Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus

Launched by DR. NYANDA ELIAS NTINGINYA · Oct 19, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a preventive treatment for people with diabetes who have a type of tuberculosis called latent tuberculosis infection (LTBI). Latent TB means that the bacteria are present in the body but are not making the person sick. People with diabetes are more likely to develop active TB, so the researchers want to see if a specific treatment called 3HP can help prevent this from happening. The trial is looking for adults aged 18 and older who have diabetes and have been diagnosed with LTBI. Participants will be randomly assigned to receive either the 3HP treatment or a placebo (a harmless dummy treatment) to see if it reduces their risk of developing active TB disease.

To join the trial, participants must be currently receiving treatment for diabetes and have a positive test for LTBI. They should also be able to give consent and, if they are sexually active, agree to use effective birth control during the study. Participants will be monitored throughout the trial and will receive guidance from the healthcare team. This study is important because it aims to provide the first solid evidence on whether preventive treatment for TB is beneficial for people with diabetes, which could help improve health outcomes for this population in the future.

Gender

ALL

Eligibility 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