Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance

NCT01624246 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-04-07

No results posted yet for this study

Summary

To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).

Conditions

  • Augmented Renal Clearance (ARC)
  • Systemic Inflammatory Response Syndrome (SIRS)

Interventions

DRUG

Ceftaroline fosamil/Avibactam (CXL)

IV infusion of CXL (combination of ceftaroline fosamil \[600 mg\] plus avibactam \[600 mg\]) infused over 60 (± 5) minutes.

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Forest Laboratories

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States
  • Australia

Study Locations

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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 NCT01624246 on ClinicalTrials.gov