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

This study has suspended participant recruitment.
(funding issues)
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT00867841
First received: March 23, 2009
Last updated: May 16, 2013
Last verified: June 2009
  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)


Estimated Enrollment: 100
Study Start Date: June 2009
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

Ages Eligible for Study:   180 Days and older
Genders Eligible for Study:   Both
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
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: 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
Study First Received: March 23, 2009
Last Updated: May 16, 2013
Health Authority: Canada: Health Canada

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
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 25, 2014