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NCT01756339 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Community-acquired Bacterial Pneumonia, sponsored by Melinta Therapeutics.

Completed
Registry status
Phase 3
Development phase
860
Enrollment target
20
Study locations

NCT01756339 is a Phase 3 study of Community-acquired Bacterial Pneumonia that has completed, run by Melinta Therapeutics. The registered enrollment target is 860 participants. The trial reports 20 study locations across 9 states.

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The verdict

NCT01756339, a Phase 3 study of Community-acquired Bacterial Pneumonia, has completed, sponsored by Melinta Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
860 participants
Enrollment target
20
Study locations

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.

Interventions

  • DRUG Moxifloxacin
  • DRUG Solithromycin
  • OTHER Placebo to match solithromycin

Study Locations (20)

California

  • - Glendale
  • - Los Angeles
  • - Mission Hills
  • - Oxnard
  • - Pasadena
  • - Sylmar
  • - Torrance

Florida

  • - DeBary
  • - DeLand
  • - Miami
  • - Miami
  • - Saint Cloud
  • - Tampa

Georgia

  • - Duluth

Massachusetts

  • - New Bedford

Montana

  • - Butte

Ohio

  • - Columbus

Pennsylvania

  • - Downingtown

South Carolina

  • - Summerville

Trial Details

FieldValue
Enrollment Target 860 participants
Start Date 2012-12
Est. Completion 2014-10
Phase Phase 3

Sponsor

Melinta Therapeutics

31 total trials

What the Registry Record Tells You About NCT01756339

The ClinicalTrials.gov registry entry for NCT01756339 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 860 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Melinta Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Community-acquired Bacterial Pneumonia appearing as the primary indexed condition, and to 3 interventions - of which Moxifloxacin is the first listed.

NCT01756339 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01756339 about?

NCT01756339 is a clinical study titled "Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia". This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

What is the current status of trial NCT01756339?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 860 participants. The study started on 2012-12. Estimated completion is 2014-10.

What conditions does trial NCT01756339 study?

This clinical trial studies the following conditions: Community-acquired Bacterial Pneumonia.

What interventions are being tested in trial NCT01756339?

The interventions under investigation include: Moxifloxacin (DRUG), Solithromycin (DRUG), Placebo to match solithromycin (OTHER).

Who is sponsoring clinical trial NCT01756339?

This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01756339 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.