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NCT02073240: EnTIC

Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand

Completed Last updated 2 February 2021
What this trial tests

trial testing Enhanced TB IC Package in Tuberculosis in 22 participants. Completed in 18 November 2016.

Timeline
17 February 2014
Primary endpoint
18 November 2016
18 November 2016

Quick facts

Lead sponsorCenters for Disease Control and Prevention
StatusCompleted
Study typeOBSERVATIONAL
Enrollment22
Start date17 February 2014
Primary completion18 November 2016
Estimated completion18 November 2016
Sites22 locations across Thailand, Vietnam

Drugs / interventions tested

Conditions studied

Sponsor

Centers for Disease Control and Prevention — full company profile →

Who can join

Adults 18 to 45, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study Design: Stratified, matched, cluster-randomized, controlled trial Unit of Randomization: Healthcare facility Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and disseminated. Study Components: Assessment of institutional safety culture; observations/audits of Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices; documentation of time intervals for processing sputum smears and initiation of TB treatment; facility assessments; random allocation and implementation of enhanced Tuberculosis infection control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months; cost evaluation of intervention. Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per cluster with 50% LTBI prevalence at baseline).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Optimising diagnosis and treatment of tuberculosis infection in community and primary care settings in two urban provinces of Viet Nam: a cohort study.
    Vo LNQ, Nguyen VN, Nguyen NTT, Dong TTT, et al · · 2023 · cited 3× · PMID 36759036 · DOI 10.1136/bmjopen-2022-071537

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Other recruiting trials for Tuberculosis

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing