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NCT02073240: EnTIC
Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand
trial testing Enhanced TB IC Package in Tuberculosis in 22 participants. Completed in 18 November 2016.
18 November 2016
Quick facts
| Lead sponsor | Centers for Disease Control and Prevention |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 22 |
| Start date | 17 February 2014 |
| Primary completion | 18 November 2016 |
| Estimated completion | 18 November 2016 |
| Sites | 22 locations across Thailand, Vietnam |
Drugs / interventions tested
- Enhanced TB IC Package
Conditions studied
- Tuberculosis — all drugs for Tuberculosis →
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):
-
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
Verify or expand the search:
- PubMed search for NCT02073240
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02073240 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centers for Disease Control and Prevention
- Last refreshed: 2 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02073240.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing