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Prevention of Tuberculosis in Prisons

NCT03028129 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 467

Last updated 2019-10-25

Study results available
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Summary

The purpose of this study is to determine if the isoniazid is effective in the prevention of tuberculosis in a prison population, exposed to the high endemicity of the disease.

Conditions

  • Tuberculosis, Pulmonary
  • Antibiotic Prophylaxis

Interventions

DRUG

Isoniazid 900 milligrams

Oral tablet, with the isoniazid 900mg, given two weekly. The administration will be supervised.

DRUG

Placebo

Oral tablet, without the active ingredient, similar in size, weight, color, taste and odor.

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • Federal University of Mato Grosso

    lead OTHER

Principal Investigators

  • Flora MF Moreira, Graduate · MsC Student

  • Andrea SS Carbone, MsC · PhD student

  • Flavia PC Sacchi, MsC · PhD student

  • Paulo CP Santos, Graduate · MsC Student

  • Rafaele CP Araújo, MsC · PhD student

  • Alessandra C Leite, MsC · PhD student

  • Cassia B Reis, PhD · Pos doc Student

  • Valeria C Rolla, PhD · Professor

  • Jason R Andrews, PhD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-04
Primary Completion
2019-08-10
Completion
2019-08-10

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03028129 on ClinicalTrials.gov