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Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

NCT01168713 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2017-03-03

No results posted yet for this study

Summary

Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.

Conditions

  • Community-Acquired Bacterial Pneumonia

Interventions

DRUG

Levofloxacin

Levofloxacin once daily for 5 days: Levofloxacin 750 mg PO Days 1-5

DRUG

CEM-101

CEM-101 once daily for 5 days: CEM-101 800 mg PO Day 1 CEM-101 400 mg PO Days 2-5

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Canada

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 NCT01168713 on ClinicalTrials.gov