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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00050401
First received: December 8, 2002
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pneumonia
 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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Aggressive Empiric Antibiotic Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-associated Pneumonia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Estimated Enrollment: 500
Study Start Date: July 2002
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050401

Locations
United States, Arizona
Phoenix, Arizona, United States
United States, Delaware
Newark, Delaware, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New York
Albany, New York, United States
New York, New York, United States
Stony Brook, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00050401     History of Changes
Other Study ID Numbers: 3591IL/0082
Study First Received: December 8, 2002
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
ventilator-associated
nosocomial

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
 Tobramycin
Vancomycin
Meropenem
Thienamycins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013