PneumoniaPEER-PePPesNCT03366454

Implementing a Combination of Clinical Parameters, Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients

An observational study of Pneumonia, run by INA-RESPOND Secretariat at 4 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Participants who meet the inclusion and exclusion criteria will be enrolled and then having a daily follow up for maximum of 13 days' hospitalization. Next follow up will be taken time at day 14th after hospitalization date, either on ward or policlinic. Read more about this study

Who is it for?: Ages 2 months to 5 years
Conditions the study is for: Pneumonia
How many people: 188 participants
Where: 4 sitesIndonesia
Study dates: 4 Jul 2017to 31 Dec 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 months to 5 years
All sexes
No healthy volunteers
Child

Study population: Hospitalized patients with pneumonia whose ages range from 2 months to 5 years. This is a preliminary study to characterize the pathogens present in this cohort. The number of participants' that will be enrolled is based on the number of pneumonia cases in 5 years old children or less, which is approximately 100 patients per year in each hospital. Estimating that 50% of them failed to satisfy the inclusion and exclusion criteria, this study plan to enroll 50 participants per site per year, or a total of 275 participants.

Who may be able to join

Pediatric inpatients whose ages range from 2 months to 5 years
Meet the case definition for pneumonia which is cough or fever with at least one other following symptoms:
Shortness of breath
Tachypnea
Grunting
Crackles/rhonchi

Show all 10Show fewer

Decreased vesicular breath sound
Bronchial breath sound
Chest x-ray consistent with pneumonia
Comply with all study procedures including to store required specimens for diagnostic testing and archiving.

Who cannot join

Being Hospitalized for more than 24 hours at enrollment
Having a cancer or history of cancer
Having a history of long term exposed of steroid (at the minimum of 2 months)
Having any condition that might interfere with study procedure and compliance (based on clinicians' judgement)

Trial locations and contacts

4 sites in 1 country.

Indonesia4 sites

University of Diponegoro/ Dr. Kariadi Hospital
Semarang, Central Java, 50244
RSU Kabupaten Tangerang
Tangerang, West Java, 15111
An-Nisa Hospital
Tangerang, West Java, 15132
University of Gadjah Mada/ Dr. Sardjito Hospital
Yogyakarta, DIY Yogyakarta, 55284

Other trials in Indonesia

About this study

Official title: Implementing a Combination of Clinical Parameters (Rapid Diagnostic Tests (RDTs), Biomarkers, and Standard of Care Procedures (SoCs) for the Etiology Diagnoses of Pneumonia in Pediatric Patients to Improve Clinical Management in Indonesia.

Read the detailed description

This study will collect demographic data, medical history, clinical data, treatment, and risk factors of pneumonia. The study also record the supporting examination results include but not limited to Complete Blood Count (CBC) results, blood gas analyses result, CRP, PCT, culture result, rapid test for influenza, Respiratory Syncytial Virus (RSV), legionella, and chest X-ray. In order to produce a robust data, this study will conduct the serological and molecular tests at the reference laboratory.

Whole blood, serum, urine, Nasal Pharyngeal Swab (NPS), sputum/induced sputum, and other respiratory specimens (if available) will be collected for storage and testing at enrollment. Plasma from 48-72 hours after hospitalization and left-over respiratory specimens on day 2 and 3 of hospitalization will also be collected to be stored. For additional, at day 14th after hospitalization serum will be processed from 4 mL of blood for archiving and testing at the reference laboratory.

This study will be conducted at following INA-RESPOND sites:

RSU Kabupaten Tangerang, Tangerang
RSUP Dr. Kariadi, Semarang
RSUP Dr. Sardjito, Yogyakarta RSU Kabupaten Tangerang located in Banten province is type B or district referral hospital. While RSUP Dr Kariadi in Semarang and RSUP Dr Sardjito in Yogyakarta are type A hospital which is a level of province referral. Maximum duration for participants' accrual will be 2 years since the first participant enrolled. However, the study laboratory testing may take up to 6 months to be completed.

Conditions: Pneumonia
Medical subject headings: Pneumonia

What is being measured

The primary outcome is the main question the study is designed to answer.

White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
The area under the receiver operating curve (AUROC) for WBC and ANC count at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Measured: Total length of time the subject will be in the study is one month after enrollment.
Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
The area under the receiver operating curve (AUROC) for NLR at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Measured: Total length of time the subject will be in the study is one month after enrollment.
CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
The area under the receiver operating curve (AUROC) for CRP at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Measured: Total length of time the subject will be in the study is one month after enrollment.
Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
The area under the receiver operating curve (AUROC) for PCT at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Measured: Total length of time the subject will be in the study is one month after enrollment.

