NCT00397709

Brief Summary

The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months(isoniazid plus rifampin)group I, with the standard course for 6 months(isoniazid)group II .Prospective, comparative, randomized and open trial of patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV infection. 105 patients were included. In Conclusion, a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H. Tolerance is similar in the two courses.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 1996

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1996

Completed
9.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
Last Updated

December 31, 2008

Status Verified

November 1, 2006

First QC Date

November 7, 2006

Last Update Submit

December 30, 2008

Conditions

Keywords

Latent tuberculosis infection.Isoniazid.Rifampin.Clinical trial.treatment of latent tuberculosis infection

Outcome Measures

Primary Outcomes (2)

  • to compare the compliance

  • to compare the side effects

Secondary Outcomes (1)

  • Development of tuberculosis

Interventions

Eligibility Criteria

Age16 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC:

You may not qualify if:

  • HIV infection.
  • Hepatopathy
  • Previous treatment of of latent tuberculosis infection.
  • Allergy to drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Paloma Geijo Martinez. Hospital Virgen de la Luz

Cuenca, Cuenca, 16002, Spain

Location

Related Publications (1)

  • Geijo MP, Herranz CR, Vano D, Garcia AJ, Garcia M, Dimas JF. [Short-course isoniazid and rifampin compared with isoniazid for latent tuberculosis infection: a randomized clinical trial]. Enferm Infecc Microbiol Clin. 2007 May;25(5):300-4. doi: 10.1157/13102264. Spanish.

Related Links

MeSH Terms

Conditions

TuberculosisLatent Tuberculosis

Interventions

IsoniazidRifampin

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Maria Paloma Geijo Martinez, MD

    Unidad MI-Infecciosas. Hospital Virgen de la Luz. Cuenca 16002 Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 9, 2006

Study Start

March 1, 1996

Study Completion

February 1, 2006

Last Updated

December 31, 2008

Record last verified: 2006-11

Locations