UnknownNot Applicable

PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study

Philippines451 participantsStarted 2021-11-24

Plain-language 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).

Who can participate

Age range8 Weeks – 60 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

S. pneumoniae serotypes

Timeframe: Upon Admission

S. pneumoniae serotypes Upon Admission

Timeframe: Upon Admission

Antimicrobial resistance rate of S. pneumoniae

Timeframe: Upon Admission

Antimicrobial resistance rate of S. pneumoniae

Timeframe: Upon Admission

Trial details

NCT IDNCT05114902

SponsorAsian Foundation for Tropical Medicine Inc.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-31

View on ClinicalTrials.gov More Community-acquired Pneumonia trials

Who can participate

Age range8 Weeks – 60 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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