Pneumococcal DiseasesNCT01810861
Serotype Distribution of Streptococcus Pneumoniae That Causes Invasive Diseases at Children and Adults in Turkey
An observational study of Pneumococcal Diseases, run by Pfizer at 32 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumococcal Diseases
- How many people
- 922 participants
- Where
- 32 sitesTurkey (Türkiye)
- Study dates
- 4 Jan 2013to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Isolation of any other microorganism than pneumococcus at the same sample.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Turkey (Türkiye)32 sites
Cukurova Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali
Adana, 01330
Hacettepe Universitesi Tip Fakultesi Cocuk Enfeksiyon Hastaliklari Bilim Dali
Ankara, 06100
Ankara Meslek Hastalıkları Hastanesi
Ankara
Sami Ulus Kadin Dogum Cocuk Sagligi ve Hastaliklari Egitim Arastirma Hastanesi
Ankara
Ankara Yüksek İhtisas Eğitim ve Araştırma Hastanesi Kardiyoloji Kliniği
Ankara / Altındağ, Turkey, 06230
Antalya Egitim ve Arastirma Hastanesi Tibbi Mikrobiyoloji
Antalya, 07100
Akdeniz University Medical Faculty Microbiology Department
Antalya
Akdeniz University Medical Faculty, Microbiology
Antalya
Samsun Ondokuz Mayis Universitesi Tibbi Mikrobiyoloji ABD
Atakum Samsun, 55139
Dokuz Eylul University Medical Faculty, Department of Chest Diseases
Balçova, İzmir, 35340
Uludag Universitesi Tip Fakultesi Mikrobiyoloji ve Enfeksiyon Hastaliklari Anabilim Dali
Bursa
Diyarbakir Dicle Universitesi Tibbi Mikrobiyoloji ABD
Diyarbakır, 21280
Dicle Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali
Diyarbakır
Firat Universitesi Tip Fakultesi Mikrobiyoloji ve Klinik Mikrobiyoloji Anabilim Dali
Elâzığ
Osmangazi University Medical Faculty, Microbiology
Eskişehir
Gaziantep Universitesi Tip Fakultesi Mikrobiyoloji
Gaziantep, Turkiye
Istanbul Universitesi Istanbul Tip Fakultesi Mikrobiyoloji ve Klinik Mikrobiyoloji Anabilim Dali
Istanbul, Turkiye
Marmara Universitesi Tip Fakultesi
Istanbul, 34662
Istanbul Universitesi Cerrahpasa Tip Fakultesi Cocuk Sagligi ve Hastaliklari Ana Bilim Dali
Istanbul
Ege University Medical Faculty, Microbiology
Izmir
İzmir Tepecik Rearch and Training Hospital
Izmir
Istanbul Okmeydani Egitim ve Arastirma Hastanesi Kagithane Semt Poliklinii
Kagithane Istanbul, 34000
Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali
Kahramanmaraş
Erciyes University Medical Faculty
Kayseri
Kayseri Training and Research Hospital
Kayseri
Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Konak Izmir, 35210
Necmettin Erbakan University Meram Faculty of Medicine Deparment of Pediatrics
Konya
Mersin University Medical Faculty, Microbiology
Mersin
Hacettepe University Medical Faculty Hospital
Samanpazari, Ankara, 06100
Selcuk Universitesi Tip Fakultesi Dahili Tip Bilimleri Bolumu Cocuk Sagligi ve Hastaliklari A.B.D
Selcuklu /konya, 42075
Karadeniz Teknik Universitesi Tip Fakultesi Tibbi Mikrobiyoloji Anabilim Dali
Trabzon
Van 100.Yl University Medical Faculty
Van
About this study
Official title: SEROTYPE DISTRIBUTION AND ANTIBIOTIC SUSCEPTIBILITY OF STREPTOCOCCUS PNEUMONIAE CAUSING INVASIVE DISEASES IN CHILDREN AND ADULTS: A LABORATORY- BASED MULTICENTER RETROSPECTIVE STUDY
The aim of this study is to specify the serotype distribution of Streptococcus pneumoniae that causes invasive diseases at children and adults in Turkey.
Read the detailed description
Non-interventional observational study Descriptive analysis will be conducted.
- Conditions
- Pneumococcal Diseases
- Being tested
- There is no intervention in this study
- Keywords
- serotype distribution, streptococcus pneumoniae, pneumonia
- Medical subject headings
- Pneumococcal Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in this studyOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Serotype distribution (this is a non-interventional study) | Serotype distribution both in pediatrics and adults (this is a non interventional study) Receives: Other: There is no intervention in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of S. pneumoniae serotype distribution
Measured: 4 years
Secondary outcomes (1)
Identification of antibiotic susceptibility of the isolates
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study start4 Jan 2013
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseasesStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 922 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810861
- Sponsor's protocol ID
- B1851148
- Status last verified
- Dec 2020
- First submitted
- 12 Mar 2013
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEROTYPE DISTRIBUTION AND ANTIBIOTIC SUSCEPTIBILITY OF STREPTOCOCCUS PNEUMONIAE CAUSING INVASIVE DISEASES IN CHILDREN AND ADULTS: A LABORATORY- BASED MULTICENTER RETROSPECTIVE STUDY
- ClinicalTrials.gov ID
- NCT01810861
- Acronym / sponsor ID
- B1851148
- Conditions
- Pneumococcal Diseases
- Keywords
- serotype distribution, streptococcus pneumoniae, pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 922 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2013 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serotype distribution (this is a non-interventional study) | – | Other: There is no intervention in this studySerotype distribution both in pediatrics and adults (this is a non interventional study) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Isolation of any other microorganism than pneumococcus at the same sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention in this studyThis is a non-interventional study. | Other | Serotype distribution (this is a non-interventional study) |
Primary outcome
Identification of S. pneumoniae serotype distribution
Time frame: 4 years
1 secondary outcome
Identification of antibiotic susceptibility of the isolates
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Diseases, run by Pfizer at 32 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of S. pneumoniae serotype distribution (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.