Implementing a Combination of Clinical Parameters, Biomarkers and SoCs for the Etiology Diagnoses of Pneumonia in Pediatric Patients (PEER-PePPes)

INA-RESPOND Secretariat

Status: Completed

Conditions: Pneumonia

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03366454

INA201

U1111-1263-2368 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: No Healthy Volunteers

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)

Trial design