Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus (PROTID)
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|ClinicalTrials.gov Identifier: NCT04600167|
Recruitment Status : Not yet recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Tuberculosis||Drug: Isoniazid and Rifapentine (INH-RPT) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Double Blind Placebo Controlled Trial of Rifapentine and Isoniazid for Prevention of Tuberculosis in People With Diabetes|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 2024|
Experimental: Isoniazid and Rifapentine (INH-RPT)
Participants in intervention arm will receive an oral combination of rifapentine (RPT, 900 mg) and isoniazid (INH, 900 mg), once-weekly for 12 weeks.
Drug: Isoniazid and Rifapentine (INH-RPT)
Oral combination of rifapentine (RPT, 900 mg) and isoniazid (INH, 900 mg), once-weekly for 12 weeks.
Other Name: 3HP
Placebo Comparator: Control
Participants in the control arm will receive placebo once weekly for 12 weeks.
Participants in the control group will receive placebo once weekly for 12 weeks
- First diagnosis of TB [ Time Frame: Through study completion, median of 33 months follow-up ]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.
- Occurrence of possible, probable or definite TB disease [ Time Frame: At least 24 months post randomisation ]
- Occurrence of an adverse event [ Time Frame: From randomisation to 60 days after end of study treatment ]
- Treatment completion [ Time Frame: Defined as > 11 of 12 doses of treatment over no more than 16 weeks. ]
- All-cause mortality [ Time Frame: At least 24 months post randomisation ]
- Occurrence of possible, probable, or definite TB, or death [ Time Frame: At least 24 months post randomisation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600167
|Contact: Issa Sabi, MD.||+255 25 250 firstname.lastname@example.org|
|Contact: Nyanda E Ntinginya, MD., MSc., PhD.||+255 25 250 email@example.com|
|Study Chair:||Nyanda E Ntinginya, MD, MSc., Ph.D||Mbeya Medical Research Center, National Institute for Medical Research, Tanzania|
|Principal Investigator:||Nyasatu Chamba, MD.||Kilimanjaro Christian Medical Centre,Moshi,Tanzania|
|Principal Investigator:||Irene Andia- Biraro, MD., Ph.D.||Makerere University, Makerere, Uganda|
|Principal Investigator:||Davis Kibirige, MD, Ph.D.||Martyrs Hospital Lubaga, Makerere, Uganda|