Secondary outcomes (5)

The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects.
Any pathogens identified as a cause of pneumonia based on laboratory tests such as culture, serology, and molecular assays.
Measured: Total length of time the subject will be in the study is one month after enrollment.
The Clinical Outcome in Pneumonia Pediatric Subjects
Data and specimens were collected at enrollment and 14 days after enrollment. A telephone interview was done on day 30 to assess the clinical outcome. The outcome report was expressed in percentages of enrolled subjects and the proportions of subjects within each category defined by cured and death.
Measured: Total length of time the subject will be in the study is one month after enrollment.
The Percentage of Sign and Symptom of SoC Procedure
The percentage of sign and symptom of SoC procedure of pneumonia pediatric subjects expressed in percentages of identified pathogens. The proportion of subjects within each category is defined by bacterial or mixed infections and viral infections. We analyzed only 155 subjects with confirmed etiology for this secondary outcome.
Measured: Total length of time the subject will be in the study is one month after enrollment.
Performance of Combined Factors in Differentiating Viral and Bacterial Infections
We explored the combination of significant factors/variables in the multivariate analysis for their overall sensitivity and specificity for discriminating bacterial/mixed and viral infection. The combination variables were CRP ≥5.70 mg/L + fever, CRP ≥5.70 mg/L + dry season, and CRP ≥5.70 mg/L + fever + dry season.
For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Measured: Total length of time the subject will be in the study is one month after enrollment.
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Any pathogens identified as a cause of pneumonia based on laboratory tests such as culture, serology, and molecular assays. We analyzed only 155 subjects with confirmed etiology for this secondary outcome.
Measured: Total length of time the subject will be in the study is one month after enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jul 201731 Dec 2019

First posted8 Dec 2017
Study start4 Jul 2017
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03366454
Sponsor's protocol ID: INA201
Other IDs: U1111-1263-2368
Acronym: PEER-PePPes
Status last verified: May 2025
First submitted: 8 Nov 2017
Last updated: 4 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lokida D, Farida H, Triasih R, Mardian Y, Kosasih H, Naysilla AM, Budiman A, Hayuningsih C, Anam MS, Wastoro D, Mujahidah M, Dipayana S, Setyati A, Aman AT, Lukman N, Karyana M, Kline A, Neal A, Lau CY, Lane C. Epidemiology of community-acquired pneumonia among hospitalised children in Indonesia: a multicentre, prospective study. BMJ Open. 2022 Jun 21;12(6):e057957. doi: 10.1136/bmjopen-2021-057957.
PubMed 35728910

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing a Combination of Clinical Parameters (Rapid Diagnostic Tests (RDTs), Biomarkers, and Standard of Care Procedures (SoCs) for the Etiology Diagnoses of Pneumonia in Pediatric Patients to Improve Clinical Management in Indonesia.
ClinicalTrials.gov ID: NCT03366454
Acronym / sponsor ID: PEER-PePPes / INA201
Conditions: Pneumonia
Study type: Observational
Recruitment status: Completed
Enrolment: 188 participants (actual)
Lead sponsor: INA-RESPOND SecretariatUniversity, hospital or other
Collaborators: United States Agency for International Development (USAID), Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
Study start: 4 Jul 2017 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 8 Dec 2017 (actual)
Results: Posted 4 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will be conducted at following INA-RESPOND sites:

RSU Kabupaten Tangerang, Tangerang
RSUP Dr. Kariadi, Semarang
RSUP Dr. Sardjito, Yogyakarta RSU Kabupaten Tangerang located in Banten province is type B or district referral hospital. While RSUP Dr Kariadi in Semarang and RSUP Dr Sardjito in Yogyakarta are type A hospital which is a level of province referral. Maximum duration for participants' accrual will be 2 years since the first participant enrolled. However, the study laboratory testing may take up to 6 months to be completed.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 2 months to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Hospitalized patients with pneumonia whose ages range from 2 months to 5 years. This is a preliminary study to characterize the pathogens present in this cohort. The number of participants' that will be enrolled is based on the number of pneumonia cases in 5 years old children or less, which is approximately 100 patients per year in each hospital. Estimating that 50% of them failed to satisfy the inclusion and exclusion criteria, this study plan to enroll 50 participants per site per year, or a total of 275 participants.

Key inclusion criteria (10 listed)

Pediatric inpatients whose ages range from 2 months to 5 years
Meet the case definition for pneumonia which is cough or fever with at least one other following symptoms:
Comply with all study procedures including to store required specimens for diagnostic testing and archiving.

