Serotype Distribution of Chest-x-ray Confirmed Pneumococcal Community Acquired Pneumonia in the Adult Population in Greece, Over 1 Year. (B1851065)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01564771
First received: March 26, 2012
Last updated: September 23, 2013
Last verified: September 2013
  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


Enrollment: 320
Study Start Date: January 2011
Study Completion Date: April 2013
Primary Completion Date: April 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564771

Locations
Greece
General Hospital of Athens "Evangelismos" / Pneumonology Department
Athens, Attiki, Greece
University Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece, 68100
General University Hospital of Alexandroupoli
Alexandroupoli, Greece, 68100
General Hospital Athens "Sismanoglio"/ 1St Pneumonology Clinic
Athens, Greece, 15126
General Hospital Mellision "Amalia Fleming"/ Pneumonology Clinic
Athens, Greece, 15127
General Hospital Mellision "Amalia Fleming"/2nd Internal Medicine Department
Athens, Greece, 15127
General Hospital of Athens "Sotiria"/ 6Th Pneumonology Clinic
Athens, Greece, 11527
General Hospital of Athens "Sismanoglio"/ 2Nd Pneumonology Clinic
Athens, Greece, 15126
General Hospital of Athens "Sotiria"/ 12Th Pneumonology Clinic
Athens, Greece, 11527
General Hospital of Athens "Sotiria"/ 8Th Pneumonology Clinic
Athens, Greece, 11527
General Hospital of Athens "Sotiria"/ 1St Pneumonology Clinic
Athens, Greece, 11527
General Hospital of Athens "Sotiria"/ 2Nd Pneumonology Clinic
Athens, Greece, 11527
General Chest Diseases Hospital "Sotiria"/ 7th Department of Pulmonary Medicine
Athens, Greece, 11527
Diagnostic Therapeutic Center of Athens Ygeia
Athens, Greece, 15123
General Hospital of Athens "Sismanoglio" / 3Rd Pneumonology Department
Athens, Greece, 15126
Sotiria Hospital, Intensive Care Unit
Athens, Greece, 15227
General Hospital of Athens "Sotiria"/ 5Th Pneumonology Clinic
Athens, Greece, 11527
General University Hospital "Attikgeneral University Hospital "Attikon"/ 4Th University Internal Med
Athnens, Greece
General Hospital of Kavala/ A Pneumonological Clinic
Kavala, Greece, 65201
General Hospital of Kavala/ b Pneumonological & Tubeculosis Department
Kavala, Greece, 65201
University General Hospial of Larissa, Pneumonology Department
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: September 23, 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 July 22, 2014