Serotype Distribution of Streptococcus Pneumoniae That Causes Invasive Diseases at Children and Adults in Turkey

April 4, 2023 updated by: Pfizer

SEROTYPE DISTRIBUTION AND ANTIBIOTIC SUSCEPTIBILITY OF STREPTOCOCCUS PNEUMONIAE CAUSING INVASIVE DISEASES IN CHILDREN AND ADULTS: A LABORATORY- BASED MULTICENTER RETROSPECTIVE STUDY

The aim of this study is to specify the serotype distribution of Streptococcus pneumoniae that causes invasive diseases at children and adults in Turkey.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-interventional observational study Descriptive analysis will be conducted.

Study Type

Observational

Enrollment (Actual)

922

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01330
        • Cukurova Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali
      • Ankara, Turkey, 06100
        • Hacettepe Universitesi Tip Fakultesi Cocuk Enfeksiyon Hastaliklari Bilim Dali
      • Ankara, Turkey
        • Ankara Meslek Hastalıkları Hastanesi
      • Ankara, Turkey
        • Sami Ulus Kadin Dogum Cocuk Sagligi ve Hastaliklari Egitim Arastirma Hastanesi
      • Ankara / Altındağ, Turkey, 06230
        • Ankara Yüksek İhtisas Eğitim ve Araştırma Hastanesi Kardiyoloji Kliniği
      • Antalya, Turkey, 07100
        • Antalya Egitim ve Arastirma Hastanesi Tibbi Mikrobiyoloji
      • Antalya, Turkey
        • Akdeniz University Medical Faculty Microbiology Department
      • Antalya, Turkey
        • Akdeniz University Medical Faculty, Microbiology
      • Atakum Samsun, Turkey, 55139
        • Samsun Ondokuz Mayis Universitesi Tibbi Mikrobiyoloji ABD
      • Bursa, Turkey
        • Uludag Universitesi Tip Fakultesi Mikrobiyoloji ve Enfeksiyon Hastaliklari Anabilim Dali
      • Diyarbakir, Turkey, 21280
        • Diyarbakir Dicle Universitesi Tibbi Mikrobiyoloji ABD
      • Diyarbakir, Turkey
        • Dicle Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali
      • Elazig, Turkey
        • Firat Universitesi Tip Fakultesi Mikrobiyoloji ve Klinik Mikrobiyoloji Anabilim Dali
      • Eskisehir, Turkey
        • Osmangazi University Medical Faculty, Microbiology
      • Istanbul, Turkey, 34662
        • Marmara Universitesi Tip Fakultesi
      • Istanbul, Turkey
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi Cocuk Sagligi ve Hastaliklari Ana Bilim Dali
      • Izmir, Turkey
        • Ege University Medical Faculty, Microbiology
      • Kagithane Istanbul, Turkey, 34000
        • Istanbul Okmeydani Egitim ve Arastirma Hastanesi Kagithane Semt Poliklinii
      • Kahramanmaras, Turkey
        • Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali
      • Kayseri, Turkey
        • Erciyes University Medical Faculty
      • Kayseri, Turkey
        • Kayseri Training and Research Hospital
      • Konak Izmir, Turkey, 35210
        • Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
      • Konya, Turkey
        • Necmettin Erbakan University Meram Faculty of Medicine Deparment of Pediatrics
      • Mersin, Turkey
        • Mersin University Medical Faculty, Microbiology
      • Samanpazari, Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty Hospital
      • Selcuklu /konya, Turkey, 42075
        • Selcuk Universitesi Tip Fakultesi Dahili Tip Bilimleri Bolumu Cocuk Sagligi ve Hastaliklari A.B.D
      • Trabzon, Turkey
        • Karadeniz Teknik Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali
      • Van, Turkey
        • Van 100.Yl University Medical Faculty
      • İzmir, Turkey
        • İzmir Tepecik Rearch and Training Hospital
    • Izmir
      • Balcova, Izmir, Turkey, 35340
        • Dokuz Eylul University Medical Faculty, Department of Chest Diseases
    • Turkiye
      • Gaziantep, Turkiye, Turkey
        • Gaziantep Universitesi Tip Fakultesi Mikrobiyoloji
      • Istanbul, Turkiye, Turkey
        • Istanbul Universitesi Istanbul Tip Fakultesi Mikrobiyoloji ve Klinik Mikrobiyoloji Anabilim Dali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pneumococcal isolates that are obtained from the blood, CSF and/or other sterile body areas (catheter, pleural fluid, parasynthesis fluid, pericardial fluid, synovial fluid, BAL) with the aim of routine laboratory diagnosis from the pediatric patients that are younger than 18 years old (≤18), who are accepted to the pediatric clinic with the diagnosis of meningitides, bacteremia - sepsis or pneumonia, will be included in the trial.

S.pneumoniae isolates that meet the inclusion criteria and that are obtained from the invasive clinical samples of the adult patients that are over 18 years old (>18) and applied to the hospital are included in the trial.

Description

Inclusion Criteria:

Serotype distribution and antibiotic sensitivity of pneumococcal isolates that causes invasive pneumococcal diseases which are obtained from the blood, CSF, and/or all other sterile body areas (catheter, pleural fluid, parasynthesis fluid, pericardial fluid, synovial fluid, BAL) of the adults of 18 years of age or older with children that are younger than 18 years old at these centers and laboratories will be defined.

Exclusion Criteria:

Isolation of any other microorganism than pneumococcus at the same sample.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Serotype distribution (this is a non-interventional study)
Serotype distribution both in pediatrics and adults (this is a non interventional study)
Other: There is no intervention in this study
This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of S. pneumoniae serotype distribution
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Identification of antibiotic susceptibility of the isolates
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2013

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1851148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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