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 |
| Protocol serial number | MCT-50377 |
| Sponsor | Queens University (Canada) |
| Funders | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50377), Physician Services Inc. (PSI) (Canada), Bayer (Canada), AstraZeneca (Canada) |
- 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
Scientific
Kingston General Hospital
76 Stuart St
Angada 4 Rm 5-416
Kingston
K7L 2V7
Canada
| Phone | +1 613 549 6666 ext. 3339 |
|---|---|
| dkh2@post.queensu.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | VAP |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Broad-spectrum antibiotics |
| Primary outcome measure(s) | Mortality at 28 days. |
| Key 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 |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 740 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2000 |
| Date of final enrolment | 30/09/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
Kingston General Hospital
Kingston
K7L 2V7
Canada
K7L 2V7
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 21/12/2006 | Yes | No |
