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NCT01168713 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

A Phase 2 study, sponsored by Melinta Therapeutics.

Completed
Registry status
Phase 2
Development phase
132
Enrollment target

NCT01168713: Completed Phase 2 study, sponsored by Melinta Therapeutics.

NCT01168713 is a Phase 2 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01168713, a Phase 2 study, has completed, sponsored by Melinta Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
132 participants
Enrollment target

Study Summary

Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.

Primary Outcome

Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment

Interventions

  • DRUG Levofloxacin
  • DRUG CEM-101

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2010-08
Est. Completion 2011-07
Phase Phase 2
Melinta Therapeutics

31 total trials

What the finished NCT01168713 record still lists

NCT01168713 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Levofloxacin is the first listed.

NCT01168713 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01168713 about?

NCT01168713 is a clinical study titled "Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia". Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.

What is the current status of trial NCT01168713?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2010-08. Estimated completion is 2011-07.

What interventions are being tested in trial NCT01168713?

The interventions under investigation include: Levofloxacin (DRUG), CEM-101 (DRUG).

Who is sponsoring clinical trial NCT01168713?

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

How this trial's enrollment target compares

Where NCT01168713's enrollment target sits among peer trials

132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01168713, the US trial registry maintained by the National Library of Medicine. NCT01168713 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.