NCT01970371

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

A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Achaogen, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	plazomicin
DRUG	colistin
DRUG	meropenem
DRUG	tigecycline
DRUG	antibiotic of Investigator's choice

Timeline

• Start date: 2014-09-16
• Primary completion: 2016-08-18
• Completion: 2016-09-15
• First posted: 2013-10-28
• Last updated: 2018-10-16
• Results posted: 2018-10-16