pedCAPNETZ - Community Acquired Pneumonia (CAP) in Childhood and Adolescence (pedCAPNETZ)

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

Study Overview

• Status: Recruiting
• Conditions: Community-acquired Pneumonia

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Martin Wetzke, Dr. med; Phone Number: 0511-532-3251
• Study Contact Backup: Name: Grit Barten; Phone Number: 0511-532-4434; Email: barten.grit@mh-hannover.de

Study Locations

• Germany
  • Hannover, Germany
    • Recruiting
    • Medizinische Hochschule Hannover
    • Contact: Gesine Hansen, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

CAP patients age < 18

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2014
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: pedCAPNETZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No