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Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment

NCT01104662 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2018-09-05

Study results available
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Summary

This is a multicenter, randomized, evaluator-blinded, comparator-controlled study. Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of renal impairment (creatinine clearance \[CLcr\] 30 - 50 milliliters per minute \[mL/min\] \[moderate impairment\] and \<30 mL/min \[severe impairment\]) and by type of infection (bacteremia and complicated skin and skin structure infections \[cSSSI\]) to create 4 cohorts defined as follows:

* Cohort 1: Bacteremia and CLcr \<30 mL/min
* Cohort 2: Bacteremia and CLcr 30 - 50 mL/min
* Cohort 3: cSSSI and CLcr \<30 mL/min
* Cohort 4: cSSSI and CLcr 30 - 50 mL/min

Participants will be treated and evaluated for safety and microbiological and clinical efficacy in accordance with their type of infection and degree of renal impairment. Peak and trough samples will be collected to assess exposure to daptomycin for participants on Day 1 and following the 5th dose.

Conditions

  • Complicated Skin and Skin Structure Infections
  • S. Aureus Bacteremia
  • Renal Impairment

Interventions

DRUG

Vancomycin

DRUG

Daptomycin

DRUG

Semi-Synthetic Penicillin

Sponsors & Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Ellie Hershberger, Pharm.D. · Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-19
Primary Completion
2012-06-12
Completion
2012-06-12

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01104662 on ClinicalTrials.gov