PneumoniaNCT04265287
Severe Pneumonia In Children (S-PIC) Study: A Comparative Effectiveness Study Of Children With Severe Pneumonia In Asia
An observational study of Pneumonia, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Data collection
- How many people
- 931 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Jun 2020to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All PICU admission will be screened daily and those who meet the inclusion criteria will be recruited and consented (if necessary). The investigators will include all patients who are admitted to the PICU including those with oxygen therapy, non-invasive ventilation and invasive mechanical ventilation.
Who may be able to join
- Children < 18 years old.
- Admitted to one of the PICUs in the collaborative network.
- Evidence of acute infection as defined as reported fever, documented fever or hypothermia, leukocytosis or leucopenia.
- Evidence of acute respiratory illness as defined as new cough or sputum production, chest pain, dyspnea, tachypnea, abnormal respiratory examination findings or respiratory failure.
- Radiological evidence of pneumonia within 72 hours before or after admission.
Who cannot join
- Children with active do-not-resuscitate (DNR) orders
- Children that have already been enrolled in this study within the previous 28 days
- Have an alternative diagnosis of a respiratory disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Pneumonia
- Being tested
- Data collection
- Keywords
- severe pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Demographic, clinical, microbiological, critical care support and management data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with severe pneumonia | Pediatric patients admitted to PICU due to severe pneumonia Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia
Estimate the percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia
Measured: Throughout the study, over 24 months
Percentage of pediatric patients admitted to PICUs for severe pneumonia that develop pediatric acute respiratory distress syndrome (PARDS) prior to PICU discharge or transfer
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
Measured: Throughout the study, over 24 months
Overall and PARDS-specific mortality rates for children admitted for severe pneumonia
Estimate the overall and PARDS-specific mortality rates for children admitted for severe pneumonia
Measured: Throughout the study, over 24 months
Characterize/classify etiologies of severe pneumonia in children
Incidence of viral, bacterial and fungal severe pneumonia in children based on microbiological investigations performed as per standard of care.
Measured: Throughout study period, over 24 months
Secondary outcomes (3)
Obtain distributions and estimates of 28-day ventilation free days in patients with severe pneumonia.
Obtain distributions and estimates of 28-day ventilation free days.
Measured: Up to 28 days of mechanical ventilation
Obtain distributions and estimates of 28-day PICU free days.
Obtain distributions and estimates of 28-day PICU free days.
Measured: Up to 28 days of PICU stay
Estimate the proportion of patients severe pneumonia requiring extracorporeal membrane oxygenation.
Total number of patients and proportion of patients with severe pneumonia requiring extracorporeal membrane oxygenation.
Measured: Throughout the study period, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start8 Jun 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 931 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Singapore Clinical Research Institute, Singhealth Foundation
- Responsible party
- Principal investigator, Jan Hau Lee, KK Women's and Children's Hospital
- Investigators
- Jan Hau Lee, Principal investigator, KK Women's and Children's Hospital, SingHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265287
- Sponsor's protocol ID
- S-PIC
- Status last verified
- Jan 2023
- First submitted
- 7 Jan 2020
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong JJM, Abbas Q, Wang JQY, Xu W, Dang H, Phan PH, Guo L, Lee PC, Zhu X, Angurana SK, Pukdeetraipop M, Efar P, Yuliarto S, Choi I, Fan L, Hui AWF, Gan CS, Liu C, Samransamruajkit R, Cho HJ, Ong JSM, Lee JH; Pediatric Acute and Critical Care Asian Network (PACCMAN). Severe Pneumonia in PICU Admissions: The Pediatric Acute and Critical Care Medicine Asian Network (PACCMAN) Observational Cohort Study, 2020-2022. Pediatr Crit Care Med. 2024 Nov 1;25(11):1035-1044. doi: 10.1097/PCC.0000000000003598. Epub 2024 Aug 23.
PubMed 39177431
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Pneumonia In Children (S-PIC) Study: A Comparative Effectiveness Study Of Children With Severe Pneumonia In Asia
- ClinicalTrials.gov ID
- NCT04265287
- Acronym / sponsor ID
- S-PIC
- Conditions
- Pneumonia
- Keywords
- severe pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 931 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Singapore Clinical Research Institute, Singhealth Foundation
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with severe pneumonia | – | Other: Data collectionPediatric patients admitted to PICU due to severe pneumonia |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All PICU admission will be screened daily and those who meet the inclusion criteria will be recruited and consented (if necessary). The investigators will include all patients who are admitted to the PICU including those with oxygen therapy, non-invasive ventilation and invasive mechanical ventilation.
Key inclusion criteria (5 listed)
- Children < 18 years old.
- Admitted to one of the PICUs in the collaborative network.
- Evidence of acute infection as defined as reported fever, documented fever or hypothermia, leukocytosis or leucopenia.
- Evidence of acute respiratory illness as defined as new cough or sputum production, chest pain, dyspnea, tachypnea, abnormal respiratory examination findings or respiratory failure.
- Radiological evidence of pneumonia within 72 hours before or after admission.
Key exclusion criteria (3 listed)
- Children with active do-not-resuscitate (DNR) orders
- Children that have already been enrolled in this study within the previous 28 days
- Have an alternative diagnosis of a respiratory disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionDemographic, clinical, microbiological, critical care support and management data will be collected. | Other | Pediatric patients with severe pneumonia |
Primary outcome
Percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia
Time frame: Throughout the study, over 24 months
Estimate the percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia
Percentage of pediatric patients admitted to PICUs for severe pneumonia that develop pediatric acute respiratory distress syndrome (PARDS) prior to PICU discharge or transfer
Time frame: Throughout the study, over 24 months
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
Overall and PARDS-specific mortality rates for children admitted for severe pneumonia
Time frame: Throughout the study, over 24 months
Estimate the overall and PARDS-specific mortality rates for children admitted for severe pneumonia
Characterize/classify etiologies of severe pneumonia in children
Time frame: Throughout study period, over 24 months
Incidence of viral, bacterial and fungal severe pneumonia in children based on microbiological investigations performed as per standard of care.
3 secondary outcomes
Obtain distributions and estimates of 28-day ventilation free days in patients with severe pneumonia.
Time frame: Up to 28 days of mechanical ventilation
Obtain distributions and estimates of 28-day PICU free days.
Time frame: Up to 28 days of PICU stay
Estimate the proportion of patients severe pneumonia requiring extracorporeal membrane oxygenation.
Time frame: Throughout the study period, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 39177431Wong JJM, Abbas Q, Wang JQY, Xu W, Dang H, Phan PH, Guo L, Lee PC, Zhu X, Angurana SK, Pukdeetraipop M, Efar P, Yuliarto S, Choi I, Fan L, Hui AWF, Gan CS, Liu C, Samransamruajkit R, Cho HJ, Ong JSM, Lee JH; Pediatric Acute and Critical Care Asian Network (PACCMAN). Severe Pneumonia in PICU Admissions: The Pediatric Acute and Critical Care Medicine Asian Network (PACCMAN) Observational Cohort Study, 2020-2022. Pediatr Crit Care Med. 2024 Nov 1;25(11):1035-1044. doi: 10.1097/PCC.0000000000003598. Epub 2024 Aug 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Hau Lee principal investigator
KK Women's and Children's Hospital, SingHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pediatric patients admitted to PACCMAN PICUs due to severe pneumonia (time frame: Throughout the study, over 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.