Pediatric Optimal Tuberculosis Treatment Evaluation and Reassessment (POTTER)

January 13, 2026 updated by: Hospices Civils de Lyon

The treatment of tuberculosis disease in children benefits from clear and up-to-date recommendations from the World Health organization. The research issues supported by the WHO mainly concern tuberculosis treatment implementation in areas of high incidence and low economic level. Pediatric cohorts in countries with high economic levels are rare, making it impossible to quantify and describe deviations from optimal recommendations. The French recommendations are mainly focused on screening cases of tuberculosis, without specific guidelines for care organization and recent practice evaluation.

The retrospective study of patients followed by the pediatric infectious disease team of the Hospices Civils de Lyon (HCL) would allow to quantify treatment successes and failures, and to describe these failures in a French pediatric tertiary care center. This retrospective analysis is part of an evolution of the pediatric infectious diseases' activity of HCL in 2024: structuring of the service with a full-time practitioner, establishment of multi-professional care with the involvement of psychologists and clinical pharmacists. This retrospective study will help to understand the causes of failure in French tertiary pediatric centers and to describe the expected benefits of a structured and multi-professional care to improve the treatment of pediatric tuberculosis diseases in France.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhônes
      • Bron, Rhônes, France, 69500
        • Hôpital Femme Mère Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged 0-18 years treated and followed-up in Hospices Civils de Lyon from 2014 to 2026 by the pediatric infectious diseases team for tuberculosis disease.

Hospices Civils de Lyon is the sole pediatric tertiary care center and pediatric infectious diseases ward in the county.

Description

Inclusion Criteria :

- Patients under 18 years old, with tuberculosis disease confirmed from patient's clinical file

Exclusion Criteria :

  • Tuberculosis disease ruled out from patient's clinical file
  • Parental opposition or patient opposition (if over 18 years old)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
2014-2024
Historical group, retrospectively described in 2025
2025-2026
Post-structuring of the pediatric infectious diseases' activity group, retrospectively described end of 2026

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tuberculosis treatment outcome
Time Frame: 2014-2024
Tuberculosis treatment outcome, per World Health organization definitions: failed, cured, completed, died, lost to follow-up, not evaluated, success
2014-2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcomes
Time Frame: 2024-2026
Compliance with anti-tuberculosis treatment
2024-2026
Secondary outcomes:
Time Frame: 2024-2026
Compliance with follow-up consultations
2024-2026
Secondary outcomes
Time Frame: 2024-2026
Adapted anti-tuberculosis treatment dosage
2024-2026
Secondary outcomes
Time Frame: 2024-2026
Adverse effects attributed to anti-tuberculosis treatment
2024-2026
Secondary outcomes
Time Frame: 2024-2026
Microbiological failure
2024-2026
Secondary outcomes
Time Frame: 2024-2026
Extension of treatment
2024-2026
Secondary outcomes
Time Frame: 2024-2026
Modification of treatment regimen
2024-2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2025

Primary Completion (Actual)

January 6, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 15, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-5044

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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