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

Sponsor

Hospital Universitari de Bellvitge (Other)

Overall Status

Completed

CT.gov ID

NCT01223534

Collaborator

Cellestis (Industry)

871

Enrollment

Location

Arms

67.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

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.

Condition or Disease	Intervention/Treatment	Phase
Latent Tuberculosis Infection	Drug: Preventive treatment with Isoniazid. Drug: Preventive treatment with Isoniazid	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

871 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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)

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A, Standard practice, TST Participants allocated to screening as stablished by current practice (TST)	Drug: Preventive treatment with Isoniazid. If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.
Experimental: Arm B, Experimental, TST plus QFT-IT Participants allocated to screening with TST, and if positive, followed by QFT-IT to confirm tuberculosis infection.	Drug: Preventive treatment with Isoniazid If QFT-IT positive, Isoniazid 300 mg/d, for 6 months.

Arm

Intervention/Treatment

Active Comparator: Arm A, Standard practice, TST

Participants allocated to screening as stablished by current practice (TST)

Drug: Preventive treatment with Isoniazid.

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

Experimental: Arm B, Experimental, TST plus QFT-IT

Participants allocated to screening with TST, and if positive, followed by QFT-IT to confirm tuberculosis infection.

Drug: Preventive treatment with Isoniazid

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

Outcome Measures

Primary Outcome Measures

Development of tuberculosis. [Assessment of primary end-point: 24 months after randomization.]

Secondary Outcome Measures

Prescription of treatment. [The day 0 (visit 2) after randomization.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).