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

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ClinicalTrials.gov Identifier: NCT01810861
Recruitment Status : Recruiting
First Posted : March 14, 2013
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Pneumococcal Diseases Other: There is no intervention in this study

Detailed Description:
Non-interventional observational study Descriptive analysis will be conducted.

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: SEROTYPE DISTRIBUTION AND ANTIBIOTIC SUSCEPTIBILITY OF STREPTOCOCCUS PNEUMONIAE CAUSING INVASIVE DISEASES IN CHILDREN AND ADULTS: A LABORATORY- BASED MULTICENTER RETROSPECTIVE STUDY
Actual Study Start Date : January 4, 2013
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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.




Primary Outcome Measures :
  1. Identification of S. pneumoniae serotype distribution [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Identification of antibiotic susceptibility of the isolates [ Time Frame: 4 years ]

Biospecimen Retention:   Samples Without DNA
Blood, CSF and/or other sterile body areas (catheter, pleural fluid, parasynthesis fluid, pericardial fluid, synovial fluid, BAL)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810861


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com

Locations
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Turkey
Dokuz Eylul University Medical Faculty, Department of Chest Diseases Recruiting
Balcova, Izmir, Turkey, 35340
Gaziantep Universitesi Tip Fakultesi Mikrobiyoloji Recruiting
Gaziantep, Turkiye, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Mikrobiyoloji ve Klinik Mikrobiyoloji Anabilim Dali Recruiting
Istanbul, Turkiye, Turkey
Cukurova Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali Recruiting
Adana, Turkey, 01330
Hacettepe Universitesi Tip Fakultesi Cocuk Enfeksiyon Hastaliklari Bilim Dali Recruiting
Ankara, Turkey, 06100
Ankara Meslek Hastalıkları Hastanesi Recruiting
Ankara, Turkey
Sami Ulus Kadin Dogum Cocuk Sagligi ve Hastaliklari Egitim Arastirma Hastanesi Active, not recruiting
Ankara, Turkey
Sami Ulus Kadin Dogum Cocuk Sagligi ve Hastaliklari Egitim Arastirma Hastanesi Recruiting
Ankara, Turkey
Antalya Egitim ve Arastirma Hastanesi Tibbi Mikrobiyoloji Recruiting
Antalya, Turkey, 07100
Akdeniz University Medical Faculty Microbiology Department Recruiting
Antalya, Turkey
Akdeniz University Medical Faculty, Microbiology Active, not recruiting
Antalya, Turkey
Samsun Ondokuz Mayis Universitesi Tibbi Mikrobiyoloji ABD Active, not recruiting
Atakum Samsun, Turkey, 55139
Uludag Universitesi Tip Fakultesi Mikrobiyoloji ve Enfeksiyon Hastaliklari Anabilim Dali Recruiting
Bursa, Turkey
Diyarbakir Dicle Universitesi Tibbi Mikrobiyoloji ABD Recruiting
Diyarbakir, Turkey, 21280
Dicle Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali Active, not recruiting
Diyarbakir, Turkey
Firat Universitesi Tip Fakultesi Mikrobiyoloji ve Klinik Mikrobiyoloji Anabilim Dali Active, not recruiting
Elazig, Turkey
Ataturk University Medical Faculty Not yet recruiting
Erzurum, Turkey
Osmangazi University Medical Faculty, Microbiology Recruiting
Eskisehir, Turkey
Marmara Universitesi Tip Fakultesi Recruiting
Istanbul, Turkey, 34662
Istanbul Universitesi Cerrahpasa Tip Fakultesi Cocuk Sagligi ve Hastaliklari Ana Bilim Dali Recruiting
Istanbul, Turkey
Ege University Medical Faculty, Microbiology Recruiting
Izmir, Turkey
İzmir Tepecik Rearch and Training Hospital Recruiting
İzmir, Turkey
Istanbul Okmeydani Egitim ve Arastirma Hastanesi Kagithane Semt Poliklinii Recruiting
Kagithane Istanbul, Turkey, 34000
Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali Active, not recruiting
Kahramanmaras, Turkey
Erciyes University Medical Faculty Active, not recruiting
Kayseri, Turkey
Kayseri Training and Research Hospital Recruiting
Kayseri, Turkey
Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi Recruiting
Konak Izmir, Turkey, 35210
Necmettin Erbakan University Meram Faculty of Medicine Deparment of Pediatrics Active, not recruiting
Konya, Turkey
Mersin University Medical Faculty, Microbiology Recruiting
Mersin, Turkey
Hacettepe University Medical Faculty Hospital Recruiting
Samanpazari, Ankara, Turkey, 06100
Selcuk Universitesi Tip Fakultesi Dahili Tip Bilimleri Bolumu Cocuk Sagligi ve Hastaliklari A.B.D Recruiting
Selcuklu /konya, Turkey, 42075
Karadeniz Teknik Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali Recruiting
Trabzon, Turkey
Van 100.Yl University Medical Faculty Recruiting
Van, Turkey
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01810861     History of Changes
Other Study ID Numbers: B1851148
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
serotype distribution
streptococcus pneumoniae
pneumonia
Additional relevant MeSH terms:
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Pneumococcal Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections