugs during treatment
- Not of child-bearing potential or agrees to use effective contraception during and after the study as specified
You will not qualify if you...
- Unable to give free, unconstrained consent (e.g., detained or mentally disabled)
- Poor general health where treatment delay is unsafe or death likely within 4 months
- Unlikely to complete follow-up during study
- Pregnant, breastfeeding, or planning pregnancy during the study
- HIV infection with CD4 count less than 220 cells/mm3, or unable to meet antiretroviral treatment conditions
- Known intolerance to study drugs or contraindicating medical conditions
- History or current severe diseases affecting heart, metabolism, nervous system, liver, kidneys, psychiatric status, or cancer
- Neuropathy or significant psychiatric disorders requiring treatment
- Significant extra-pulmonary tuberculosis or serious lung conditions other than tuberculosis
- Uncontrolled diabetes or hypertension
- Long QT syndrome or family history of sudden cardiac death
- Substance abuse affecting safety or cooperation
- Laboratory abnormalities including elevated liver enzymes, low hemoglobin or platelets, low potassium after correction
- ECG abnormalities including prolonged QTc, AV block, or other clinically relevant changes
- Recent treatment with other investigational drugs or anti-TB drugs active against tuberculosis within 3 months
- Unable or unwilling to follow medication restrictions during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 to 26 weeks depending on treatment arm
Participants receive assigned anti-tuberculosis drug regimens consisting of various drugs including rifampicin, isoniazid, pyrazinamide, moxifloxacin, BTZ-043, alpibectir, ethionamide, ganfeborole, delpazolid, pretomanid, and ethambutol, depending on their assigned treatment arm.
Weekly visits for up to 26 weeks
Duration - Up to 12 months after treatment start
Participants are monitored for relapse-free survival and adverse events after completion of treatment.
Periodic visits during follow-up period
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.
I
Ivan Noreña, MSc. MD
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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