PEDIATRIC STUDY

The CAPNETZ study has significantly improved our knowledge of community-acquired pneumonia (CAP) in adults, resulting in improved disease management, diagnosis and treatment. However, the situation is different when it comes to CAP in children and adolescents. Comprehensive, meaningful, and detailed data are still lacking in this area. At the same time, the number of deaths among young patients is particularly high. To address the knowledge gap, the pedCAPNETZ study has been launched, following the example of the CAPNETZ study. A comprehensively characterized cohort will provide urgently needed information on CAP in children and adolescents.

MEANING

pedCAPNETZ: Reducing morbidity and mortality in children and adolescents with community-acquired pneumonia (CAP) through improved management

BACKGROUND

Pneumonia is one of the most common and severe infections in childhood worldwide, accounting for approximately 20% of deaths in the first five years of life. Further, acute respiratory infections are the leading cause of children requiring medical care. Most respiratory infections primarily affect the upper respiratory tract. However, the majority of children also experience a more dangerous lower respiratory tract infection within their first year of life.

Additionally, pneumonia remains one of the most frequent indications for prescribing antibiotics. In the era of increasing antibiotic resistance and considering economic aspects, evidence-based management of CAP in childhood and adolescence is particularly important. However, despite the medical and economic relevance of CAP, the data available at the time of initiating the pedCAPNETZ study was limited. There was a lack of data for Germany and Europe regarding the epidemiology of CAP, disease progression, as well as the spectrum of pathogens and resistance patterns in children. The few existing studies were often conducted on small, often very specific cohorts and therefore had limited significance. Treatment recommendations for children with CAP still primarily relied on studies from the 1980s and 1990s, which had relatively low levels of evidence. The need to improve the data situation was evident, and the motivation was accordingly high.

 

The goals were ambitious. The central motivation of the pedCAPNETZ study was to significantly improve the data foundation on the etiology, epidemiology, and diagnosis of CAP in children and adolescents in developed economies by establishing a sufficiently large cohort of children and adolescents with CAP in Germany. Additionally, relevant insights into risk factors for severe CAP, clinically prognostic markers, biomarkers, as well as the spectrum of causative pathogens were to be gained. The content and organizational structure were modeled after the CAPNETZ study on CAP in adults, which had already proven successful.

CURRENT OBJECTIVES

The knowledge gained from the pedCAPNETZ study aims to reduce CAP-associated morbidity and mortality in childhood and adolescence. The following relevant parameters will be collected in young patients:

  1. Identification of clinical diagnostic criteria.
  2. Collection of comprehensive epidemiological data in Germany.
  3. Analysis of the main risk factors for severe CAP.
  4. Analysis of clinical prognostic markers.
  5. Analysis of biomarkers.
  6. Analysis of the spectrum of pathogens.
  7. Evaluation of clinical and biological markers for differentiating bacterial from viral CAP.

TIMELINE

2014 to 2020

STUDY PARTICIPANTS

A total of 500 children and adolescents with CAP were recruited for the pedCAPNETZ study at eight study sites in Germany. Extensive biomaterials and detailed information on pre-existing conditions, prior medication, CAP therapy, clinical course, complications, and pathogen distribution were collected from the participants over a period of 90 days. These study data, along with the collected biomaterials, are now available for research purposes to address medical questions.

STUDY SITES

  • Department of Pediatric Pulmonology, Allergology, and Neonatology, Hannover Medical School
  • Department of Pediatrics and Adolescent Medicine, University Medical Center Schleswig-Holstein, Campus Lübeck
  • Department of Pediatrics and Adolescent Medicine, Klinikum Oldenburg
  • Department of Pediatrics and Adolescent Medicine, University Hospital Carl Gustav Carus Dresden
  • Center for Pediatrics and Adolescent Medicine, University Medical Center Göttingen
  • Department of General Pediatrics, Neonatology, and Pediatric Cardiology, University Hospital Düsseldorf
  • Pediatric Medical Practice Tuttlingen, Dres. Maier, Mattheß, Röhrenbach
  • Department of Pediatrics and Adolescent Medicine I, University Medical Center Schleswig-Holstein, Campus Kiel

STUDY DESIGN

The pilot phase of the pedCAPNETZ study started in December 2014. Over a period of twelve months, a total of nearly 80 patients aged 0 to 17 years were enrolled in three clinics. The subsequent main project was conducted until December 31, 2020. The pedCAPNETZ study is a prospective, multicenter, longitudinal observational study that includes children and adolescents with symptoms of CAP (community-acquired pneumonia) and the primary inclusion criterion of infiltrates in imaging.

PARTNERS

CAPNETZ Foundation, Hannover Medical School (MHH), DZL-BREATH (Biomedical Research in End-stage and Obstructive Lung Disease Hannover), German Center for Lung Research (DZL), Institute of Virology at the University Medical Center Freiburg, Hannover Unified Biobank (HUB), 2mt Software GmbH.

pedCAPNETZ: VARIOUS ASPECTS OF CAP IN CHILDREN AND ADOLESCENTS

The pedCAPNETZ study has served as a basis for further research projects. Two examples are:

pedCAPNETZ-COVID19 Study:

In 2020, a rapid response was initiated, and the pedCAPNETZ study was expanded with an additional study arm in the face of the COVID-19 pandemic. This strategy allowed for the collection of information on children and adolescents with a hospitalised SARS-CoV-2 infection. The goal of the pedCAPNETZ-COVID19 study was to document 200 patients. The study involved clinics from the pedCAPNETZ study network, and the study implementation was made possible with the support of Novartis.

PAPI Study:

Since 2020, the Pediatric Airway Pathogen Incident (PAPI) study has been conducted during the winter months. It is a comprehensive multicenter observational study on infections caused by RSV (Respiratory Syncytial Virus) and other lower respiratory tract infections in infants and children up to two years old. Current study reports are published weekly at https://papi-studie.de/studiendatenbericht/ . The study involves clinics from the pedCAPNETZ study network as well as pediatric practices in outpatient settings.