Polymyxin B Monotherapy vs Combination Therapy in Critically Ill Patients With Multi-drug Resistant Pathogens

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of polymyxin B as monotherapy versus a combined polymyxin B-carbapenem therapy against multidrug-resistant (MDR) gram negative infections. The investigators intend to evaluate if this synergistic drug regimen correlates with improved outcomes against gram-negative infections in critically ill patients including: better clinical resolution, reduced length of stay at hospital, reduced length of stay at the intensive care unit, and less recurrence of infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Puerto Rico
• Treatments: Imipenem; Polymyxin B; Polymyxins

Criteria

Inclusion Criteria:

• 21 years or older admitted to the Intensive Care Unit of the Puerto Rico Trauma Hospital ° Consent form signed,

• Clinical and microbiological evidence of a MDR infection related to HAP, VAP, cUTI or BSI.

• The pathogen should be resistant to almost all antibiotics, AND/OR intermediate resistant to some of the antibiotics, AND/OR susceptible only to a class of antibiotic (i.e. aminoglycosides which are NOT recommended as monotherapy), AND/OR the clinician decision is to start the patient on polymyxin B due to severity of the infection.

• Patient with a diagnosis of MDR infection, who have not received antibiotics at all; OR if received would be < 72 hours with polymyxin B or imipenem at/or after the diagnosis of MDR AND/OR at the time of randomization

• Have a life expectancy of > 24 hours according to the attending physician's criteria.

Exclusion Criteria:

• Pregnant woman

• Prisoners

• Severe hepatic failure (defined by serum conjugated bilirubin > 3 mg/dL)

• End-stage renal disease requiring hemodialysis

• Hypersensitivity to any study drug

• Septic shock at the moment of randomization

• Died within 48 hours of starting the study