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A Polymerase Chain Reaction (PCR) - Based Method to Improve Antibiotic Prescribing for Pneumonia

This study has been withdrawn prior to enrollment.
(funding issues and procedural problems)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00867841
First Posted: March 24, 2009
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Children's Hospital of Eastern Ontario
  Purpose
Pneumonia, or lung infection, is usually treated with antibiotics targeted against the organisms that the physician guesses are causing the problem. The determination of the exact cause of a patient's pneumonia is difficult. The problem is that the two major causes of community-acquired pneumonia are not easily distinguished on clinical grounds and are best treated by different antibiotics. The investigators hypothesize that antibiotic therapy can be targeted and improved by doing polymerase chain reaction (PCR) testing of nose swabs to identify probable implicated organisms and their antibiotic resistance patterns. This pilot study will be important to ensure that the laboratory testing is functional and that the emergency department-laboratory communication is optimal prior to doing a full-fledged randomized clinical trial.

Condition Intervention
Pneumonia Procedure: nasopharyngeal swab

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Polymerase Chain Reaction-based Method to Improve Antibiotic Prescribing for Children and Adolescents With Community-Acquired Pneumonia - a Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Biospecimen Retention:   Samples With DNA
nasopharyngeal swabs blood samples (for pneumococcal PCR)

Enrollment: 0
Groups/Cohorts Assigned Interventions
Pneumonia
Children diagnosed with community-acquired pneumonia by the emergency department physician
Procedure: nasopharyngeal swab
PCR of NP swab for Mycoplasma, Chlamydophila, pneumococcus, pneumococcus macrolide resistance genes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   180 Days and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children with community-acquired pneumonia presenting to the Children's Hospital of Eastern Ontario emergency department
Criteria

Inclusion Criteria:

  • presumed community-acquired pneumonia as diagnosed by the attending emergency department physician

Exclusion Criteria:

  • age > 6 months
  • immunodeficiency (primary, advanced HIV)
  • cystic fibrosis
  • malignancy
  • known cardiac or lung defects
  • bronchiectasis
  • previous pneumonia or lung abscess in past 6 months
  • conditions requiring treatment with immune suppressants
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867841


Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Jeffrey Pernica, MD Children's Hospital of Eastern Ontario/University of Ottawa
Study Director: Robert Slinger, MD Children's Hospital of Eastern Ontario/University of Ottawa
  More Information

Publications:

Responsible Party: Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00867841     History of Changes
Other Study ID Numbers: CHEO-ID-001
First Submitted: March 23, 2009
First Posted: March 24, 2009
Last Update Posted: February 25, 2016
Last Verified: February 2016

Keywords provided by Children's Hospital of Eastern Ontario:
pneumonia, community-acquired
polymerase chain reaction
pneumococcus
mycoplasma
chlamydophila
anti-bacterial agents

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents