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

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ClinicalTrials.gov Identifier: NCT04047108
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School

Brief Summary:
Establishment of a study network and patient cohort for pediatric CAP

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: pedCAPNETZ - Development and Detailed Characterization of a Cohort for Community Acquired Pneumonia (CAP) in Childhood and Adolescence
Actual Study Start Date : December 18, 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CAP patients age < 18
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047108


Contacts
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Contact: Martin Wetzke, Dr. med 0511-532-3251
Contact: Grit Barten 0511-532-4434 barten.grit@mh-hannover.de

Locations
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Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Contact: Gesine Hansen, Prof. Dr.         
Sponsors and Collaborators
Hannover Medical School

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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT04047108     History of Changes
Other Study ID Numbers: pedCAPNETZ
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections