Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus

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

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

Sponsors & Collaborators

• Stichting Katholieke Universiteit- Radboudumc (RUMC), Netherlands

  collaborator UNKNOWN

• Otago University, New Zealand

  collaborator UNKNOWN

• Makerere University

  collaborator OTHER

• St George's, University of London, United Kingdom

  collaborator UNKNOWN

• Kilimanjaro Christian Medical University College (KCMUCo), Tanzania

  collaborator UNKNOWN

• Uganda Martyrs Hospital Lubaga, Uganda

  collaborator UNKNOWN

• King's College London

  collaborator OTHER

• Dr. Nyanda Elias Ntinginya

  lead OTHER_GOV

Principal Investigators

• Nyanda E Ntinginya, MD, MSc., Ph.D · Mbeya Medical Research Center, National Institute for Medical Research, Tanzania

• Nyasatu Chamba, MD. · Kilimanjaro Christian Medical Centre,Moshi,Tanzania

• Irene Andia- Biraro, MD., Ph.D. · Makerere University, Makerere, Uganda

• Davis Kibirige, MD, Ph.D. · Martyrs Hospital Lubaga, Makerere, Uganda

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-17

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Tanzania
• Uganda

Study Locations