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QuantiFERON®-TB Gold In-Tube for the Diagnosis of Tuberculosis Infection in Contact Tracing Study.

NCT01223534 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 871

Last updated 2016-05-27

No results posted yet for this study

Summary

Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB Gold In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study will allow avoiding unnecessary preventive treatment without increasing rates of tuberculosis cases among contacts screened.

Aim of the study: to compare a combined strategy of the TST and the QFT-IT with TST alone for the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing study.

Design and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.

Study population: 870 subjects, household contacts of patients with culture positive pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: Arm A (standard practice), in which treatment decisions will be based on the TST result, and Arm B (experimental), in which treatment decisions will be based on the QFT result.

Interventions: participants in arm A will undergo TST; participants in arm B will undergo TST, and, in case of a positive result, QFT-IT as well. Participants with positive TST (arm A) and positive QFT-IT (arm B) will be diagnosed with tuberculosis infection and will be treated with isoniazid for 6 months. All participants will be followed for two years.

End-points of evaluation: development of tuberculosis and proportion of subjects for whom treatment is prescribed in each arm.

Conditions

  • Latent Tuberculosis Infection

Interventions

DRUG

Preventive treatment with Isoniazid.

If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.

DRUG

Preventive treatment with Isoniazid

If QFT-IT positive, Isoniazid 300 mg/d, for 6 months.

Sponsors & Collaborators

  • Cellestis

    collaborator INDUSTRY

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Miguel Santin, MD · Bellvitge University Hospital, Bellvitge Institute for Biomedical Research (IDIBELL)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Spain

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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 NCT01223534 on ClinicalTrials.gov