PCV13 Impact on Pneumococcal Nasopharyngeal Carriage Study

Community-acquired Pneumonia Clinical Trial

— IMPACT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05114902
• Other study ID #: CT-44 Study Protocol AFTM-01
• Status: Active, not recruiting
• Start date: November 24, 2021
• Est. completion date: November 2024

Study information

• Verified date: September 2023
• Source: Asian Foundation for Tropical Medicine Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 451
• Est. completion date: November 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Weeks to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Diagnostic Test:
• Nasopharyngeal swab
A sample obtained from the nasopharynx for detection of live pneumococci and pneumococcal respiratory carriage

Locations

Country	Name	City	State
Philippines	Philippine Children's Medical Center	Quezon City	National Capital Region

Sponsors (4)

Lead Sponsor	Collaborator
Asian Foundation for Tropical Medicine Inc.	Pfizer, Philippine Children's Medical Center, Philippines, Southern Philippines Medical Center

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S. pneumoniae serotypes	S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (PCMC)	Upon Admission
Primary	S. pneumoniae serotypes Upon Admission	S. pneumonia serotypes isolated from the nasopharynx of children admitted in PCV13-unvaccinated site (SPMC)	Upon Admission
Primary	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
Primary	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