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Clinical Trials to Reduce the Risk of Antimicrobial Resistance

NCT01570192 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2017-09-29

Study results available
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Summary

The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged infusion in combination with a parenteral aminoglycoside plus tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 - control arm).

Conditions

  • Bacterial Pneumonia

Interventions

DRUG

IV meropenem

Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).

DRUG

I.V. Meropenem

Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr). Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage

DRUG

Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h

a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)

DRUG

Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage.

Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.

DEVICE

tobramycin nebulization

tobramycin nebulization 600mg/day

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • George L Drusano, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-04-30
Completion
2015-04-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01570192 on ClinicalTrials.gov