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

Pneumonia Clinical Trial

— PEER-PePPes  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366454
• Other study ID #: INA201
• Secondary ID: U1111-1263-2368
• Status: Completed
• Start date: July 4, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2020
• Source: Ina-Respond
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The participations will be ended by day 30th after hospitalization date when the called follow up is done by investigator.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 5 Years

Eligibility

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Pneumonia

Locations

Country	Name	City	State
Indonesia	University of Diponegoro/ Dr. Kariadi Hospital	Semarang	Central Java
Indonesia	An-Nisa Hospital	Tangerang	West Java
Indonesia	RSU Kabupaten Tangerang	Tangerang	West Java
Indonesia	University of Gadjah Mada/ Dr. Sardjito Hospital	Yogyakarta	DIY Yogyakarta

Sponsors (3)

Lead Sponsor	Collaborator
INA-RESPOND Secretariat	Indonesia Research Partnership on Infectious Disease (INA-RESPOND), United States Agency for International Development (USAID)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop an algorithm for the diagnosis of viral and bacterial pathogens in pediatric patients with pneumonia.	Develop the algorithm for the diagnosis of viral and bacterial pathogens from 275 enrolled paediatric patients with pneumonia by identified pathogens from each clinical diagnosis	26 Months
Secondary	To identify the etiologies of pneumonia in children in Indonesia, which are currently unavailable.	The etiology (bacteria, viruses, parasites, fungi and others) of pneumonia in children expressed in percentages of enrolled subjects.	26 Months
Secondary	To document outcomes in pediatric patients with pneumonia in Indonesia.	Report the outcomes of paediatric patients with pneumonia in Indonesia expressed in percentages of enrolled subjects and the proportions of subjects within each category defined by cured, improved, worsened and death.	26 Months
Secondary	To evaluate the performance of each rapid point of care test and standard of care procedures (Chest X-ray) compared to the gold standard molecular assays in differentiating virus and bacterial infections.	Measuring sensitivity and specificity of selected RTDs, biomarkers of bacterial infections, standard of care procedures against result in the gold standard along with 97.5% confidence intervals.	26 Months
Secondary	To analyze the performance of combined tests in differentiating virus and bacterial infections. Sensitivities and specificities of combined tests in differentiating virus and bacterial infections in pneumonia.	Measuring sensitivity and specificity of combined tests (RTDs and biomarker of bacterial infections versus standard of care procedures; standard of care procedures versus the gold standard) in differentiating virus and bacterial infections along with 97.5% confidence intervals.	26 Months
Secondary	To provide information regarding updated strains of circulating respiratory viruses and pathogens in children.	Report the strains of circulating respiratory viruses and pathogens of pediatric patients with pneumonia in Indonesia expressed in percentages of the identified strains from the enrolled subjects.	[Time Frame: 26 Months]