MedTrace Logo

Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia

NCT02679573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 860

Last updated 2020-02-27

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to moxifloxacin in the treatment of adult patients with community-acquired pneumonia.

Conditions

  • Community Acquired Bacterial Pneumonia

Interventions

DRUG

Delafloxacin

Antibacterial agent, 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total

DRUG

Moxifloxacin

Antibacterial Agent, 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total

DRUG

Linezolid

Antibacterial Agent, at local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sue Cammarata, MD · Melinta Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-14
Primary Completion
2018-07-31
Completion
2018-08-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Colombia
  • Dominican Republic
  • Georgia
  • Germany
  • Hungary
  • Latvia
  • Peru
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovenia
  • South Africa
  • Spain
  • Ukraine

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 NCT02679573 on ClinicalTrials.gov