Severe Pneumonia In Children (S-PIC) Study: A Comparative Effectiveness Study Of Children With Severe Pneumonia In Asia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

931 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-08

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Severe pneumonia is a leading cause of mortality and morbidity in children worldwide. Mortality rates from pediatric severe pneumonia are three times higher in South East Asia compared to the Western hemisphere. The lack of description of epidemiology, current management strategies and outcomes of children with severe pneumonia admitted to pediatric intensive care units (PICUs) in Asia is a barrier to improving pediatric critical care in the region. The lack of a sustainable pediatric critical care network in Asia makes multinational PICU studies challenging.

Through the Pediatric Acute \& Critical Care Medicine Asian Network (PACCMAN), the investigators aim to estimate the burden of pediatric patients admitted to Asian PACCMAN PICUs due to severe pneumonia that develop pediatric acute respiratory distress syndrome. The investigators will characterize etiologies, identify risk factors associated with morbidity and mortality, and develop prognostic prediction models. The investigators hypothesize that there are non-modifiable (e.g., etiological agents) and modifiable risk factors (e.g., steroid therapy and ventilator strategies) that are associated with poor clinical outcomes.

To achieve these aims, the investigators propose a prospective multicenter cohort study over 24 months to recruit 2000 children with severe pneumonia. Pertinent demographic, clinical, microbiological, critical care support and management data will be collected to enable an investigation of the association between risk factors and clinical outcomes in these children. Upon completion of this large observational study, the investigators will have a rich database with detailed information on epidemiology, management strategies and clinical outcomes for severe pneumonia in Asian children.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized Controlled Trial (RCT) in Children With Severe Pneumonia

NCT00455468

Severe Pneumonia

COMPLETED NA

Singapore's Health Outcomes After Critical Illness in Kids

NCT04637113

Pediatric ALL Critical Illness Post Intensive Care Unit Syndrome

COMPLETED

Surviving the Pediatric Intensive Care Unit (PICU)

NCT06812130

Post Intensive Care Syndrome (PICS)

RECRUITING

A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia

NCT04041791

Pneumonia

COMPLETED PHASE3

Diagnosing Pneumonia Under Low-resource Conditions

NCT01997047

Pneumonia Bronchiolitis Asthma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Pediatric Acute \& Critical Care Medicine Asian Network (PACCMAN) is the first pediatric critical care network in Asia. Through this network and this study, the investigators aim to provide a comprehensive epidemiological description, clinical management and outcomes of critically ill children with severe pneumonia across multiple sites in Asia. Through PACCMAN, the investigators aim to collect clinical data across at least 10 countries on children admitted to PICUs for severe pneumonia. Detailed data on aetiologies (not limited to vaccine-preventable pneumonia), broad age groups (not limited to a specific age group of children), and specific and supportive therapies in the PICU, will allow the investigators to perform comparative analysis of important non-modifiable and modifiable risk factors associated with mortality and functional outcomes in a large cohort of children with severe pneumonia. This sets the stage for multi-center studies to investigate the effectiveness of intensive care therapies on the outcomes of children with severe pneumonia.

The overall aim is to study the epidemiology of severe pneumonia is Asian children and compare the effectiveness of currently employed management strategies (related to invasive mechanical ventilation, adjunct and metabolic support) on clinical outcomes in approximately 2000 children with severe pneumonia admitted to PICUs across at least 10 countries in Asia.

The specific aims of this study are as follows:

Primary Aim: To (1) estimate the percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia; (2) estimate the percentage of pediatric patients admitted to PICUs for severe pneumonia that develop pediatric acute respiratory distress syndrome (PARDS) prior to PICU discharge or transfer; (3) estimate the overall and PARDS-specific mortality rates for children admitted for severe pneumonia; (4) characterize/classify etiologies of severe pneumonia according to the WHO criteria.

Secondary Aim 1: Obtain distributions and estimates of 28-day ventilation free days and 28-day PICU free days; estimate the proportion of patients requiring extracorporeal membrane oxygenation.

Secondary Aim 2: Identify risk factors associated with morbidity and mortality rates in children with severe pneumonia in Asia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pediatric patients with severe pneumonia

Pediatric patients admitted to PICU due to severe pneumonia

Data collection

Intervention Type OTHER

Demographic, clinical, microbiological, critical care support and management data will be collected.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Data collection

Demographic, clinical, microbiological, critical care support and management data will be collected.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Children \< 18 years old.
2. Admitted to one of the PICUs in the collaborative network.
3. Evidence of acute infection as defined as reported fever, documented fever or hypothermia, leukocytosis or leucopenia.
4. Evidence of acute respiratory illness as defined as new cough or sputum production, chest pain, dyspnea, tachypnea, abnormal respiratory examination findings or respiratory failure.
5. Radiological evidence of pneumonia within 72 hours before or after admission.

Exclusion Criteria

1. Children with active do-not-resuscitate (DNR) orders
2. Children that have already been enrolled in this study within the previous 28 days
3. Have an alternative diagnosis of a respiratory disorder

Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No