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

NCT01810861

Last updated date
Study Location
Gaziantep Universitesi Tip Fakultesi Mikrobiyoloji
Gaziantep, Turkiye, , Turkey
Contact
1-800-718-1021

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.
Show details

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Pneumococcal DiseasesSerotype Distribution of Streptococcus Pneumoniae That Causes Invasive Diseases at Children and Adults in Turkey NCT01810861
  1. Gaziantep, Turkiye
  2. Istanbul, Turkiye
  3. Adana,
  4. Ankara,
  5. Ankara,
  6. Ankara,
  7. Ankara,
  8. Antalya,
  9. Antalya,
  10. Antalya,
  11. Atakum Samsun,
  12. Bursa,
  13. Diyarbakir,
  14. Diyarbakir,
  15. Elazig,
  16. Erzurum,
  17. Eskisehir,
  18. Istanbul,
  19. Istanbul,
  20. Izmir,
  21. İzmir,
  22. Kagithane Istanbul,
  23. Kahramanmaras,
  24. Kayseri,
  25. Kayseri,
  26. Konak Izmir,
  27. Konya,
  28. Mersin,
  29. Samanpazari, Ankara,
  30. Selcuklu /konya,
  31. Trabzon,
  32. Van,
  33. Balcova, Izmir
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Serotype Distribution of Streptococcus Pneumoniae That Causes Invasive Diseases at Children and Adults in Turkey
Official Title SEROTYPE DISTRIBUTION AND ANTIBIOTIC SUSCEPTIBILITY OF STREPTOCOCCUS PNEUMONIAE CAUSING INVASIVE DISEASES IN CHILDREN AND ADULTS: A LABORATORY- BASED MULTICENTER RETROSPECTIVE STUDY
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.
Detailed Description Non-interventional observational study Descriptive analysis will be conducted.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood, CSF and/or other sterile body areas (catheter, pleural fluid, parasynthesis fluid, pericardial fluid, synovial fluid, BAL)
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.

Condition Pneumococcal Diseases
Intervention Other: There is no intervention in this study
This is a non-interventional study.
Study Groups/Cohorts Serotype 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 Status Recruiting
Estimated Enrollment
 (submitted: August 16, 2016)
1
Original Estimated Enrollment
 (submitted: March 12, 2013)
500
Estimated Study Completion Date November 30, 2020
Estimated Primary Completion Date November 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
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
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 Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT01810861
Other Study ID Numbers B1851148
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not 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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2020