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Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

NCT01968733 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 863

Last updated 2017-03-03

No results posted yet for this study

Summary

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Conditions

  • Community-acquired Bacterial Pneumonia

Interventions

DRUG

Solithromycin

DRUG

Moxifloxacin

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Brian D Jamieson, MD · Melinta Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Georgia
  • Germany
  • Guatemala
  • Hungary
  • Latvia
  • Malaysia
  • Netherlands
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Ukraine

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 NCT01968733 on ClinicalTrials.gov