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

Last updated on November 7, 2019

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Study Location
Gaziantep Universitesi Tip Fakultesi Mikrobiyoloji
Gaziantep, Turkiye, Turkey
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01810861
Pfizer
Recruiting
Serotype Distribution of Streptococcus Pneumoniae That Causes Invasive Diseases at Children and Adults in Turkey

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Descriptive Information
Brief TitleSerotype Distribution of Streptococcus Pneumoniae That Causes Invasive Diseases at Children and Adults in Turkey
Official TitleSEROTYPE DISTRIBUTION AND ANTIBIOTIC SUSCEPTIBILITY OF STREPTOCOCCUS PNEUMONIAE CAUSING INVASIVE DISEASES IN CHILDREN AND ADULTS: A LABORATORY- BASED MULTICENTER RETROSPECTIVE STUDY
Brief SummaryThe aim of this study is to specify the serotype distribution of Streptococcus pneumoniae that causes invasive diseases at children and adults in Turkey.
Detailed DescriptionNon-interventional observational study Descriptive analysis will be conducted.
Study TypeObservational
Study DesignObservational Model: Other
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
Blood, CSF and/or other sterile body areas (catheter, pleural fluid, parasynthesis fluid, pericardial fluid, synovial fluid, BAL)
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.

ConditionPneumococcal Diseases
InterventionOther: There is no intervention in this study
This is a non-interventional study.
Study Groups/CohortsSerotype distribution (this is a non-interventional study)
Serotype distribution both in pediatrics and adults (this is a non interventional study)
Intervention: Other: There is no intervention in this study
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: August 16, 2016)
1
Original Estimated Enrollment
 (submitted: March 12, 2013)
500
Estimated Study Completion DateNovember 30, 2020
Estimated Primary Completion DateNovember 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Contact: Pfizer Oncology Clinical Trial Information Service1-877-369-9753[email protected]
Listed Location CountriesTurkey
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01810861
Other Study ID NumbersB1851148
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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