NCT04600167

Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus

A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People With Diabetes

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Dr. Nyanda Elias Ntinginya · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Tuberculosis

Interventions

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

Timeline

• Start date: 2022-06-17
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-10-23
• Last updated: 2023-03-29

Locations

4 sites across 2 countries: Tanzania, Uganda