Prevention of tuberculosis in people with diabetes Infections and Infestations
Conditions
Interventions
Current interventions as of 18/03/2025:
There are two arms:
1. Intervention arm - a 1-month regimen (total treatment duration) of daily Rifapentine (600 mg) and Isoniazid (300 mg) in addition to the s
Sponsors
University of Cape Town
Eligibility
Sex/Gender
All
Age
15 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Male and female, age =15 years old, living in the study area at the time of signing the informed consent form 2. Diabetes Mellitus (all types) receiving care, with or without the presence of other non-communicable diseases 3. HIV-negative 4. Positive Interferon-gamma release assays (IGRA) 5. Able to understand and give informed consent form (witnessed consent if the person is illiterate)
Exclusion criteria
Exclusion criteria: 1. TPT already recommended in standard of care as per WHO guidelines for TB care (people living with HIV or contacts); 2. Current treatment with fluoroquinolones or other antibiotics with anti-tuberculous activity; 3. Contraindications to study drugs (Rifapentine or Isoniazid), including those who must continue medications that are not permitted with the study drugs (see section 4. Participants who are breastfeeding, pregnant, or of childbearing potential* who do not agree to use an effective method of contraception** from the time consent is signed until 4 weeks after discontinuation or completion of the IMP; 5. Previous active TB within 1 year; 6. Previous course of TPT within 1 year; 7. ALT over three times upper limit of normal (ULN) at baselineOther clinical conditions deemed ineligible for LTBI treatment by the clinician (e.g. clinical diagnosis of cirrhosis), as per national and local guidelines on provision of TB preventive treatment. 8. Social context (e.g excessive active alcohol use) likely to impact ability to understand, provide consent or adhere to the study schedule, as assessed by the study investigator. 9. Presence of active TB disease; *A woman of child bearing potential (WOCBP): 12 years of age or older having had their first menstruation and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. **Effective contraception: only barrier (including spermicidal gel) or intrauterine contraceptive measures within the trial period. Hormonal contraceptives, including oral contraceptives, intramuscular, and implant contraception are not considered effective methods due to drug interactions with rifampicin/rifapentine, which results in loss of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Updated 30/10/2026: Previous Primary outcome: Microbiologically confirmed active TB disease measured using Xpert® MTB/RIF Ultra or standard culture over 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/01/2026: 1. The following alternate effectiveness outcome variables will be measured using provincial healthcare data and clinical notes/ laboratory results over 1 year, 2 years, and up to 4 years: 1.1. Probable and definite diagnosis of TB disease 1.2. Probable, possible or definite diagnosis of TB disease or death from any cause except violent or accidental deaths 1.3. Disease-specific deaths (including TB, caused by or related to diabetes, including cardiovascular deaths) 1.4. Microbiologically confirmed active TB regardless of symptoms and chest X-ray abnormality 1.5. Sub-clinical TB (microbiologically confirmed active TB without signs and symptoms) 2. Safety outcome variables will be measured using provincial healthcare data and clinical notes/ laboratory results: 2.1. Pre-specified clinically relevant grade =3 AE: clinical hepatitis, elevated liver enzymes (transaminases), peripheral neuropathy, rashes, hospitalisation within 12 weeks 2.2. Any Grade =3 AE (except related to violent or accidental deaths) within 12 weeks 2.3. Serious adverse events within 12 weeks 2.4. Treatment discontinuation due to any AE 2.5. Rifampicin-resistant TB at measured throughout the clinical trial until end of study visit 2.6. Progression or exacerbations of clinical condition(s) and biomarkers measured using provincial healthcare data, clinical and laboratory records within 1 year, including: 2.6.1. HbA1c 2.6.2. Diabetes-related complications (retinopathy and neuropathy) 2.6.3. Blood pressure 2.6.4. Total cholesterol and LDL cholesterol 2.6.5. Estimated glomerular filtration rate (eGFR) 2.6.6. Change in the management of diabetes 2.6.7. Emergency room admission for at least 24 hours 2.6.8. Unplanned care visits 2.7 Incident of cardiovascular events (a composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) 3. Process outcomes measured using provincial healthcare data, clinical an | — |
Countries
Philippines, South Africa
Contacts
Public ContactMolebogeng X. Rangaka
Outcome results
None listed