Prevention of Tuberculosis in Prisons

NCT03028129 | Terminated Phase 4 Results

• 1 other identifier: U1111-1189-0829
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tuberculosis; Primary prevention; Prisoners; Controlled Clinical Trial; Isoniazid

Outcome Measures

Primary Outcomes (1)

• Quantiferon TB Gold Plus (QIAGEN®) Conversion at the Premature Exclusion Visit.

  Number of participants who had a Quantiferon TB Gold Plus (QIAGEN®) score greater than or equal to 0.35 international units per milliliter, at the time of the premature exclusion visit, on all participants in the group.

  up to 6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Each subject received two oral supervised weekly doses of isoniazid 900 milligrams.

Drug: Isoniazid 900 milligrams

Control

PLACEBO COMPARATOR

Each subject received two oral supervised weekly doses of placebo (oral tablet, without the active ingredient, similar in size, weight, color, taste and odor).

Drug: Placebo

Interventions

Isoniazid 900 milligrams DRUG

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

Also known as: Antibiotic Treatment

Treatment

Placebo DRUG

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

Also known as: Placebo Treatment

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent form.

You may not qualify if:

• Be indigenous;
• Active TB or previous use of isoniazid;
• Score Alcohol Use Disorders Identification Test ≥15.
• Reactive serology for HIV, hepatitis B and C;
• Reactive result for quantiferon, considering as positive the result of Tube 1 and / or Tube22 above 0.2 IU / mL;
• Liver enzymes (Aspartate aminotransferase and Alanate aminotransferase) three times the upper limit;
• History or treatment for epilepsy;

Sponsors & Collaborators

• Federal University of Mato Grosso: lead
• Oswaldo Cruz Foundation: collaborator

Study Sites (1)

Roberto Oliveira

Dourados, Mato Grosso do Sul, 78824210, Brazil

Location

Related Publications (43)

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Related Links

• World Prison Brief: Brazil.
• Power calculator for binary outcome superiority trial.

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Loss to follow-up Interruption of the study Arms presented differential group allocation Statistical power to detect the primary endpoint was 73%, lower than estimated in our sample size calculation

Results Point of Contact

• Title: Julio Croda
• Organization: Federal University of Mato Grosso do Sul

julio.croda@ufms.br

+5567981229959

Study Officials

• Flora MF Moreira, Graduate

  MsC Student

  STUDY CHAIR

• Andrea SS Carbone, MsC

  PhD student

  STUDY CHAIR

• Flavia PC Sacchi, MsC

  PhD student

  STUDY CHAIR

• Paulo CP Santos, Graduate

  MsC Student

  STUDY CHAIR

• Rafaele CP Araújo, MsC

  PhD student

  STUDY CHAIR

• Alessandra C Leite, MsC

  PhD student

  STUDY CHAIR

• Cassia B Reis, PhD

  Pos doc Student

  STUDY CHAIR

• Valeria C Rolla, PhD

  Professor

  STUDY CHAIR

• Jason R Andrews, PhD

  Professor

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: January 23, 2017
• Study Start: September 4, 2017
• Primary Completion: August 10, 2019
• Study Completion: August 10, 2019
• Last Updated: October 25, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)