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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01810861
Other study ID # B1851148
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2013
Est. completion date July 31, 2019

Study information

Verified date December 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Non-interventional observational study Descriptive analysis will be conducted.


Recruitment information / eligibility

Status Completed
Enrollment 922
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
There is no intervention in this study
This is a non-interventional study.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of S. pneumoniae serotype distribution 4 years
Secondary Identification of antibiotic susceptibility of the isolates 4 years
See also
  Status Clinical Trial Phase
Completed NCT02126384 - Identifocation the B Cell Subsets Responsible for Anti-pneumococcal Response N/A