PAPI STUDY

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MEANING

Pediatric Airway Pathogen Incidence

BACKGROUND

Lower airway infection is a frequent disease among children and associated to increased morbidity and mortality especially in neonates and toddlers. One of the most common pathogens is the Respiratory Syncytial Virus (RSV) followed by the Human Metapneumovirus, Rhinovirus, Influenza and more recently, SARS-CoV-2. Currently, no targeted therapy against RSV and other viral respiratory pathogens exists for children and neonates. A preventative therapy against RSV consists of the monoclonal antibody Palivizumab.

By proving a systematic documentation of pathogens and associated disease phenotypes as well as courses of treatment this study intends to contribute to improved therapy and prevention strategies for airway infections in children. Also complications, exacerbations and sequelae such as pneumonia shall be described, and put into context with socioeconomic factors that contribute to disease occurrence.

STUDY OBJECTIVES

  1. Description of common viral pathogens that cause severe airway infection in children and neonates
  2. Description of courses of disease of these infections in context of pre-existing medical conditions, with special interest in RSV as a pathogen
  3. Description of demographic and socioeconomic factors contributing to the burden of the disease on the family and the healthcare system

TIMEFRAME

  • Three seasons of RSV (September/October to April) starting 2020/21
  • Observational timeframe per patient: 28 days

PATIENT PROFILE

Children (0-2 years) which are hospitalized or under ambulatory treatment due to respiratory infection. A total of around 1900 patient will be recruited

STUDY LOCATIONS

12 pediatric clinics and 4 pediatric practitioner’s offices in Germany

METHODOLOGY

Prospective multi-central observational study

ROLE OF CAPNETZ: IMPLEMENTATION OF THE STUDY PROJECT

The CAPNETZ STIFTUNG headquarters executes the study in close collaboration with the department of pediatric pulmonology, allergology and neonatal medicine at the Medical School Hannover (MHH).  The study was inspired by an acute need to investigate open questions on respiratory infection in toddlers.

Project- and data management tasks performed by CAPNETZ STIFTUNG are pivotal to the project which is fully implemented by CAPNETZ. CAPNETZ provides research infrastructure which was established 2015 for the pedCAPNETZ study on community-acquired pneumonia in children and extended with additional clinical centres. Patient recruitment and data collection are coordinated between the CAPNETZ STIFTUNG headquarters and participating clinical centres. Pathogen identification is conducted centrally at the Institute of Virology of the University Clinic Freiburg. Scientific lead is MHH pediatrician Dr Martin Wetzke. The PAPI study receives financial support from Sanofi-Pasteur as industrial partner.

The PAPI study publishes weekly updates on pathogen distributions and RSV incidence in Germany at www.papi-studie.de