Actively Recruiting
Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
Led by Gates Medical Research Institute · Updated on 2026-04-30
150
Participants Needed
13
Research Sites
29 weeks
Total Duration
On this page
Sponsors
G
Gates Medical Research Institute
Lead Sponsor
I
IQVIA RDS Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years at consent
- Body weight between 35 and 100 kg at screening
- Written informed consent obtained
- Newly diagnosed rifampicin-sensitive pulmonary tuberculosis confirmed by molecular tests
- At least one positive acid-fast bacilli smear or positive Xpert MTB/RIF Ultra result
- Chest X-ray showing signs consistent with tuberculosis
- Ability to produce sputum spontaneously
- Women of childbearing potential must use two approved contraceptive methods or practice abstinence
- Men must use contraception or practice abstinence through 90 days after last dose
You will not qualify if you...
- Prior anti-tuberculosis treatment for the current TB episode within the past 60 days
- Use of medications active against Mycobacterium tuberculosis within the last 3 months
- Evidence of tuberculosis outside the lungs
- Completed treatment for tuberculosis within the last 3 years
- Two or more previous tuberculosis episodes
- Significant medical conditions posing safety risks
- If HIV positive: not on antiretrovirals or on them less than 3 months, CD4+ count below 200 cells/uL, viral load above 200 copies/mL, or AIDS-related infections or cancers
- Abnormal laboratory values including liver enzymes, bilirubin, kidney function, blood counts, or positive hepatitis B or C tests
- HbA1c 8.0% or higher
- Current or recent use of systemic immunosuppressive therapy including corticosteroids
- Significant drug or alcohol abuse affecting safety or compliance
- Pregnant, breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Enhancing Care Foundation at Wentworth Hospital
Durban, Bluff, South Africa, 4052
Not Yet Recruiting
2
TASK Applied Science - Eden
George, Central, South Africa, 6529
Actively Recruiting
3
Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital
Johannesburg, Gauteng, South Africa, 2092
Actively Recruiting
4
The Aurum Institute Tembisa
Tembisa, Gauteng, South Africa, 1736
Not Yet Recruiting
5
CHRU @ Isango Lethemba
Bethelsdorp, Gqeberha, South Africa, 6003
Actively Recruiting
6
Madibeng Centre for Research
Brits, North West, South Africa, 0250
Not Yet Recruiting
7
Setshaba Research Center
Pretoria, Soshangue, South Africa, 0152
Not Yet Recruiting
8
ONE MRI
Cape Town, Western Cape, South Africa, 7405
Actively Recruiting
9
TASK Applied Science - Brookylyn Chest Hospital
Cape Town, Western Cape, South Africa, 7405
Actively Recruiting
10
BioMedical Research Institute - Stellenbosch University @ Tygerberg Hospital
Cape Town, Western Cape, South Africa, 7505
Not Yet Recruiting
11
UCT Lung Institute
Cape Town, Western Cape, South Africa, 7700
Not Yet Recruiting
12
Desmond Tutu Health Foundation
Cape Town, Western Cape, South Africa, 7750
Not Yet Recruiting
13
Synergy Biomedical Research Institute (SBRI)
East London, South Africa, 5241
Actively Recruiting
Research Team
G
Gates MRI
CONTACT
G
Gates MRI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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