Trial · NCT00921024
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
NCT00921024, Phase 2, 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. Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections. Trials, record NCT00921024. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00921024
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
- NCT number
- NCT00921024
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 129 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Complicated Urinary Tract Infection
- Interventions
- CXA-101, Ceftazidime
- First posted
- 2009-06-16
- Last updated
- 2018-10-18
- Results first posted
- 2015-01-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population | TOC; 6-9 days after last study drug administration | Microbiological response is eradication for each baseline pathogen |
| Primary | Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population. | TOC; 6-9 days after last study drug administration | Microbiological response is eradication for each baseline pathogen |
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 | Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population | TOC; 6-9 days after last study drug administration | mMITT: Treated patients, with baseline pathogen. | percentage of patients | NUMBER |
| PRIMARY | Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population. | TOC; 6-9 days after last study drug administration | ME: Treated patients, with baseline pathogen, complied with protocol. | percentage of patients | 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 |
|---|---|---|---|---|---|
| Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population | CXA-101 | 83.1 | 95% Confidence Interval 71.7 to 91.2 | percentage of patients | |
| Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population | Ceftazidime | 76.3 | 95% Confidence Interval 59.8 to 88.6 | percentage of patients | |
| Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population. | CXA-101 | 85.5 | 95% Confidence Interval 73.3 to 93.5 | percentage of patients | |
| Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population. | Ceftazidime | 92.6 | 95% Confidence Interval 75.7 to 99.1 | percentage of patients |
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-101 | 85 | |
| Overall Study | STARTED | Ceftazidime | 42 | |
| Overall Study | COMPLETED | CXA-101 | 81 | |
| Overall Study | COMPLETED | Ceftazidime | 39 | |
| Overall Study | NOT COMPLETED | CXA-101 | 4 | |
| Overall Study | NOT COMPLETED | Ceftazidime | 3 |
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 | Anaemia | Blood and lymphatic system disorders | CXA-101 | 1 | 85 | |
| other | Anaemia | Blood and lymphatic system disorders | Ceftazidime | 1 | 42 | |
| other | Vertigo | Ear and labyrinth disorders | CXA-101 | 0 | 85 | |
| other | Vertigo | Ear and labyrinth disorders | Ceftazidime | 1 | 42 | |
| other | Arteriosclerotic retinopathy | Eye disorders | CXA-101 | 0 | 85 | |
| other | Arteriosclerotic retinopathy | Eye disorders | Ceftazidime | 1 | 42 | |
| other | Retinal degeneration | Eye disorders | CXA-101 | 0 | 85 | |
| other | Retinal degeneration | Eye disorders | Ceftazidime | 1 | 42 | |
| other | Vision blurred | Eye disorders | CXA-101 | 0 | 85 | |
| other | Vision blurred | Eye disorders | Ceftazidime | 1 | 42 |
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-101 | ||
| Total, all-cause mortality | Ceftazidime | ||
| Total, other adverse events | CXA-101 | 33 | 85 |
| Total, other adverse events | Ceftazidime | 16 | 42 |
| Total, serious adverse events | CXA-101 | 1 | 85 |
| Total, serious adverse events | Ceftazidime | 0 | 42 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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-101 vs Ceftazidime: 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/NCT00921024
GET https://conductscience.org/api/trials/v1/NCT00921024/events?page=2