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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04047108
Other study ID # pedCAPNETZ
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 18, 2014
Est. completion date December 31, 2023

Study information

Verified date November 2019
Source Hannover Medical School
Contact Martin Wetzke, Dr. med
Phone 0511-532-3251
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Establishment of a study network and patient cohort for pediatric CAP


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- age < 18

- symptoms of an acute lower respiratory tract infection with radiological confirmed pneumonia via ultrasound or chest x-ray

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Medizinische Hochschule Hannover Hannover

Sponsors (1)

Lead Sponsor Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 5 years
Primary 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
5 years
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