Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00050401

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Antibiotics Pneumonia

Drug Information available for: Tobramycin Tobramycin sulfate Meropenem Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Estimated Enrollment:	500
Study Start Date:	November 2002

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

Study ID Numbers:	3591IL/0082
Study First Received:	December 8, 2002
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00050401 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

ventilator-associated
nosocomial

Additional relevant MeSH terms:

Anti-Infective Agents
Tobramycin
Infection
Pneumonia, Ventilator-Associated
Pharmacologic Actions
Anti-Bacterial Agents
Respiratory Tract Diseases

Respiratory Tract Infections
Lung Diseases
Meropenem
Therapeutic Uses
Vancomycin
Pneumonia
Cross Infection

ClinicalTrials.gov processed this record on February 09, 2010