Trial | NCT01223534  Report issue

Title

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)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    isoniazid ...

  • Study Participants

    871
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.
Study Started
Jul 31
2010
Primary Completion
Feb 29
2016
Study Completion
Feb 29
2016
Last Update
May 27
2016
Estimate

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.

Arm A, Standard practice, TST Active Comparator

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

Arm B, Experimental, TST plus QFT-IT Experimental

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

Criteria 

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).
No Results Posted