Pulmonary TuberculosisTPENCT06110533
Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals
An observational study of Pulmonary Tuberculosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pulmonary Tuberculosis
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2023to 14 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Child (1 to 17 years old) hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.
Who may be able to join
- Child (1 to 17 years old)
- Child hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.
- Child and/or his/her parental authority who have not expressed their opposition to the reuse of data for scientific research purposes.
Who cannot join
- Subject and/or their parental authority having expressed their opposition to the re-use of the child's data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France
Strasbourg, 67091
Laurence WEISS, MD, 33 3 88 12 83 95, laurence.weiss@chru-strasbourg.fr
Laurence WEISS, MD
About this study
Official title: Descriptive Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals
Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. In 2020, there were approximately 1.0 million new cases of pulmonary tuberculosis among children worldwide.
In France, childhood tuberculosis remains a rare disease; the most recent data show a rate of 3.3 cases per 100,000 inhabitants among children under 15 years old in 2019.
Read more
Pulmonary tuberculosis in children can lead to complications such as bronchiectasis and pneumothorax. Children living in homes where an adult has a active tuberculosis, or children with diseases chronic, malnourished or suffering from HIV are more likely to contract tuberculosis.
The aim of this research is to determine the incidence, identify the risk factors as well as the clinical forms of pulmonary tuberculosis in children hospitalized at Strasbourg University Hospitals between 2012 and 2022.
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Pulmonary tuberculosis, Tuberculosis in children, Childhood tuberculosis, Mycobacterium tuberculosis
- Medical subject headings
- Tuberculosis, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and risk factors for pulmonary tuberculosis in children hospitalized at Strasbourg University Hospital between 2012 and 2022
Measured: 1 month after hospitalization for pulmonary tuberculosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start4 Apr 2023
- Primary completionApr 2024 (estimated)
- Study completion14 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110533
- Sponsor's protocol ID
- 8907
- Acronym
- TPE
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- 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 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals
- ClinicalTrials.gov ID
- NCT06110533
- Acronym / sponsor ID
- TPE / 8907
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Pulmonary tuberculosis, Tuberculosis in children, Childhood tuberculosis, Mycobacterium tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- 14 Apr 2024 (estimated)
- First posted
- 31 Oct 2023 (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.
Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. In 2020, there were approximately 1.0 million new cases of pulmonary tuberculosis among children worldwide.
In France, childhood tuberculosis remains a rare disease; the most recent data show a rate of 3.3 cases per 100,000 inhabitants among children under 15 years old in 2019.
Pulmonary tuberculosis in children can lead to complications such as bronchiectasis and pneumothorax. Children living in homes where an adult has a active tuberculosis, or children with diseases chronic, malnourished or suffering from HIV are more likely to contract tuberculosis.
The aim of this research is to determine the incidence, identify the risk factors as well as the clinical forms of pulmonary tuberculosis in children hospitalized at Strasbourg University Hospitals between 2012 and 2022.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child (1 to 17 years old) hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.
Key inclusion criteria (3 listed)
- Child (1 to 17 years old)
- Child hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.
- Child and/or his/her parental authority who have not expressed their opposition to the reuse of data for scientific research purposes.
Key exclusion criteria (1 listed)
- Subject and/or their parental authority having expressed their opposition to the re-use of the child's data for scientific research purposes.
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
Incidence and risk factors for pulmonary tuberculosis in children hospitalized at Strasbourg University Hospital between 2012 and 2022
Time frame: 1 month after hospitalization for pulmonary tuberculosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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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.
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 Pulmonary Tuberculosis, run by University Hospital, Strasbourg, France 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence WEISS, MD (33 3 88 12 83 95, laurence.weiss@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and risk factors for pulmonary tuberculosis in children hospitalized at Strasbourg University Hospital between 2012 and 2022 (time frame: 1 month after hospitalization for pulmonary tuberculosis). 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 31 Oct 2023.