Impact of Aggressive Empiric Antibiotic Therapy and Duration of Therapy on the Emergence of Antimicrobial Resistance during the Treatment of Hospitalized Subjects with Pneumonia Requiring Mechanical Ventilation - VABP

niversity of Florida Board of Trustees0 sites480 target enrollmentOctober 18, 2013

ConditionsPneumonia MedDRA version: 14.1Level: PTClassification code 10060946Term: Pneumonia bacterialSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pneumonia
Sponsor: niversity of Florida Board of Trustees
Enrollment: 480
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 18, 2013

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity of Florida Board of Trustees

Eligibility Criteria

Inclusion Criteria

•1\. Provision of written informed consent by the subject or subject's legal representative.
•2\. Hospitalized males or females, 18 years or older, with respiratory failure requiring mechanical ventilation and clinical suspicion of HABP, HCAP or VABP.
•3\. 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 (HCAP definition: and as defined in Inclusion criteria 6, 7, and 8\).
•4\. Women of childbearing potential may be entered if their pregnancy test (urine or serum) is negative, and they are instructed to abstain from sexual intercourse for the duration of the study, or contraceptive measures are used until all follow\-up procedures are complete. Medically acceptable contraceptives include: (1\) surgical sterilization, (2\) approved hormonal contraceptives as advised by your study doctor (such as birth control pills, Depo\-Provera, or Lupron Depot), (3\) two barrier methods (such as a condom or diaphragm) used with a spermicide, or (4\) an intrauterine device (IUD).
•5\. Subjects who have received previous antibacterial therapy within 14 days of pre\-treatment bronchoscopy entry may be entered only if the subject has not responded clinically (as defined in Inclusion Criteria 6, 7, and 8\).
•6\. Patients should have the following clinical findings that support a diagnosis of HABP/VABP/HCAP:
•\-Documented fever, defined as an oral or tympanic temperature greater than or equal to 38\.0 degrees Celsius (100\.4 degrees Fahrenheit), or a core temperature greater than or equal to 38\.3 degrees Celsius (101 degrees Fahrenheit) or hypothermia, defined as a core body temperature of less than 35 degrees Celsius (95\.2 degrees Fahrenheit); axillary temperatures are not recommended.
•\-An elevated total peripheral white blood cell (WBC) count (WBC greater than 10000/mm3\); or greater than 15 percent immature neutrophils (bands), regardless of total peripheral WBC count; or leukopenia with total WBC less than 4500/mm3\.
•\-New onset of expectorated or suctioned respiratory secretions characterized by purulent appearance indicative of bacterial pneumonia.
•In addition, patients with HABP should have at least one of the following present at enrollment:

Exclusion Criteria

•1\. Subjects with pneumonia caused by pathogens resistant to meropenem (MIC \>16?g/ml) or a prior meropenem therapy failure.
•2\. Subjects with contra\-indications to ANY study medication, in particular with known or suspected allergy or hypersensitivity. This is inclusive of type I hypersensitivity (e.g., anaphylaxis) to cephalosporins, penicillins, monobactams, or carbapenems, and to vancomycin or linezolid.
•3\. Women who are pregnant or lactating.
•4\. Subjects taking anticonvulsant medications for a known seizure disorder.
•5\. Subjects with known or suspected community acquired bacterial pneumonia (CABP) or viral pneumonia; or Subjects with acute exacerbation of chronic bronchitis without evidence of pneumonia.
•6\. Subjects with primary lung cancer or another malignancy metastatic to the lungs.
•7\. Subjects who were previously enrolled in this study.
•8\. Subjects who have had an investigational drug or have used an investigational device within 30 days prior to entering the study.
•9\. Subjects with another focus of infection requiring concurrent antibiotics (e.g. other broad spectrum agents or those agents providing gram negative coverage) that would interfere with evaluation of the response to study drug.
•10\. Subjects with cystic fibrosis, acquired immune deficiency syndrome (AIDS) with a CD4 lymphocyte count \<200 cells/µl, neutropenia (absolute neutrophil count \<500 cells/ml), known or suspected active tuberculosis.