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Phase II Study of Oral Nafithromycin in CABP

NCT02903836 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2019-12-20

Study results available
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Summary

Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults

Conditions

  • Community-Acquired Bacterial Pneumonia (CABP)

Interventions

DRUG

Nafithromycin 800 mg 3 days

DRUG

Nafithromycin 800 mg 5 days

DRUG

Moxifloxacin 400 mg

Sponsors & Collaborators

  • ACM

    collaborator UNKNOWN

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Ashima Bhatia, MD PDCR · Wockhardt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-18
Primary Completion
2017-07-31
Completion
2017-07-08

Countries

  • United States

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 NCT02903836 on ClinicalTrials.gov