NCT01810861

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
922

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

April 6, 2023

Status Verified

December 1, 2020

Enrollment Period

6.6 years

First QC Date

March 12, 2013

Last Update Submit

April 4, 2023

Conditions

Keywords

serotype distributionstreptococcus pneumoniaepneumonia

Outcome Measures

Primary Outcomes (1)

  • Identification of S. pneumoniae serotype distribution

    4 years

Secondary Outcomes (1)

  • Identification of antibiotic susceptibility of the isolates

    4 years

Study Arms (1)

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

Interventions

This is a non-interventional study.

Serotype distribution (this is a non-interventional study)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Dokuz Eylul University Medical Faculty, Department of Chest Diseases

Balçova, İzmir, 35340, Turkey (Türkiye)

Location

Ankara Yüksek İhtisas Eğitim ve Araştırma Hastanesi Kardiyoloji Kliniği

Ankara / Altındağ, Turkey, 06230, Turkey (Türkiye)

Location

Gaziantep Universitesi Tip Fakultesi Mikrobiyoloji

Gaziantep, Turkiye, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi Mikrobiyoloji ve Klinik Mikrobiyoloji Anabilim Dali

Istanbul, Turkiye, Turkey (Türkiye)

Location

Cukurova Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali

Adana, 01330, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi Cocuk Enfeksiyon Hastaliklari Bilim Dali

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Meslek Hastalıkları Hastanesi

Ankara, Turkey (Türkiye)

Location

Sami Ulus Kadin Dogum Cocuk Sagligi ve Hastaliklari Egitim Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Location

Antalya Egitim ve Arastirma Hastanesi Tibbi Mikrobiyoloji

Antalya, 07100, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty Microbiology Department

Antalya, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty, Microbiology

Antalya, Turkey (Türkiye)

Location

Samsun Ondokuz Mayis Universitesi Tibbi Mikrobiyoloji ABD

Atakum Samsun, 55139, Turkey (Türkiye)

Location

Uludag Universitesi Tip Fakultesi Mikrobiyoloji ve Enfeksiyon Hastaliklari Anabilim Dali

Bursa, Turkey (Türkiye)

Location

Diyarbakir Dicle Universitesi Tibbi Mikrobiyoloji ABD

Diyarbakır, 21280, Turkey (Türkiye)

Location

Dicle Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali

Diyarbakır, Turkey (Türkiye)

Location

Firat Universitesi Tip Fakultesi Mikrobiyoloji ve Klinik Mikrobiyoloji Anabilim Dali

Elâzığ, Turkey (Türkiye)

Location

Osmangazi University Medical Faculty, Microbiology

Eskişehir, Turkey (Türkiye)

Location

Marmara Universitesi Tip Fakultesi

Istanbul, 34662, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa Tip Fakultesi Cocuk Sagligi ve Hastaliklari Ana Bilim Dali

Istanbul, Turkey (Türkiye)

Location

Ege University Medical Faculty, Microbiology

Izmir, Turkey (Türkiye)

Location

İzmir Tepecik Rearch and Training Hospital

Izmir, Turkey (Türkiye)

Location

Istanbul Okmeydani Egitim ve Arastirma Hastanesi Kagithane Semt Poliklinii

Kagithane Istanbul, 34000, Turkey (Türkiye)

Location

Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali

Kahramanmaraş, Turkey (Türkiye)

Location

Erciyes University Medical Faculty

Kayseri, Turkey (Türkiye)

Location

Kayseri Training and Research Hospital

Kayseri, Turkey (Türkiye)

Location

Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

Konak Izmir, 35210, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Faculty of Medicine Deparment of Pediatrics

Konya, Turkey (Türkiye)

Location

Mersin University Medical Faculty, Microbiology

Mersin, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty Hospital

Samanpazari, Ankara, 06100, Turkey (Türkiye)

Location

Selcuk Universitesi Tip Fakultesi Dahili Tip Bilimleri Bolumu Cocuk Sagligi ve Hastaliklari A.B.D

Selcuklu /konya, 42075, Turkey (Türkiye)

Location

Karadeniz Teknik Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali

Trabzon, Turkey (Türkiye)

Location

Van 100.Yl University Medical Faculty

Van, Turkey (Türkiye)

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, CSF and/or other sterile body areas (catheter, pleural fluid, parasynthesis fluid, pericardial fluid, synovial fluid, BAL)

MeSH Terms

Conditions

Pneumococcal InfectionsPneumonia

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

January 4, 2013

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

April 6, 2023

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

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.

Locations