- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00867841
A Polymerase Chain Reaction (PCR) - Based Method to Improve Antibiotic Prescribing for Pneumonia
February 24, 2016 updated by: Children's Hospital of Eastern Ontario
A Polymerase Chain Reaction-based Method to Improve Antibiotic Prescribing for Children and Adolescents With Community-Acquired Pneumonia - a Pilot Study
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.
Study Overview
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children with community-acquired pneumonia presenting to the Children's Hospital of Eastern Ontario emergency department
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pneumonia
Children diagnosed with community-acquired pneumonia by the emergency department physician
|
PCR of NP swab for Mycoplasma, Chlamydophila, pneumococcus, pneumococcus macrolide resistance genes.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Esposito S, Bosis S, Cavagna R, Faelli N, Begliatti E, Marchisio P, Blasi F, Bianchi C, Principi N. Characteristics of Streptococcus pneumoniae and atypical bacterial infections in children 2-5 years of age with community-acquired pneumonia. Clin Infect Dis. 2002 Dec 1;35(11):1345-52. doi: 10.1086/344191. Epub 2002 Nov 13.
- Michelow IC, Olsen K, Lozano J, Rollins NK, Duffy LB, Ziegler T, Kauppila J, Leinonen M, McCracken GH Jr. Epidemiology and clinical characteristics of community-acquired pneumonia in hospitalized children. Pediatrics. 2004 Apr;113(4):701-7. doi: 10.1542/peds.113.4.701.
- Tsolia MN, Psarras S, Bossios A, Audi H, Paldanius M, Gourgiotis D, Kallergi K, Kafetzis DA, Constantopoulos A, Papadopoulos NG. Etiology of community-acquired pneumonia in hospitalized school-age children: evidence for high prevalence of viral infections. Clin Infect Dis. 2004 Sep 1;39(5):681-6. doi: 10.1086/422996. Epub 2004 Aug 13.
- Juven T, Mertsola J, Waris M, Leinonen M, Meurman O, Roivainen M, Eskola J, Saikku P, Ruuskanen O. Etiology of community-acquired pneumonia in 254 hospitalized children. Pediatr Infect Dis J. 2000 Apr;19(4):293-8. doi: 10.1097/00006454-200004000-00006.
- Munoz-Almagro C, Jordan I, Gene A, Latorre C, Garcia-Garcia JJ, Pallares R. Emergence of invasive pneumococcal disease caused by nonvaccine serotypes in the era of 7-valent conjugate vaccine. Clin Infect Dis. 2008 Jan 15;46(2):174-82. doi: 10.1086/524660.
- Hicks LA, Harrison LH, Flannery B, Hadler JL, Schaffner W, Craig AS, Jackson D, Thomas A, Beall B, Lynfield R, Reingold A, Farley MM, Whitney CG. Incidence of pneumococcal disease due to non-pneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998-2004. J Infect Dis. 2007 Nov 1;196(9):1346-54. doi: 10.1086/521626. Epub 2007 Oct 4.
- Korppi M, Heiskanen-Kosma T, Kleemola M. Incidence of community-acquired pneumonia in children caused by Mycoplasma pneumoniae: serological results of a prospective, population-based study in primary health care. Respirology. 2004 Mar;9(1):109-14. doi: 10.1111/j.1440-1843.2003.00522.x.
- Chiang WC, Teoh OH, Chong CY, Goh A, Tang JP, Chay OM. Epidemiology, clinical characteristics and antimicrobial resistance patterns of community-acquired pneumonia in 1702 hospitalized children in Singapore. Respirology. 2007 Mar;12(2):254-61. doi: 10.1111/j.1440-1843.2006.01036.x.
- Byington CL, Spencer LY, Johnson TA, Pavia AT, Allen D, Mason EO, Kaplan S, Carroll KC, Daly JA, Christenson JC, Samore MH. An epidemiological investigation of a sustained high rate of pediatric parapneumonic empyema: risk factors and microbiological associations. Clin Infect Dis. 2002 Feb 15;34(4):434-40. doi: 10.1086/338460. Epub 2002 Jan 3.
- Eastham KM, Freeman R, Kearns AM, Eltringham G, Clark J, Leeming J, Spencer DA. Clinical features, aetiology and outcome of empyema in children in the north east of England. Thorax. 2004 Jun;59(6):522-5. doi: 10.1136/thx.2003.016105.
- Thomson AH, Hull J, Kumar MR, Wallis C, Balfour Lynn IM. Randomised trial of intrapleural urokinase in the treatment of childhood empyema. Thorax. 2002 Apr;57(4):343-7. doi: 10.1136/thorax.57.4.343.
- 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. doi: 10.1001/archpedi.157.4.389.
