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

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MERREM I.V. 2g as a 3 hour infusion every 8 hours
vancomycin I.V. 1 g every 12 hours
tobramycin I.V. 5 mg/kg every 24 hours
MERREM I.V. 1g as a 30 minute infusion every 8 hours
MERREM I.V. 500 mg as a 3 hour infusion every 8 hours
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring ventilator-associated, nosocomial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 8, 2002
Last Updated
August 31, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00050401
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
ventilator-associated, nosocomial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MERREM I.V. 2g as a 3 hour infusion every 8 hours
Intervention Type
Drug
Intervention Name(s)
vancomycin I.V. 1 g every 12 hours
Intervention Type
Drug
Intervention Name(s)
tobramycin I.V. 5 mg/kg every 24 hours
Intervention Type
Drug
Intervention Name(s)
MERREM I.V. 1g as a 30 minute infusion every 8 hours
Intervention Type
Drug
Intervention Name(s)
MERREM I.V. 500 mg as a 3 hour infusion every 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Newark
State/Province
Delaware
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Albany
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Stony Brook
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

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

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