Overview

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