Tuberculosis DiseasePOTTERNCT07357844
Pediatric Optimal Tuberculosis Treatment Evaluation and Reassessment
An observational study of Tuberculosis Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Tuberculosis Disease
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Patients under 18 years old, with tuberculosis disease confirmed from patient's clinical file
Who cannot join
- Tuberculosis disease ruled out from patient's clinical file
- Parental opposition or patient opposition (if over 18 years old)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tuberculosis Disease
- Keywords
- Tuberculosis, Children
- Medical subject headings
- Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Tuberculosis treatment outcome
Tuberculosis treatment outcome, per World Health organization definitions: failed, cured, completed, died, lost to follow-up, not evaluated, success
Measured: 2014-2024
Secondary outcomes (7)
Secondary outcomes
Compliance with anti-tuberculosis treatment
Measured: 2024-2026
Secondary outcomes:
Compliance with follow-up consultations
Measured: 2024-2026
Secondary outcomes
Adapted anti-tuberculosis treatment dosage
Measured: 2024-2026
Secondary outcomes
Adverse effects attributed to anti-tuberculosis treatment
Measured: 2024-2026
Secondary outcomes
Microbiological failure
Measured: 2024-2026
Secondary outcomes
Extension of treatment
Measured: 2024-2026
Secondary outcomes
Modification of treatment regimen
Measured: 2024-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start3 Jan 2025
- Primary completion6 Jan 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357844
- Sponsor's protocol ID
- 25-5044
- Acronym
- POTTER
- Status last verified
- Jan 2026
- First submitted
- 15 Jul 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Optimal Tuberculosis Treatment Evaluation and Reassessment
- ClinicalTrials.gov ID
- NCT07357844
- Acronym / sponsor ID
- POTTER / 25-5044
- Conditions
- Tuberculosis Disease
- Keywords
- Tuberculosis, Children
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2014-2024 | – | –Historical group, retrospectively described in 2025 |
| 2025-2026 | – | –Post-structuring of the pediatric infectious diseases' activity group, retrospectively described end of 2026 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Patients under 18 years old, with tuberculosis disease confirmed from patient's clinical file
Key exclusion criteria (2 listed)
- Tuberculosis disease ruled out from patient's clinical file
- Parental opposition or patient opposition (if over 18 years old)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Secondary outcomes
Time frame: 2024-2026
Secondary outcomes:
Time frame: 2024-2026
Secondary outcomes
Time frame: 2024-2026
Secondary outcomes
Time frame: 2024-2026
Secondary outcomes
Time frame: 2024-2026
Secondary outcomes
Time frame: 2024-2026
Secondary outcomes
Time frame: 2024-2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tuberculosis treatment outcome (time frame: 2014-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.