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

NCT ID: NCT01223534

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 871 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2016-02-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A, Standard practice, TST

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

Group Type: ACTIVE_COMPARATOR

Preventive treatment with Isoniazid.

Intervention Type: DRUG

If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.

Arm B, Experimental, TST plus QFT-IT

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

Group Type: EXPERIMENTAL

Preventive treatment with Isoniazid

Intervention Type: DRUG

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

Interventions

Preventive treatment with Isoniazid.

If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.

Intervention Type: DRUG

Preventive treatment with Isoniazid

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

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cellestis

INDUSTRY

Sponsor Role: collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

Miguel Santín Cerezales

PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel Santin, MD

Role: STUDY_DIRECTOR

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

Locations

Bellvitge University Hospital, IDIBELL

L'Hospitalet de Llobregat, Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 29020191 (View on PubMed)

Other Identifiers

2009-017430-49

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TRA-126

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

QFT-ECC-01

Identifier Type: -

Identifier Source: org_study_id