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A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)

NCT01970371 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2018-10-16

Study results available
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Summary

This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in the treatment of patients with bloodstream infection (BSI), hospital acquired bacterial pneumonia (HABP), or ventilator-associated bacterial pneumonia (VABP) due to CRE. An additional cohort of patients with BSI, HABP, VABP, complicated urinary tract infection (cUTI), or acute pyelonephritis (AP) due to CRE, not eligible for inclusion in the other cohort, were enrolled into a single arm (Cohort 2) and treated with plazomicin-based therapy. Therapeutic drug management (TDM) was used to help ensure that plazomicin exposures lie within an acceptable range of the target mean steady-state area under the curve (AUC).

Conditions

  • Bloodstream Infections (BSI) Due to CRE
  • Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
  • Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE
  • Complicated Urinary Tract Infection (cUTI) Due to CRE
  • Acute Pyelonephritis (AP) Due to CRE

Interventions

DRUG

plazomicin

DRUG

colistin

DRUG

meropenem

DRUG

tigecycline

DRUG

antibiotic of Investigator's choice

Sponsors & Collaborators

Principal Investigators

  • Lynn E Connolly, MD, PhD · Achaogen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-16
Primary Completion
2016-08-18
Completion
2016-09-15

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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 NCT01970371 on ClinicalTrials.gov