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

NCT03159078 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-02-08

No results posted yet for this study

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.

Conditions

  • Trauma
  • Resistant Infection
  • Critical Illness

Interventions

DRUG

Polymyxin B

Comparison of Poly B monotherapy vs Polymyxin B plus carbapenem in MDR infections

Sponsors & Collaborators

  • University of Puerto Rico

    lead OTHER

Principal Investigators

  • Juan M Maldonado Lozada, PharmD · School of Pharmacy, University of Puerto Rico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-25
Primary Completion
2019-12-01
Completion
2019-12-01
FDA Drug
Yes

Countries

  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

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 NCT03159078 on ClinicalTrials.gov