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

Pneumonia Clinical Trial

Official title:

A Polymerase Chain Reaction-based Method to Improve Antibiotic Prescribing for Children and Adolescents With Community-Acquired Pneumonia - a Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00867841
• Other study ID #: CHEO-ID-001
• Status: Withdrawn
• Phase: N/A
• First received: March 23, 2009
• Last updated: February 24, 2016

Study information

• Verified date: February 2016
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 180 Days and older

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumonia

Intervention

Procedure:
• nasopharyngeal swab
PCR of NP swab for Mycoplasma, Chlamydophila, pneumococcus, pneumococcus macrolide resistance genes.

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (26)

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Rouphael NG, Atwell-Melnick N, Longo D, Whaley M, Carlone GM, Sampson JS, Ades EW. A real-time polymerase chain reaction for the detection of Streptococcus pneumoniae in blood using a mouse model: a potential new "gold standard". Diagn Microbiol Infect Dis. 2008 Sep;62(1):23-5. doi: 10.1016/j.diagmicrobio.2008.06.002. Epub 2008 Jul 14. — View Citation

Saukkoriipi A, Kaijalainen T, Kuisma L, Ojala A, Leinonen M. Isolation of pneumococcal DNA from nasopharyngeal samples for real-time, quantitative PCR: comparison of three methods. Mol Diagn. 2003;7(1):9-15. — View Citation

Shah SS, Alpern ER, Zwerling L, McGowan KL, Bell LM. Risk of bacteremia in young children with pneumonia treated as outpatients. Arch Pediatr Adolesc Med. 2003 Apr;157(4):389-92. — View Citation

Strålin K, Bäckman A, Holmberg H, Fredlund H, Olcén P. Design of a multiplex PCR for Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae and Chlamydophila pneumoniae to be used on sputum samples. APMIS. 2005 Feb;113(2):99-111. — View Citation

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* Note: There are 26 references in all — Click here to view all references