Trial · NCT01168713
Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
NCT01168713, Phase 2, Completed, Melinta Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia. Trials, record NCT01168713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01168713
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
- NCT number
- NCT01168713
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 132 participants, actual
- Lead sponsor
- Melinta Therapeutics, Inc.
- Conditions
- Community-Acquired Bacterial Pneumonia
- Interventions
- Levofloxacin, CEM-101
- First posted
- 2010-07-23
- Last updated
- 2017-03-03
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit | 5 to 10 days after the last dose of study drug | 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 |
| Primary | Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit | 5 to 10 days after the last dose of study drug | 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 |
| Secondary | By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT) | 5 days of study drug treatment | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen. |
| Secondary | By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit | 5 to 10 days after the last dose of study drug | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
| Secondary | By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT) | 5 days of study drug treatment | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
| Secondary | By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit | 5 to 10 days after the last dose of study drug | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
| Secondary | Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT) | 5 days of study drug treatment | Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP |
| Secondary | Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT) | 5 days of study drug treatment | Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP |
| Secondary | Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT) | 5 days of study drug treatment | Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP |
| Secondary | Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT) | 5 days of study drug treatment | Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23507282 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01168713
GET https://conductscience.org/api/trials/v1/NCT01168713/registered