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NCT Number: NCT01223534

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bellvitge University Hospital, IDIBELL

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Preventive treatment with Isoniazid.

Drug

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

Preventive treatment with Isoniazid

Drug

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

Primary outcomes

  1. Development of tuberculosis.

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

Secondary outcomes

  1. Prescription of treatment.

    Time frame: The day 0 (visit 2) after randomization.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

  • Cellestis

Registry information

Official study 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)

Acronym: OPTIMIST

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2010
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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