Plain English Summary

Not provided at time of registration

Trial website

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

Queen’s 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

http://www.queensu.ca/homepage/

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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17182987

Publication citations

  1. Results

    A randomized trial of diagnostic techniques for ventilator-associated pneumonia., N. Engl. J. Med., 2006, 355, 25, 2619-2630, doi: 10.1056/NEJMoa052904.

Editorial Notes