Trial record 6 of 887 for:
chest x ray
Serotype Distribution of Chest-x-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year. (B1851065)
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01564771
First received: March 26, 2012
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
Recent nation-wide resistance prevalence rates originate from a nation-wide surveillance study coordinated by the 4th Dept of Internal Medicine, Athens University General Hospital ATTIKON. Penicillin resistance rates from this study differ if the new IDSA breakpoints for non-meningeal strains are applied, lowering nonsusceptibility rates to penicillin from 34,7% and 48,3% to 3,9% and 8% for colonising and resistant strains respectively. Serotypes 19F, 14, 9V, 23F and 6B formed 70.6% of the total number of resistant strains serotyped. There is an unmet scientific need to find the serotype distribution in Greece in adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumococcal Disease |
Other: Non Intervention |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Serotype Distribution of Chest-x-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The frequency of serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, 19A in the samples collected from chest-X-ray confirmed pneumococcal pneumonia (CAP) adult patients [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients. [ Time Frame: One year ] [ Designated as safety issue: No ]
- The frequency of the 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, 19A serotypes (based on Luminex assay) of study patients immunized and not immunized with PPV. [ Time Frame: One year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Urine Samples
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group one
Adults over 18 years of age with positive Xray for CAP
|
Other: Non Intervention
This Is A Non Interventional Study
|
Detailed Description:
For each surveillance period lasting for 12 months all adults presenting in the selected clinics with symptoms and signs suggestive of pneumonia (candidate cases) will be asked to participate in the study
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adults over 18 years of age with positive Xray for CAP
Criteria
Inclusion Criteria:
- Subjects are ≥ 18 years of age (adults)
- Posteroanterior or anteroposterior chest-X-ray showing an infiltrate (if previous films are not available) or a new infiltrate (of recent film is available)
- Subjects tested positive for Binax NOW® assay
Exclusion Criteria:
- Any subject who develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more
- Any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at another healthcare facility
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564771
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Greece | |
| General Hospital of Athens "Evangelismos" / Pneumonology Department | Recruiting |
| Athens, Attiki, Greece | |
| University Hospital of Alexandroupolis | Recruiting |
| Alexandroupoli, Evros, Greece, 68100 | |
| General University Hospital of Alexandroupoli | Recruiting |
| Alexandroupoli, Greece, 68100 | |
| General Hospital of Athens "Sotiria"/ 12Th Pneumonology Clinic | Recruiting |
| Athens, Greece, 11527 | |
| Diagnostic Therapeutic Center of Athens Ygeia | Recruiting |
| Athens, Greece, 15123 | |
| General Hospital Mellision "Amalia Fleming"/ Pneumonology Clinic | Recruiting |
| Athens, Greece, 15127 | |
| General Hospital of Athens "Sismanoglio"/ 2Nd Pneumonology Clinic | Recruiting |
| Athens, Greece, 15126 | |
| General Hospital of Athens "Sotiria"/ 5Th Pneumonology Clinic | Recruiting |
| Athens, Greece, 11527 | |
| General Hospital of Athens "Sotiria"/ 4Th Pneumonology Clinic | Recruiting |
| Athens, Greece, 11527 | |
| General Hospital of Athens "Sismanoglio" / 3Rd Pneumonology Department | Recruiting |
| Athens, Greece, 15126 | |
| General Hospital of Athens "Sotiria"/ 2Nd Pneumonology Clinic | Recruiting |
| Athens, Greece, 11527 | |
| General Hospital of Athens "Sotiria"/ 9Th Pneumonology Clinic | Not yet recruiting |
| Athens, Greece, 11527 | |
| Sotiria Hospital, Intensive Care Unit | Recruiting |
| Athens, Greece, 15227 | |
| General Hospital of Athens "Sotiria"/ 1St Pneumonology Clinic | Recruiting |
| Athens, Greece, 11527 | |
| General Hospital Mellision "Amalia Fleming"/2nd Internal Medicine Department | Recruiting |
| Athens, Greece, 15127 | |
| General Hospital of Athens "Sotiria"/ 8Th Pneumonology Clinic | Recruiting |
| Athens, Greece, 11527 | |
| General Hospital Athens "Sismanoglio"/ 1St Pneumonology Clinic | Recruiting |
| Athens, Greece, 15126 | |
| General Chest Diseases Hospital "Sotiria"/ 7th Department of Pulmonary Medicine | Recruiting |
| Athens, Greece, 11527 | |
| General Hospital of Athens "Sotiria"/ 6Th Pneumonology Clinic | Recruiting |
| Athens, Greece, 11527 | |
| General University Hospital "Attikgeneral University Hospital "Attikon"/ 4Th University Internal Med | Recruiting |
| Athnens, Greece | |
| General Hospital of Kavala/ A Pneumonological Clinic | Recruiting |
| Kavala, Greece, 65201 | |
| General Hospital of Kavala/ b Pneumonological & Tubeculosis Department | Recruiting |
| Kavala, Greece | |
| University General Hospial of Larissa, Pneumonology Department | Recruiting |
| Larissa, Greece, 41 110 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01564771 History of Changes |
| Other Study ID Numbers: | B1851065 |
| Study First Received: | March 26, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Pfizer:
|
Pneumococcal serotypes CAP |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 16, 2013