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

Phase 4

Completed

• Conditions: Latent Tuberculosis Infection
• Interventions: Drug: Preventive treatment with Isoniazid.; Drug: Preventive treatment with Isoniazid

• Registration Number: NCT01223534
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-26
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 871

Inclusion Criteria

• Age ≥18 years.
• Close contact of a pulmonary and/or laryngeal tuberculosis case.
• Written informed consent.

Exclusion Criteria

• HIV infection.
• Immunosuppression other than HIV, such as decompensated liver disease, chronic renal failure, corticosteroids treatment, malignancy under chemotherapy therapy.
• Prior tuberculosis or positive TST.
• Strain resistant to Isoniazid (index case).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A, Standard practice, TST	Preventive treatment with Isoniazid.	Participants allocated to screening as stablished by current practice (TST)
Arm B, Experimental, TST plus QFT-IT	Preventive treatment with Isoniazid	Participants allocated to screening with TST, and if positive, followed by QFT-IT to confirm tuberculosis infection.

Primary Outcome Measures

Name	Time	Method
Development of tuberculosis.	Assessment of primary end-point: 24 months after randomization.

Secondary Outcome Measures

Name	Time	Method
Prescription of treatment.	The day 0 (visit 2) after randomization.

Trial Locations

Locations (1)

Bellvitge University Hospital, IDIBELL; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Barcelona, Spain