Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia
Intervention: 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 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca
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.
Clinical Details
Official title: Impact of Aggressive Empiric Antibiotic Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-Associated Pneumonia
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Phoenix, Arizona, United States
Newark, Delaware, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Lebanon, New Hampshire, United States
Albany, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Cincinnati, Ohio, United States
San Antonio, Texas, United States
Additional Information
Starting date: November 2002
Last updated: June 1, 2006
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