Clinical trial NCT01223534: QuantiFERON®-TB Gold In-Tube for the Diagnosis of Tuberculosis Infection in Contact Tracing Study.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Latent Tuberculosis Infection
Keywords: Tuberculosis
Latent tuberculosis infection
Tuberculin skin test
Interferon-gamma release assays
Contact-tracing study
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Cellestis
First posted: 2010-10-19
Enrollment: 871
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility 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).

Primary outcomes:
measure: Development of tuberculosis.
timeFrame: Assessment of primary end-point: 24 months after randomization.
Secondary outcomes:
measure: Prescription of treatment.
timeFrame: The day 0 (visit 2) after randomization.
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat, Barcelona
country: Spain
facility: Bellvitge University Hospital, IDIBELL
state: Barcelona
Study officials:
affiliation: Bellvitge University Hospital, Bellvitge Institute for Biomedical Research (IDIBELL)
name: Miguel Santin, MD
role: STUDY_DIRECTOR
References:
citation: Munoz L, Santin M, Alcaide F, Ruiz-Serrano MJ, Gijon P, Bermudez E, Dominguez-Castellano A, Navarro MD, Ramirez E, Perez-Escolano E, Lopez-Prieto MD, Gutierrez-Rodriguez J, Anibarro L, Calvino L, Trigo M, Cifuentes C, Garcia-Gasalla M, Payeras A, Gasch O, Espasa M, Aguero R, Ferrer D, Casas X, Gonzalez-Cuevas A, Garcia-Zamalloa A, Bikuna E, Lecuona M, Galindo R, Ramirez-Lapausa M, Carrillo R; OPTIMIST Study Team. QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial. Clin Infect Dis. 2018 Jan 18;66(3):396-403. doi: 10.1093/cid/cix745.