NCT04047108

Brief Summary

Establishment of a study network and patient cohort for pediatric CAP

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2014

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

9 years

First QC Date

May 16, 2019

Last Update Submit

November 5, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

CAP patients age \< 18

You may qualify if:

  • age \< 18
  • symptoms of an acute lower respiratory tract infection with radiological confirmed pneumonia via ultrasound or chest x-ray

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, Germany

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Central Study Contacts

Martin Wetzke, Dr. med

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

August 6, 2019

Study Start

December 18, 2014

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

November 6, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations