Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus
Status:
Not yet recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Dr. Nyanda Elias Ntinginya
Collaborators:
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