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

NCT01223534 | Completed Phase 4 DMC

• 3 other identifiers: QFT-ECC-012009-017430-49TRA-126
• Study Type: interventional
• Target: 871
• Locations: 1 country
• Sites: 1

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.

Conditions

Latent Tuberculosis Infection

Keywords

Tuberculosis; Latent tuberculosis infection; Tuberculin skin test; Interferon-gamma release assays; Contact-tracing study

Outcome Measures

Primary Outcomes (1)

• Development of tuberculosis.

  Assessment of primary end-point: 24 months after randomization.

Secondary Outcomes (1)

• Prescription of treatment.

  The day 0 (visit 2) after randomization.

Study Arms (2)

Arm A, Standard practice, TST

ACTIVE COMPARATOR

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

Drug: Preventive treatment with Isoniazid.

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.

Drug: Preventive treatment with Isoniazid

Interventions

Preventive treatment with Isoniazid DRUG

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

Arm B, Experimental, TST plus QFT-IT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Close contact of a pulmonary and/or laryngeal tuberculosis case.
• Written informed consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Cellestis: collaborator

Study Sites (1)

Bellvitge University Hospital, IDIBELL

L'Hospitalet de Llobregat, Barcelona, Barcelona, 08907, Spain

Location

Related Publications (1)

• 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.

  PMID: 29020191 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Miguel Santin, MD

  Bellvitge University Hospital, Bellvitge Institute for Biomedical Research (IDIBELL)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 27, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)