NCT01223534

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

Comparison of Two Strategies for Therapeutic Decision-making in Tuberculosis Contact Tracing: a Standard Strategy Based on Tuberculin Skin Test (TST) Alone vs TST Combined With QuantiFERON®-TB Gold In-Tube (QFT-IT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 871 (actual)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2010-10-19
• Last updated: 2016-05-27

Locations

1 site across 1 country: Spain