MedTrace Logo

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

NCT01756339 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 860

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

OTHER

Placebo to match solithromycin

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Oldach, 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
2012-12-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Czechia
  • Dominican Republic
  • Ecuador
  • Estonia
  • Germany
  • Hungary
  • Latvia
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • South Africa
  • Spain

Study Locations

More Related Trials

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 NCT01756339 on ClinicalTrials.gov