NCT05114902

Brief Summary

Prospective, observational, hospital based, nasopharyngeal carriage (NPC), vaccine effectiveness study Comparisons will be made in Filipino children, aged 8 weeks to ≤60 months of age at enrollment, who have been hospitalized with a radiologically-confirmed, community-acquired pneumonia (CAP).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
451

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

November 24, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

October 29, 2021

Last Update Submit

September 11, 2023

Conditions

Community-acquired Pneumonia

Keywords

Clinical CAP

Outcome Measures

Primary Outcomes (4)

  • S. pneumoniae serotypes

    S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (PCMC)

    Upon Admission

  • S. pneumoniae serotypes Upon Admission

    S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (SPMC)

    Upon Admission

  • Antimicrobial resistance rate of S. pneumoniae

    Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13- unvaccinated site (PCMC)

    Upon Admission

  • Antimicrobial resistance rate of S. pneumoniae

    Antimicrobial resistance rate isolated from the nasopharynx of children admitted as a case of radiologic CAP admitted in PCV13-vaccinated site (SPMC)

    Upon Admission

Study Arms (2)

PCV13 Non-vaccinated Settting

Pneumococcal vaccine-naïve children at the PCMC

Diagnostic Test: Nasopharyngeal swab

PCV13 Vaccinated Setting

Pneumococcal vaccine-exposed children at the SPMC

Diagnostic Test: Nasopharyngeal swab

Interventions

Nasopharyngeal swabDIAGNOSTIC_TEST

A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage

PCV13 Non-vaccinated SetttingPCV13 Vaccinated Setting

Eligibility Criteria

Age8 Weeks - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children 8 weeks to ≤60 months of age from the National Capital Region (NCR) or Region X-XIII admitted with a medical diagnosis of clinical community-acquired pneumonia (CAP), confirmed by an abnormal chest x-ray. In Region X-XIII, the child must have received at least 1 dose of PCV13 given at \<12 months.

You may qualify if:

  • Child 8 weeks to ≤60 months of age
  • Resident of the National Capital Region (NCR) or Region X-XIII
  • Child admitted with a medical diagnosis of clinical CAP based on history and physical exam
  • Written informed consent obtained from a parent or legal guardian
  • At SPMC site, child must have received at least 1 dose of PCV13 given at \<12 months based on history-taking
  • For Phase B at PCMC site, child must have received at least 1 dose of PCV13 given at \<12 months based on history-taking

You may not qualify if:

  • Children with a known primary or secondary immunodeficiency
  • Child with a contraindication to doing a nasopharyngeal swab which may include, but is not limited to: dyscrasias, coagulation disorders, or other diseases (e.g., hemophilia, purpura), presence of craniofacial abnormalities32
  • For Phase A at PCMC site, child with any PCV in the past based on history-taking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philippine Children's Medical Center

Quezon City, National Capital Region, Philippines

Location

Biospecimen

Retention: SAMPLES WITH DNA

The retained specimen will consist of isolates of Streptococcus pneumoniae cultured from the nasopharyngeal swab.

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Marilla G Lucero, MD

    Asian Foundation for Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 10, 2021

Study Start

November 24, 2021

Primary Completion

July 31, 2023

Study Completion

November 1, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

PH(1)