Pneumococcal Nasopharyngeal Carriage in Thai Childre

Phase 2

• Conditions: Healthy Thai children aged 1 month to not more than 5 years; nasopharyngeal carriage; seroprevalence; pneumococcal conjugate vaccine; streptococcus pneumonia; antimicrobial susceptibility

• Registration Number: TCTR20240624005
• Lead Sponsor: Pediatric Infectious Disease Society of Thailand (PIDST)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-24
• Last Update Posted: 19 August 2024
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1.Male or female participants aged 1 month to not more than 5 years.
2.Participants who are in good health at the time of entry to the trial, as determined by medical history and the clinical judgment of the investigator.
3.Parents/guardians/legal representatives of the participants must provide consent and sign the informed consent form prior to the initiation of any trial procedures.

Exclusion Criteria

1.Having a body temperature of 38 degrees Celsius (100.4 degrees Fahrenheit) or higher within 24 hours prior to enrollment in the trial.
2.Having respiratory symptoms on the day of entry to the trial.
3.Having a chronic disease that is unstable and whose symptoms cannot be controlled.
4.Having an immune deficiency or receiving immunosuppressive drugs or steroids.
5.Receiving antibiotics within 72 hours prior to enrollment in the trial.
6.Having any abnormalities or medical history that the investigator deems unsuitable for participation in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pneumococcal carriage prevalence and serotype NA real-time PCR and conventional PCR

Secondary Outcome Measures

Name	Time	Method
Antimicrobial resistance pattern of pneumococcal colonization NA Clinical and Laboratory Standards Institute (CLSI) guidelines