Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03366454
Status:
COMPLETED
Last Update Posted:
2020-12-30
First Post:
2017-11-08
Brief Title:
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
Sponsor:
INA-RESPOND Secretariat
Organization:
Ina-Respond
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEER-PePPes
Brief 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
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 sputuminduced 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
Whole blood serum urine Nasal Pharyngeal Swab NPS sputuminduced 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1263-2368 | OTHER | WHO UTN Number | None |