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Starting soon Not applicable

Hospital and Extra-hospital Nursing Care for Tuberculosis

NCT06696053 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-09
Last updated
2026-04-24

Condition(s) studied

Tuberculosis

Investigational drug(s) / intervention(s)

Transversal therapeutic education

Transversal therapeutic education: Additional patient consultation for therapeutic education with nurses.

Study summary

The incidence of tuberculosis has decreased over the last 2 years on the national territory (6.4/100,000 inhabitants) but remains twice as high in Ile de France where it is increasing with an increase of almost 10% in the number of cases. reported between 2015 and 2017 . the notification rate of tuberculosis disease for the year 2020 was 14.3 cases per 100,000 inhabitants (i.e. 1757 cases declared) which is more than double that found at the national level . As the disease is multifocal, patients are likely to be hospitalized in different departments with variable care and compliance support offered. One of the major issues is compliance with treatment. Indeed, INVS data (2008-2014) report a percentage of treatment completed in pulmonary tuberculosis of 73% . Among these cases, 20% had a potentially unfavorable outcome, including 45% lost to follow-up, which creates a risk of relapse and contagiousness for those around them. The latest data reported in 2022 over the period 2014-2018 seem to show an increase in treatment completeness but completeness remains variable from one region to another and from one year to another Using Public Health France data, the investigator were able to collect the proportion of completeness of treatment at Saint Antoine hospital, which is 60% over the period 2014-2016 (Public Health France, unpublished data). In more recent work carried out within the department retrospectively between 2019-2021, the investigator compared treatment outcomes depending on whether or not patients benefit from ETP support and it is 66% among patients without it. benefited, thus confirming the data from Public Health France over a more recent period.. In this context, several other studies have shown the interest of a therapeutic education program on the completeness of the treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient for whom a diagnosis of tuberculosis disease or latent tuberculosis according to the recommendations of the IDSA / CDC has been made and treatment with antituberculosis drugs started less than 3 weeks ago (9) * Patient followed in one of the participating departments of the St Antoine hospital (internal medicine, rheumatology, gastroenterology, hepatology, geriatrics) * Patient having signed informed consent * Patient whose age \> 18 years * Patient affiliated to a social security scheme Exclusion Criteria: * Patient under legal protection

Primary outcome measure(s)

  • Rate of outcomes of completed antituberculosis treatment — At 6, 9 and 12 month post inclusion
    A favorable treatment outcome will be defined by a composite criterion, namely: treatment compliance \> 80% (self-questionnaire during visits), 80% of visits honored and clinical cure for the referring physician.

Trial sites (1)

FacilityCityRegionStatus
Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Antoine Paris Paris
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06696053 on ClinicalTrials.gov ↗ ← All trials in France