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A randomised trial of empiric broad-spectrum antibiotics and invasive diagnostic techniques in the setting of Ventilator-Associated Pneumonia
ISRCTN ISRCTN51767272
DOI 10.1186/ISRCTN51767272
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised trial of empiric broad-spectrum antibiotics and invasive diagnostic techniques in the setting of Ventilator-Associated Pneumonia
Scientific title
Acronym VAP
Serial number at source MCT-50377
Study hypothesis To evaluate whether the use of two empiric broad-spectrum antibiotics and invasive diagnostic techniques will improve clinical resolution, decrease length of stay and reduce mortality of critically ill patients with a clinical suspicion of late Ventilator-Associated Pneumonia (VAP).
Lay summary
Ethics approval Ethics approval received from the Queen's University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board on the 12th October 1999.
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Clinical suspicion of ventilator associated pneumonia in critically ill patients
Participants - inclusion criteria 1. Adult patients greater than or equal to 16 years old, either sex
2. Greater than 96 hours in the Intensive Care Unit (ICU)
3. Mechanically ventilated (greater than or equal to 48 hours)
4. Develops a clinical suspicion of pneumonia while ventilated
Participants - exclusion criteria 1. Unstable candidate for bronchoscopy as defined by the bronchoscopist
2. Patients not expected to survive greater than 72 hours or anticipate withdrawing treatments within 72 hours from the point of randomisation
3. Known or suspected history of anaphylaxis to penicillins, cephalosporins, carbapenems, meropenem or ciprofloxacin
4. Women who are pregnant or lactating
5. Patients already infected or colonised (respiratory tract only) with an organism not sensitive to study drugs
6. Patients already infected with pseudomonas species
7. Already on study drugs
8. Immunocompromised (post-organ transplantation, Human Immunodeficiency Virus [HIV], neutropenic [less than 1000 absolute neutrophils], corticosteroids [greater than 20 mg/day of prednisone or equivalent for more than 6 months])
9. Prior randomisation in this study
10. Enrolment in other interventional study
Anticipated start date 01/05/2000
Anticipated end date 30/09/2004
Status of trial Completed
Patient information material
Target number of participants 740
Interventions Patients will undergo bronchoscopy with bronchoalveolar lavage or endotracheal aspirates. Following sampling patients will be randomised again to receive either meropenem and ciprofloxacin or meropenem alone.
Primary outcome measure(s) Mortality at 28 days.
Secondary outcome measure(s) 1. Duration of stay in ICU
2. Adjudicated diagnosis of pneumonia
3. Clinical and microbiological response to treatment
4. Adequacy of initial treatment
5. Emergence of resistant organisms
6. Candida colonization and infection
7. Multiple organ dysfunction
8. Duration of mechanical ventilation
9. Hospital length of stay
10. Antibiotic use and costs of care
Sources of funding 1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50377)
2. Physician Services Inc. (PSI) (Canada)
3. Bayer (Canada)
4. AstraZeneca (Canada)
Trial website
Publications Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17182987
Contact name Dr  Daren Keith  Heyland
  Address Kingston General Hospital
76 Stuart St
Angada 4 Rm 5-416
  City/town Kingston
  Zip/Postcode K7L 2V7
  Country Canada
  Tel +1 613 549 6666 ext. 3339
  Fax +1 613 548 1351
  Email dkh2@post.queensu.ca
Sponsor Queen’s University (Canada)
  Address Fleming Hall
Jemmett Wing
  City/town Kingston
  Zip/Postcode K7L 2V7
  Country Canada
  Tel +1 613 533 6081
  Fax +1 613 533 6806
  Email marlins@post.queensu.ca
  Sponsor website: http://www.queensu.ca/homepage/
Date applied 09/09/2005
Last edited 11/12/2007
Date ISRCTN assigned 09/09/2005
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