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

Impact of Aggressive Empiric Antibiotic Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Ventilator-associated Pneumonia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00050401

Enrollment

500

Registered

2002-12-10

Start date

2002-07-31

Completion date

2004-09-30

Last updated

2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

ventilator-associated, nosocomial

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.

Interventions

DRUGMERREM I.V. 2g as a 3 hour infusion every 8 hours

DRUGvancomycin I.V. 1 g every 12 hours

DRUGtobramycin I.V. 5 mg/kg every 24 hours

DRUGMERREM I.V. 1g as a 30 minute infusion every 8 hours

DRUGMERREM I.V. 500 mg as a 3 hour infusion every 8 hours

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026