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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00050401
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : September 1, 2017
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2002
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050401


Locations
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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
Pfizer
More Information
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ClinicalTrials.gov Identifier: NCT00050401    
Other Study ID Numbers: 3591IL/0082
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Keywords provided by Pfizer:
ventilator-associated
nosocomial
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
 Infection
Vancomycin
Tobramycin
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents