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Completed

NCT Number: NCT01564771

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

Serotype distribution and estimation of antimicrobial resistance in S. pneumoniae isolates and anticipated PCV7 and PCV13 coverage is difficult in Greece, because invasive isolates collected each year are limited and depict a certain proportion of patients who have easy access to tertiary care or have underlying medical reasons which necessitate inpatient care. It is also probable that the real burden of pneumococcal disease is not well estimated especially among adults. New additions in the laboratory setting such as the pneumococcal urine antigen assay (Binax NOW®) and the Urinary Antigen Diagnostic Assay (Luminex) for the detection of 13 serotype specific polysaccharides in human urine developed by Pfizer might be helpful in identifying more pneumococcal infections compared to the previous years. This NIS is based on the unmet scientific need to describe the serotype distribution and the resistance profile of isolates from X-Ray confirmed CAP in the present circumstances.

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Community-Acquired Infections Community-Acquired Pneumonia Gram-Positive Bacterial Infections Infections Pneumococcal Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Athens "Evangelismos" / Pneumonology Department, Athens, Attica, Greece

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who agreed to participate in the study and agreed to sign an ICD.
  • Patients had to be ≥18 years of age (adults)
  • Patients had to present or had been referred to a participating healthcare facility with suspected pneumonia based on the physician's assessment (including but not limited to specific signs and symptoms described in Section 9.3 of the protocol)
  • Patients must have had a posteroanterior or anteroposterior chest X-ray showing an infiltrate (if previous films were not available) or a new infiltrate (if recent film was available)
  • Patients had to be tested positive for the Binax NOW® assay (required post Protocol Amendment 2)

Exclusion criteria

  • Patients who did not sign an ICD.
  • Any patient who developed signs and symptoms of pneumonia after being hospitalized for ≥48 hours
  • Any patient who was transferred to a study healthcare facility after already being hospitalized for ≥48 hours at another healthcare facility
  • Patients who did not have a chest X-ray performed
  • Patients who did not have the Binax NOW® assay performed
  • Patients with negative results for the Binax NOW® assay (required post Protocol Amendment 2)

Treatment and study plan

Non intervention

Other

This Is A Non Interventional Study

Primary outcomes

  1. The frequency of serotypes 4,6B,9V,14,18C,19F,23F,1,3,5,6A,7F and 19A from chest X-ray confirmed pCAP patients (post amendment2 with positive Binax NOW® only) who presented in the emergency departments of 15 hospitals in Greece during 1

    Time frame: One year

  2. calendar year.

    Time frame: One year

Secondary outcomes

  1. Susceptibility, resistance or partial resistance Streptococcus pneumoniae clinical isolates obtained from study adult CAP patients.

    Time frame: One year

  2. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Acronym: B1851065

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2012
Registry last updated
Dec 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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