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Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections

NCT01281462 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2014-02-03

No results posted yet for this study

Summary

This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.

Conditions

Interventions

DRUG

Ceftaroline fosamil and NXL104 (q8h)

600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);

DRUG

Ceftaroline fosamil and NXL104 (q12h)

600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);

DRUG

Doripenem

500 mg doripenem IV q8h;

DRUG

Placebo

On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-03-31
Completion
2012-07-31

Countries

  • United States
  • Bulgaria
  • Germany
  • Lebanon
  • Poland
  • Russia
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
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 NCT01281462 on ClinicalTrials.gov