Clinical trial NCT05114902: PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study
Official title: Assessing the Impact of PCV13 on Pneumococcal Nasopharyngeal Colonization in Children 8 Weeks to ≤60 Months of Age Hospitalized for Pneumonia in the Philippines
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Community-acquired Pneumonia
Keywords: Clinical CAP
Lead sponsor: Asian Foundation for Tropical Medicine Inc.
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Philippine Children's Medical Center, Philippines
name: Southern Philippines Medical Center
First posted: 2021-11-10
Enrollment: 451
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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).

Detailed description: This study will be the first of two phases (A and B). Phase A will compare a PCV13-vaccinated setting (SPMC) with an unvaccinated setting (PCMC)

Eligibility criteria: Inclusion Criteria:

1. Child 8 weeks to ≤60 months of age
2. Resident of the National Capital Region (NCR) or Region X-XIII
3. Child admitted with a medical diagnosis of clinical CAP based on history and physical exam
4. Written informed consent obtained from a parent or legal guardian
5. At SPMC site, child must have received at least 1 dose of PCV13 given at \<12 months based on history-taking
6. 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:

1. Children with a known primary or secondary immunodeficiency
2. 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
3. For Phase A at PCMC site, child with any PCV in the past based on history-taking

Primary outcomes:
measure: S. pneumoniae serotypes
timeFrame: Upon Admission
measure: S. pneumoniae serotypes Upon Admission
timeFrame: Upon Admission
measure: Antimicrobial resistance rate of S. pneumoniae
timeFrame: Upon Admission
measure: Antimicrobial resistance rate of S. pneumoniae
timeFrame: Upon Admission
Secondary outcomes:
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: Philippine Children's Medical Center
state: National Capital Region
Study officials:
affiliation: Asian Foundation for Tropical Medicine
name: Marilla G Lucero, MD
role: PRINCIPAL_INVESTIGATOR
References: