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

Catalan Institute of Health

Status and phase: Completed; Phase 4

Conditions: Latent Tuberculosis Infection

Treatments: Drug: Preventive treatment with Isoniazid.; Drug: Preventive treatment with Isoniazid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01223534

QFT-ECC-01

2009-017430-49 (EudraCT Number)

TRA-126 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 871 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

871 participants in 2 patient groups

Arm A, Standard practice, TST

Active Comparator group

Description:

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

Treatment:

Drug: Preventive treatment with Isoniazid.

Arm B, Experimental, TST plus QFT-IT

Experimental group

Description:

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

Treatment:

Drug: Preventive treatment with Isoniazid