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

Primary Purpose

Latent Tuberculosis Infection

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Preventive treatment with Isoniazid.
Preventive treatment with Isoniazid
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Latent Tuberculosis Infection focused on measuring Tuberculosis, Latent tuberculosis infection, Tuberculin skin test, Interferon-gamma release assays, Contact-tracing study

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Bellvitge University Hospital, IDIBELL

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A, Standard practice, TST

Arm B, Experimental, TST plus QFT-IT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Development of tuberculosis.

Secondary Outcome Measures

Prescription of treatment.

Full Information

First Posted
October 18, 2010
Last Updated
May 26, 2016
Sponsor
Hospital Universitari de Bellvitge
Collaborators
Cellestis
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1. Study Identification

Unique Protocol Identification Number
NCT01223534
Brief Title
QuantiFERON®-TB Gold In-Tube for the Diagnosis of Tuberculosis Infection in Contact Tracing Study.
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
Collaborators
Cellestis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis Infection
Keywords
Tuberculosis, Latent tuberculosis infection, Tuberculin skin test, Interferon-gamma release assays, Contact-tracing study

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
871 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A, Standard practice, TST
Arm Type
Active Comparator
Arm Description
Participants allocated to screening as stablished by current practice (TST)
Arm Title
Arm B, Experimental, TST plus QFT-IT
Arm Type
Experimental
Arm Description
Participants allocated to screening with TST, and if positive, followed by QFT-IT to confirm tuberculosis infection.
Intervention Type
Drug
Intervention Name(s)
Preventive treatment with Isoniazid.
Intervention Description
If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.
Intervention Type
Drug
Intervention Name(s)
Preventive treatment with Isoniazid
Intervention Description
If QFT-IT positive, Isoniazid 300 mg/d, for 6 months.
Primary Outcome Measure Information:
Title
Development of tuberculosis.
Time Frame
Assessment of primary end-point: 24 months after randomization.
Secondary Outcome Measure Information:
Title
Prescription of treatment.
Time Frame
The day 0 (visit 2) after randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Santin, MD
Organizational Affiliation
Bellvitge University Hospital, Bellvitge Institute for Biomedical Research (IDIBELL)
Official's Role
Study Director
Facility Information:
Facility Name
Bellvitge University Hospital, IDIBELL
City
L'Hospitalet de Llobregat, Barcelona
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29020191
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. Erratum In: Clin Infect Dis. 2018 Aug 31;67(6):987.
Results Reference
derived

Learn more about this trial

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

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