Pneumococcal Nasopharyngeal and Oropharyngeal Carriage in Adults

NCT04831788 | Completed Results

• 1 other identifier: 01-1093/2
• Study Type: observational
• Target: 521
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first baseline pilot-study that will evaluate the NP and OP colonization with the underline of pneumococcal serotype distribution among adults older than 50 years of age in Serbia and Southeastern Europe. Results of this project will serve as additional evidence in order to increase coverage among adults and elderly

Conditions

Preference, Patient

Outcome Measures

Primary Outcomes (1)

• Prevalence

  Prevalence will be measured as a number of participants with positive isolates divided with overall number of participants analyzed and multiplied by a hundred to determine a percentage of positives

  90 days

Secondary Outcomes (1)

• Number of Participants With Spn Serotypes

  150 days

Study Arms (1)

Adults

Adults older than 50 years of age, residing in the city of Novi Sad, Serbia and providing oropharyngeal and nasopharyngeal swab specimen upon signing informed consent

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target group of the research will be all adults who will visit their elected physicians in the Health Care Centre of Novi Sad (outpatient care facility). Only adults older than 50 years of age from Novi Sad with 341,624 (2011 Census) inhabitants will be recruited in this research. All patients older than 50 years of age will be interviewed by physicians at the admission. Nasopharyngeal and oropharyngeal swabs will be obtained and transported to the Institute of Public Health for the laboratory analyses.

You may qualify if:

• Adults older than 50 years of age visiting the Health Care Centre with or without signs of upper respiratory tract infection during the study period

You may not qualify if:

• Living outside of Novi Sad, use of oral antibiotics in the two weeks prior to taking the swab and presence of a confirmed immunodeficiency (hematological malignancies, inherited immunodeficiency, HIV, post-splenectomy status, cancer chemotherapy).

Sponsors & Collaborators

• University of Novi Sad: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Health Care Centre Novi Sad

Novi Sad, Vojvodina, 21101, Serbia

Location

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Prof. Vladimir Petrovic
• Organization: University of Novi Sad, Faculty of Medicine

vladimir.petrovic@izjzv.org.rs

+381648028800

Study Officials

• Biljana Bozin, Ph.D

  University of Novi Sad, Medical Facultz

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: June 2, 2021
• Primary Completion: October 26, 2021
• Study Completion: January 7, 2022
• Last Updated: November 1, 2023
• Results First Posted: November 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)