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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51767272
Enrollment
740
Registered
2005-09-09
Start date
2000-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical suspicion of ventilator associated pneumonia in critically ill patients Respiratory Pneumonia

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 meropene

Sponsors

Queen?s University (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Mortality at 28 days.

Secondary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 8, 2026