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

Latent Tuberculosis Infection Clinical Trial

— OPTIMIST  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223534
• Other study ID #: QFT-ECC-01
• Secondary ID: 2009-017430-49TR
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2010
• Last updated: May 26, 2016
• Start date: July 2010
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 871
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Tuberculosis

Intervention

Drug:
• Preventive treatment with Isoniazid.
If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.
• Preventive treatment with Isoniazid
If QFT-IT positive, Isoniazid 300 mg/d, for 6 months.

Locations

Country	Name	City	State
Spain	Bellvitge University Hospital, IDIBELL	L'Hospitalet de Llobregat, Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Cellestis

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of tuberculosis.		Assessment of primary end-point: 24 months after randomization.	No
Secondary	Prescription of treatment.		The day 0 (visit 2) after randomization.	No