Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support

• ClinicalTrials.gov Identifier: NCT00050401
• Recruitment Status: Completed
• First Posted: December 10, 2002
• Last Update Posted: September 1, 2017
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: December 8, 2002
• First Posted Date: December 10, 2002
• Last Update Posted Date: September 1, 2017
• Study Start Date: July 2002
• Actual Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support
• Official Title: Impact of Aggressive Empiric Antibiotic Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-associated Pneumonia
• Brief Summary: The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pneumonia

Intervention

• Drug: MERREM I.V. 2g as a 3 hour infusion every 8 hours
• Drug: vancomycin I.V. 1 g every 12 hours
• Drug: tobramycin I.V. 5 mg/kg every 24 hours
• Drug: MERREM I.V. 1g as a 30 minute infusion every 8 hours
• Drug: MERREM I.V. 500 mg as a 3 hour infusion every 8 hours

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 500
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2004
• Actual Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Onset or exacerbation of pneumonia at least 72 hours after admission to an acute care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility
• Diagnosis of hospital-acquired pneumonia requiring mechanical ventilatory support
• Patient or Patient's legal guardian must sign written informed consent for study participation, pretreatment, and Day 7 bronchoscopy

Exclusion Criteria:

• Patients with hospital-acquired pneumonia caused by pathogens resistant to MERREM
• Patients with allergies to cephalosporins, penicillins and carbapenems
• Patients taking anticonvulsant therapy for a known seizure disorder
• Patients with lung cancer
• Patients with cystic fibrosis, acquired immune deficiency syndrome (AIDS), neutropenia, active tuberculosis, or patients taking immunosuppressive therapy in preparation for or following an organ transplant.
• Patients who are pregnant or breast feeding
• Patients who are unlikely to survive
• Patients with certain infections in another area requiring treatment with additional antibiotics
• Patients with other underlying conditions that would make it difficult to interpret response to study drug.
• Patients who have been part of another clinical study 30 days before entry into this study.
• Patients with hypotension (systolic BP < 85mmHg) or acidosis (arterial pH <7.25 or serum bicarbonate <15 mg/dl) despite attempts at fluid resuscitation
• Patients with profound hypoxia

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00050401
• Other Study ID Numbers: 3591IL/0082
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pfizer
• Verification Date: August 2017