Trial · NCT01345929
Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis
NCT01345929, Phase 3, Completed, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2015-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis. Trials, record NCT01345929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01345929
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis
- NCT number
- NCT01345929
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 558 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Complicated Urinary Tract Infection, Pyelonephritis
- Interventions
- CXA-201, Levofloxacin
- First posted
- 2011-05-02
- Last updated
- 2018-10-25
- Results first posted
- 2015-01-15
- Limitations and caveats
Two identical P3 protocols were initiated (NCT01345929 and NCT01345955) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. These analyses are presented here.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population | Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) | |
| Secondary | The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population. | Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population | Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) | mMITT: Treated subjects, with baseline pathogen. | percentage of subjects | NUMBER |
| SECONDARY | The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population. | Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) | ME: Treated patients, with baseline pathogen, complied with protocol. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population | CXA-201 as Treatment for cUTI | 76.9 | percentage of subjects | ||
The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population | Levofloxacin as Treatment for cUTI | 68.4 | percentage of subjects | ||
| The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population. | CXA-201 as Treatment for cUTI | 83.3 | percentage of subjects | ||
| The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population. | Levofloxacin as Treatment for cUTI | 75.4 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CXA-201 as Treatment for cUTI | 533 | |
| Overall Study | STARTED | Levofloxacin as Treatment for cUTI | 535 | |
| Overall Study | COMPLETED | CXA-201 as Treatment for cUTI | 512 | |
| Overall Study | COMPLETED | Levofloxacin as Treatment for cUTI | 516 | |
| Overall Study | NOT COMPLETED | CXA-201 as Treatment for cUTI | 21 | |
| Overall Study | NOT COMPLETED | Levofloxacin as Treatment for cUTI | 19 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | CXA-201 as Treatment for cUTI | 7 | 533 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Levofloxacin as Treatment for cUTI | 6 | 535 | |
| other | Constipation | Gastrointestinal disorders | CXA-201 as Treatment for cUTI | 21 | 533 | |
| other | Constipation | Gastrointestinal disorders | Levofloxacin as Treatment for cUTI | 17 | 535 | |
| other | Diarrhoea | Gastrointestinal disorders | CXA-201 as Treatment for cUTI | 10 | 533 | |
| other | Diarrhoea | Gastrointestinal disorders | Levofloxacin as Treatment for cUTI | 23 | 535 | |
| other | Nausea | Gastrointestinal disorders | CXA-201 as Treatment for cUTI | 15 | 533 | |
| other | Nausea | Gastrointestinal disorders | Levofloxacin as Treatment for cUTI | 9 | 535 | |
| other | Vomiting | Gastrointestinal disorders | CXA-201 as Treatment for cUTI | 6 | 533 | |
| other | Vomiting | Gastrointestinal disorders | Levofloxacin as Treatment for cUTI | 6 | 535 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CXA-201 as Treatment for cUTI | ||
| Total, all-cause mortality | Levofloxacin as Treatment for cUTI | ||
| Total, other adverse events | CXA-201 as Treatment for cUTI | 108 | 533 |
| Total, other adverse events | Levofloxacin as Treatment for cUTI | 101 | 535 |
| Total, serious adverse events | CXA-201 as Treatment for cUTI | 15 | 533 |
| Total, serious adverse events | Levofloxacin as Treatment for cUTI | 18 | 535 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| CXA-201 as Treatment for cUTI vs Levofloxacin as Treatment for cUTI: serious adverse events |
Source Trial comparisons
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/NCT01345929
GET https://conductscience.org/api/trials/v1/NCT01345929/events?page=2