Contact information
Type
Scientific
Primary contact
Dr Daren Keith Heyland
ORCID ID
Contact details
Kingston General Hospital
76 Stuart St
Angada 4 Rm 5-416
Kingston
K7L 2V7
Canada
+1 613 549 6666 ext. 3339
dkh2@post.queensu.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-50377
Study information
Scientific title
Acronym
VAP
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).
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Clinical suspicion of ventilator associated pneumonia in critically ill patients
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Broad-spectrum antibiotics
Primary outcome measures
Mortality at 28 days.
Secondary outcome measures
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
Overall trial start date
01/05/2000
Overall trial end date
30/09/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
740
Participant 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
Recruitment start date
01/05/2000
Recruitment end date
30/09/2004
Locations
Countries of recruitment
Canada
Trial participating centre
Kingston General Hospital
Kingston
K7L 2V7
Canada
Sponsor information
Organisation
Queens University (Canada)
Sponsor details
Fleming Hall
Jemmett Wing
Kingston
K7L 2V7
Canada
+1 613 533 6081
marlins@post.queensu.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50377)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Physician Services Inc. (PSI) (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bayer (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AstraZeneca (Canada)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
-
Results
A randomized trial of diagnostic techniques for ventilator-associated pneumonia., N. Engl. J. Med., 2006, 355, 25, 2619-2630, doi: 10.1056/NEJMoa052904.