- Johansson N, Kalin M, Giske CG, Hedlund J. Quantitative detection of Streptococcus pneumoniae from sputum samples with real-time quantitative polymerase chain reaction for etiologic diagnosis of community-acquired pneumonia. Diagn Microbiol Infect Dis. 2008 Mar;60(3):255-61. doi: 10.1016/j.diagmicrobio.2007.10.011. Epub 2007 Nov 26.
- Lahti E, Mertsola J, Kontiokari T, Eerola E, Ruuskanen O, Jalava J. Pneumolysin polymerase chain reaction for diagnosis of pneumococcal pneumonia and empyema in children. Eur J Clin Microbiol Infect Dis. 2006 Dec;25(12):783-9. doi: 10.1007/s10096-006-0225-9.
- Le Monnier A, Carbonnelle E, Zahar JR, Le Bourgeois M, Abachin E, Quesne G, Varon E, Descamps P, De Blic J, Scheinmann P, Berche P, Ferroni A. Microbiological diagnosis of empyema in children: comparative evaluations by culture, polymerase chain reaction, and pneumococcal antigen detection in pleural fluids. Clin Infect Dis. 2006 Apr 15;42(8):1135-40. doi: 10.1086/502680. Epub 2006 Mar 7.
- Stralin K, Backman A, Holmberg H, Fredlund H, Olcen 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. doi: 10.1111/j.1600-0463.2005.apm1130203.x.
- Stralin K, Tornqvist E, Kaltoft MS, Olcen P, Holmberg H. Etiologic diagnosis of adult bacterial pneumonia by culture and PCR applied to respiratory tract samples. J Clin Microbiol. 2006 Feb;44(2):643-5. doi: 10.1128/JCM.44.2.643-645.2006.
- Dagan R, Shriker O, Hazan I, Leibovitz E, Greenberg D, Schlaeffer F, Levy R. Prospective study to determine clinical relevance of detection of pneumococcal DNA in sera of children by PCR. J Clin Microbiol. 1998 Mar;36(3):669-73. doi: 10.1128/JCM.36.3.669-673.1998.
- Kee C, Palladino S, Kay I, Pryce TM, Murray R, Rello J, Gallego M, Lujan M, Munoz-Almagro C, Waterer GW. Feasibility of real-time polymerase chain reaction in whole blood to identify Streptococcus pneumoniae in patients with community-acquired pneumonia. Diagn Microbiol Infect Dis. 2008 May;61(1):72-5. doi: 10.1016/j.diagmicrobio.2007.12.011. Epub 2008 Jan 24.
- 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.
- Harris KA, Turner P, Green EA, Hartley JC. Duplex real-time PCR assay for detection of Streptococcus pneumoniae in clinical samples and determination of penicillin susceptibility. J Clin Microbiol. 2008 Aug;46(8):2751-8. doi: 10.1128/JCM.02462-07. Epub 2008 Jun 18.
- Ho PL, Wong RC, Chow FK, Cheung MY, Wong SS, Yam WC, Que TL. Application of a multiplex pbp2b and pbp2x PCR for prediction of penicillin resistance in Streptococcus pneumoniae. J Antimicrob Chemother. 2004 May;53(5):890-1. doi: 10.1093/jac/dkh216. Epub 2004 Apr 8. No abstract available.
- Fukushima KY, Yanagihara K, Hirakata Y, Sugahara K, Morinaga Y, Kohno S, Kamihira S. Rapid identification of penicillin and macrolide resistance genes and simultaneous quantification of Streptococcus pneumoniae in purulent sputum samples by use of a novel real-time multiplex PCR assay. J Clin Microbiol. 2008 Jul;46(7):2384-8. doi: 10.1128/JCM.00051-08. Epub 2008 May 7.
- 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. doi: 10.1007/BF03260015.
- Normann E, Gnarpe J, Gnarpe H, Wettergren B. Chlamydia pneumoniae in children attending day-care centers in Gavle, Sweden. Pediatr Infect Dis J. 1998 Jun;17(6):474-8. doi: 10.1097/00006454-199806000-00007.
- O'Brien KL, Nohynek H; World Health Organization Pneumococcal Vaccine Trials Carriage Working Group. Report from a WHO Working Group: standard method for detecting upper respiratory carriage of Streptococcus pneumoniae. Pediatr Infect Dis J. 2003 Feb;22(2):e1-11. doi: 10.1097/01.inf.0000049347.42983.77. Erratum In: Pediatr Infect Dis J. 2011 Feb;30(2):185.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
March 23, 2009
First Submitted That Met QC Criteria
March 23, 2009
First Posted (Estimate)
March 24, 2009
Study Record Updates
Last Update Posted (Estimate)
February 25, 2016
Last Update Submitted That Met QC Criteria
February 24, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHEO-ID-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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