Preventive treatment for latent tuberculosis in people with diabetes
A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People With Diabetes
This study is testing if a combination of two medications can help prevent tuberculosis in adults with diabetes who have a latent infection.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute for Medical Research, Tanzania Government |
| Locations | 4 sites (Mbeya and 3 other locations) |
| Trial ID | NCT04600167 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of preventive treatment for latent tuberculosis infection (LTBI) in individuals with diabetes mellitus (DM). Given that DM increases susceptibility to tuberculosis (TB) and worsens patient outcomes, the study aims to assess the safety and efficacy of a regimen involving Isoniazid and Rifapentine compared to a placebo. The trial will include adults diagnosed with LTBI and either known or newly diagnosed DM, with the goal of determining whether preventive therapy can reduce the risk of developing active TB disease. This research addresses a significant gap in current international guidelines regarding LTBI management in diabetic patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of latent tuberculosis infection and diabetes mellitus.
Not a fit: Patients with a history of active tuberculosis disease or those currently receiving treatment for TB will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of active tuberculosis in patients with diabetes, improving their overall health outcomes.
How similar studies have performed: While no randomized controlled trials have previously examined this specific intervention in diabetic patients, the approach is based on evidence from other populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Enrolled in diabetes care with a history of DM and current use of anti-diabetic medication ('known DM'); OR in the absence of anti-diabetic medication an HbA1c of =6.5% (48 mmol/mol) or a fasting venous plasma glucose of =7.0 mmol (126 mg/dl). For those with no previously known DM a repeat test above the diagnostic cut-point is required to confirm the diagnosis ('new DM')
2. Adult (18 years or older)
3. Diagnosed with LTBI, defined as a positive IGRA test or TST reactivity =10 mm
4. Voluntarily signed Informed Consent Form
5. If sexually active, willing to use an effective contraceptive method for the duration of preventive therapy.
Exclusion Criteria:
1. Weight \<45 kg
2. Previous TB disease, defined as either bacteriologically confirmed or clinically diagnosed and treated
3. Treatment with a rifamycin medication or isoniazid in the previous 2 years.
4. Diagnosis of probable or definite TB during screening
5. Confirmed HIV-infection or receiving antiretroviral treatment
6. Liver dysfunction, defined as serum aspartate aminotransferase (AST) level 5 times the upper limit of normal
7. Pregnant or planning to become pregnant in the next 3 months, or lactating
8. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
9. Other conditions inapplicable for participation in this study, such as likely to fail to adhere to study commitment or to complete the whole study, at the discretion of the site investigator
Where this trial is running
Mbeya and 3 other locations
- Mbeya zonal referral hospital — Mbeya, Tanzania (Recruiting)
- Kilimanjaro Christian Medical Center — Moshi, Tanzania (Recruiting)
- Makerere University — Kampala, Uganda (Recruiting)
- Martyrs Hospital Lubaga — Kampala, Uganda (Recruiting)
Study contacts
- Principal investigator: Nyasatu Chamba, MD. — Kilimanjaro Christian Medical Centre,Moshi,Tanzania
- Study coordinator: Issa Sabi, MD, MMed, PhD
- Email: isabi@nimr-mmrc.org
- Phone: +255 25 250 3364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.