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A Polymerase Chain Reaction (PCR) - Based Method to Improve Antibiotic Prescribing for Pneumonia
This study is not yet open for participant recruitment.
Verified by Children's Hospital of Eastern Ontario, March 2009
First Received: March 23, 2009   No Changes Posted
Sponsors and Collaborators: Children's Hospital of Eastern Ontario
The Physicians' Services Incorporated Foundation
Information provided by: Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00867841
  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: Ecologic or Community, 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

Biospecimen Description:

nasopharyngeal swabs blood samples (for pneumococcal PCR)


Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867841

Contacts
Contact: Jeffrey Pernica, MD (613) 737 7600 ext 2651 jpernica@cheo.on.ca

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:
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. 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.
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. Epub 2004 Aug 13.
Juvén 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.
Muñoz-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.
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. 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.
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.
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. 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.
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.
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.
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. 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.
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. Epub 2006 Mar 7.
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.
Strålin K, Törnqvist E, Kaltoft MS, Olcén 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.
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.
Kee C, Palladino S, Kay I, Pryce TM, Murray R, Rello J, Gallego M, Lujan M, Muñoz-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. 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. 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. 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. 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. 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.
Normann E, Gnarpe J, Gnarpe H, Wettergren B. Chlamydia pneumoniae in children attending day-care centers in Gävle, Sweden. Pediatr Infect Dis J. 1998 Jun;17(6):474-8.
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. Review.

Responsible Party: Children's Hospital of Eastern Ontario/University of Ottawa ( Jeffrey Pernica )
Study ID Numbers: CHEO-ID-001
Study First Received: March 23, 2009
Last Updated: March 23, 2009
ClinicalTrials.gov Identifier: NCT00867841     History of Changes
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

Study placed in the following topic categories:
Anti-Infective Agents
Anti-Bacterial Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Mycoplasma Infections
Pleuropneumonia
Pneumonia

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

ClinicalTrials.gov processed this record on August 25, 2009