Key exclusion criteria (4 listed)

Being Hospitalized for more than 24 hours at enrollment
Having a cancer or history of cancer
Having a history of long term exposed of steroid (at the minimum of 2 months)
Having any condition that might interfere with study procedure and compliance (based on clinicians' judgement)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens
Time frame: Total length of time the subject will be in the study is one month after enrollment.
The area under the receiver operating curve (AUROC) for WBC and ANC count at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
Time frame: Total length of time the subject will be in the study is one month after enrollment.
The area under the receiver operating curve (AUROC) for NLR at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
Time frame: Total length of time the subject will be in the study is one month after enrollment.
The area under the receiver operating curve (AUROC) for CRP at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.
Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens
Time frame: Total length of time the subject will be in the study is one month after enrollment.
The area under the receiver operating curve (AUROC) for PCT at enrolment was used to characterize their utility for discriminating bacterial/mixed and viral pathogens and for determining the best cut-off values. For this analysis, a total of 155 subjects with confirmed bacterial/mixed or viral infections were included.

5 secondary outcomes

The Etiologies of Pneumonia in Children Expressed in Percentages of Enrolled Subjects.
Time frame: Total length of time the subject will be in the study is one month after enrollment.
The Clinical Outcome in Pneumonia Pediatric Subjects
Time frame: Total length of time the subject will be in the study is one month after enrollment.
The Percentage of Sign and Symptom of SoC Procedure
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Performance of Combined Factors in Differentiating Viral and Bacterial Infections
Time frame: Total length of time the subject will be in the study is one month after enrollment.
Number of Strains of Circulating Respiratory Viruses and Pathogens in Pediatric Pneumonia Subjects
Time frame: Total length of time the subject will be in the study is one month after enrollment.

Results and safety

Results posted to the registry on 4 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hospitalized Pediatric Participants With Pneumonia	188	188

Primary outcome: White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens

Time frame: Total length of time the subject will be in the study is one month after enrollment.. Number. Unit: 10^3 cells/microliter

Measure	White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens n = 155	Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens n = 155
Value	12.2	6.15

White Blood Cells Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens: AUC: 0.6692 (95% CI 0.5649 to 0.7735), p = 0.0048, ROC Curve Analysis
Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens: AUC: 0.6892 (95% CI 0.5870 to 0.7914), p = 0.0029, ROC Curve Analysis

Population analysed: All subjects with confirmed etiology.

Primary outcome: Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens

Time frame: Total length of time the subject will be in the study is one month after enrollment.. Number. Unit: ratio

Measure	Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens n = 155
Value	1.34

Neutrophil Lymphocyte Ratio Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens: AUC: 0.6440 (95% CI 0.5335 to 0.7544), p = 0.0233, ROC Curve Analysis

Population analysed: All subjects with confirmed etiology.

Primary outcome: CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens

Time frame: Total length of time the subject will be in the study is one month after enrollment.. Number. Unit: mg/dL

Measure	CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens (mg/L) n = 155
Value	5.70

CRP Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens (mg/L): AUC: 0.6884 (95% CI 0.5962 to 0.7807), p = 0.0018, ROC Curve Analysis

Population analysed: All subjects with confirmed etiology.

Primary outcome: Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens

Time frame: Total length of time the subject will be in the study is one month after enrollment.. Number. Unit: ng/mL

Measure	Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens (ng/mL) n = 155
Value	0.141

Procalcitonin Cut-off for Distinguishing of Viral and Bacterial/Mixed Pathogens (ng/mL): AUC: 0.7063 (95% CI 0.6111 to 0.8015), p = 0.0007, ROC Curve Analysis

Population analysed: All subjects with confirmed etiology.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years, 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Obervational	0 of 188 (0%)	1 of 188 (0.5%)	19 of 188

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35728910Lokida D, Farida H, Triasih R, Mardian Y, Kosasih H, Naysilla AM, Budiman A, Hayuningsih C, Anam MS, Wastoro D, Mujahidah M, Dipayana S, Setyati A, Aman AT, Lukman N, Karyana M, Kline A, Neal A, Lau CY, Lane C. Epidemiology of community-acquired pneumonia among hospitalised children in Indonesia: a multicentre, prospective study. BMJ Open. 2022 Jun 21;12(6):e057957. doi: 10.1136/bmjopen-2021-057957.
Individual participant dataSharing planned: No

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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.

Dr. Herman Kosasih, PhD principal investigator

Ina-Respond

4 sites 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 INA-RESPOND Secretariat at 4 sites in Indonesia.

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 10 inclusion and 4 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Indonesia. 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?

Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

White Blood Cells and Absolute Neutrophil Count Cut-off Levels for Distinguishing of Viral and Bacterial/Mixed Pathogens (time frame: Total length of time the subject will be in the study is one month after enrollment.). 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 NCT03366454, 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 4 Jun 2025.