A randomised trial of empiric broad-spectrum antibiotics and invasive diagnostic techniques in the setting of Ventilator-Associated Pneumonia

ISRCTN ISRCTN51767272
DOI https://doi.org/10.1186/ISRCTN51767272
Secondary identifying numbers MCT-50377
Submission date
09/09/2005
Registration date
09/09/2005
Last edited
11/12/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daren Keith Heyland
Scientific

Kingston General Hospital
76 Stuart St
Angada 4 Rm 5-416
Kingston
K7L 2V7
Canada

Phone +1 613 549 6666 ext. 3339
Email dkh2@post.queensu.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymVAP
Study objectivesTo 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(s)Ethics approval received from the Queen's University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board on the 12th October 1999.
Health condition(s) or problem(s) studiedClinical suspicion of ventilator associated pneumonia in critically ill patients
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Broad-spectrum antibiotics
Primary outcome measureMortality at 28 days.
Secondary outcome measures1. 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 study start date01/05/2000
Completion date30/09/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants740
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/05/2000
Date of final enrolment30/09/2004

Locations

Countries of recruitment

  • Canada

Study participating centre

Kingston General Hospital
Kingston
K7L 2V7
Canada

Sponsor information

Queen’s University (Canada)
University/education

Fleming Hall
Jemmett Wing
Kingston
K7L 2V7
Canada

Phone +1 613 533 6081
Email marlins@post.queensu.ca
Website http://www.queensu.ca/homepage/
ROR logo "ROR" https://ror.org/02y72wh86

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50377)

No information available

Physician Services Inc. (PSI) (Canada)

No information available

Bayer (Canada)

No information available

AstraZeneca (Canada)
Government organisation / For-profit companies (industry)
Alternative name(s)
AstraZeneca PLC, Pearl Therapeutics
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 21/12/2006 Yes No