Community-acquired PneumoniapedCAPNETZNCT04047108
pedCAPNETZ - Community Acquired Pneumonia (CAP) in Childhood and Adolescence
An observational study of Community-acquired Pneumonia, run by Hannover Medical School at 1 site in Germany.
Trial summary
Establishment of a study network and patient cohort for pediatric CAP Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Community-acquired Pneumonia
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 18 Dec 2014to 31 Dec 2023
- How long will I take part?
- 3 Months
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: CAP patients age < 18
Who may be able to join
- age < 18
- symptoms of an acute lower respiratory tract infection with radiological confirmed pneumonia via ultrasound or chest x-ray
Who cannot join
- hospitalization for any reason within the last 28 days
- congenital or acquired immunodeficiency
- concomitant respiratory disease with impaired mucociliary clearance such as cystic fibrosis, primary ciliary dyskinesia, tracheostomy or other severe lung disease including pulmonary tuberculosis, malignancy, and cytostatic therapy during past 28 days or neutropenia (< 1000/µl) or relevant immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
Martin Wetzke, Dr. med contact
Germany1 site, 1 recruiting
- Recruiting
Medizinische Hochschule Hannover
Hanover
Gesine Hansen, Prof. Dr.
About this study
Official title: pedCAPNETZ - Development and Detailed Characterization of a Cohort for Community Acquired Pneumonia (CAP) in Childhood and Adolescence
Establishment of a study network and patient cohort for pediatric CAP
Read the detailed description
The aim of the project is the development of a large pediatric CAP patient cohort based on the established pedCAPNETZ pilot cohort. The main objective is to improve knowledge on etiology, epidemiology, diagnosis and management of pediatric CAP in a developed country. pedCAPNETZ will enable the systematic and detailed characterization of pediatric CAP cases on an epidemiological, clinical and biological level.
- Conditions
- Community-acquired Pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with pediatric community acquired pneumonia (pedCAP) across all different levels of health care
To establish a multicenter national, prospective, observational and longitudinal pedCAP database and collaborative research network
Measured: 5 years
Prevalence of pedCAP and etiologies (composite outcome measures) across all different levels of health care
- Etiology of pedCAP in Germany
- Clinical presentation of pedCAP
- Predictors of severe clinical course of pedCAP
- Diagnostics employed in management of pedCAP
- Microbiology and virology of pedCAP
- Radiology of pedCAP
- Comorbidity in patients with pedCAP
- Treatment patterns of pedCAP
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start18 Dec 2014
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047108
- Sponsor's protocol ID
- pedCAPNETZ
- Acronym
- pedCAPNETZ
- Status last verified
- Nov 2019
- First submitted
- 16 May 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- pedCAPNETZ - Development and Detailed Characterization of a Cohort for Community Acquired Pneumonia (CAP) in Childhood and Adolescence
- ClinicalTrials.gov ID
- NCT04047108
- Acronym / sponsor ID
- pedCAPNETZ / pedCAPNETZ
- Conditions
- Community-acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 18 Dec 2014 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Aug 2019 (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.
Establishment of a study network and patient cohort for pediatric CAP
Detailed description
The aim of the project is the development of a large pediatric CAP patient cohort based on the established pedCAPNETZ pilot cohort. The main objective is to improve knowledge on etiology, epidemiology, diagnosis and management of pediatric CAP in a developed country. pedCAPNETZ will enable the systematic and detailed characterization of pediatric CAP cases on an epidemiological, clinical and biological level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- CAP patients age < 18
Key inclusion criteria (2 listed)
- age < 18
- symptoms of an acute lower respiratory tract infection with radiological confirmed pneumonia via ultrasound or chest x-ray
Key exclusion criteria (3 listed)
- hospitalization for any reason within the last 28 days
- congenital or acquired immunodeficiency
- concomitant respiratory disease with impaired mucociliary clearance such as cystic fibrosis, primary ciliary dyskinesia, tracheostomy or other severe lung disease including pulmonary tuberculosis, malignancy, and cytostatic therapy during past 28 days or neutropenia (< 1000/µl) or relevant immunosuppressive treatment
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
Number of patients with pediatric community acquired pneumonia (pedCAP) across all different levels of health care
Time frame: 5 years
To establish a multicenter national, prospective, observational and longitudinal pedCAP database and collaborative research network
Prevalence of pedCAP and etiologies (composite outcome measures) across all different levels of health care
Time frame: 5 years
* Etiology of pedCAP in Germany * Clinical presentation of pedCAP * Predictors of severe clinical course of pedCAP * Diagnostics employed in management of pedCAP * Microbiology and virology of pedCAP * Radiology of pedCAP * Comorbidity in patients with pedCAP * Treatment patterns of pedCAP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Martin Wetzke, Dr. med contact
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 Community-acquired Pneumonia, run by Hannover Medical School at 1 site in Germany.
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 2 inclusion and 3 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 6 Nov 2019. 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 Germany. 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 Martin Wetzke, Dr. med (0511-532-3251), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with pediatric community acquired pneumonia (pedCAP) across all different levels of health care (time frame: 5 years). The study lists 2 primary outcomes in all. 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 6 Nov 2019.