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Active, Not Recruiting

NCT Number: NCT07357844

Pediatric Optimal Tuberculosis Treatment Evaluation and Reassessment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Femme Mère Enfant

Bron, Rhônes, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Secondary outcomes

    Time frame: 2024-2026

    Compliance with anti-tuberculosis treatment

  2. Secondary outcomes:

    Time frame: 2024-2026

    Compliance with follow-up consultations

  3. Secondary outcomes

    Time frame: 2024-2026

    Adapted anti-tuberculosis treatment dosage

  4. Secondary outcomes

    Time frame: 2024-2026

    Adverse effects attributed to anti-tuberculosis treatment

  5. Secondary outcomes

    Time frame: 2024-2026

    Microbiological failure

  6. Secondary outcomes

    Time frame: 2024-2026

    Extension of treatment

  7. Secondary outcomes

    Time frame: 2024-2026

    Modification of treatment regimen

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: POTTER

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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