Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04600167
Other study ID # NIMR-MB-002
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 17, 2022
Est. completion date December 2025

Study information

Verified date March 2023
Source National Institute for Medical Research, Tanzania
Contact Issa Sabi, MD, MMed, PhD
Phone +255 25 250 3364
Email isabi@nimr-mmrc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Diabetes mellitus (DM) increases susceptibility to Tuberculosis (TB) and worsens TB patient outcomes. The number of patients with combined TB and DM now outnumbers that of combined TB and HIV and it has been estimated that 15-30% of TB disease may be attributable to diabetes globally. This may be expected to rise substantially as DM prevalence increases. Treatment of Latent TB Infection (LTBI) in this population will likely have a significant clinical benefit. Similar to HIV-infected individuals, those with DM might benefit from therapy to prevent the development of TB disease. Current international guidelines do not recommend LTBI management in people with DM, but this is because no studies have examined the risk-benefit ratio of such an intervention. To date, no RCTs have been conducted to investigate the efficacy and safety of preventive treatment of LTBI in DM patients. Based on evidence on effectiveness, safety, and treatment completion rates, 3HP has been selected as the regimen of choice for this study of African people living with DM. People living with DM will be randomized to 3HP or placebo to determine the efficacy of 3HP in the prevention of TB disease in this population. PROTID's preventive treatment of LTBI among people with DM will generate the first solid evidence to support or refute the use of preventive treatment against TB in people with DM.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Isoniazid and Rifapentine (INH-RPT)
Oral combination of rifapentine (RPT, 900 mg) and isoniazid (INH, 900 mg), once-weekly for 12 weeks.
Placebo
Participants in the control group will receive placebo once weekly for 12 weeks

Locations

Country Name City State
Tanzania Mbeya zonal referral hospital Mbeya
Tanzania Kilimanjaro Christian Medical Center Moshi
Uganda Makerere University Kampala
Uganda Martyrs Hospital Lubaga Kampala

Sponsors (8)

Lead Sponsor Collaborator
Dr. Nyanda Elias Ntinginya Kilimanjaro Christian Medical University College (KCMUCo), Tanzania, King's College London, Makerere University, Otago University, New Zealand, St George's, University of London, United Kingdom, Stichting Katholieke Universiteit- Radboudumc (RUMC), Netherlands, Uganda Martyrs Hospital Lubaga, Uganda

Countries where clinical trial is conducted

Tanzania,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary First diagnosis of TB The primary outcome will compare the rate of occurrence of TB disease (defined as definite or probable TB) in treatment and control groups. Definite TB disease will be confirmed by a culture or Xpert positive result for M. tuberculosis. Probable TB will be diagnosed according to an algorithm that takes into account symptoms, chest x-ray reading, sputum smear, histology and verbal autopsy results. Through study completion, median of 33 months follow-up
Secondary Occurrence of possible, probable or definite TB disease At least 24 months post randomisation
Secondary Occurrence of an adverse event From randomisation to 60 days after end of study treatment
Secondary Treatment completion Defined as > 11 of 12 doses of treatment over no more than 16 weeks.
Secondary All-cause mortality At least 24 months post randomisation
Secondary Occurrence of possible, probable, or definite TB, or death Occurrence of possible, probable, or definite TB, or death, noting that a proportion of deaths are likely to be due to TB but not possible to confirm through verbal autopsy and clinical notes review. At least 24 months post randomisation
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A