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22 May 2012
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| [ Print-friendly version ] |
| A randomised trial of empiric broad-spectrum antibiotics and invasive diagnostic techniques in the setting of Ventilator-Associated Pneumonia |
| ISRCTN | ISRCTN51767272 |
| ClinicalTrials.gov identifier | |
| 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
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| 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 |
| 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 |
| 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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| © 2012 ISRCTN unless otherwise stated. | |
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