Trial · NCT00690378
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
NCT00690378, Phase 2, Completed, Pfizer; results first posted 2018-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections. Trials, record NCT00690378. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00690378
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
- NCT number
- NCT00690378
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 137 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Complicated Urinary Tract Infection
- Interventions
- NXL104/ceftazidime, Imipenem/Cilastatin
- First posted
- 2008-06-04
- Last updated
- 2018-05-25
- Results first posted
- 2018-05-25
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit | 5 to 9 days post-therapy | Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL |
| Secondary | Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit | End of IV therapy (4 to 14 days) | Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required |
| Secondary | Clinical Outcome in CE Patients at the TOC Visit | 5 to 9 days post-therapy | Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required |
| Secondary | Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit | 4 to 6 weeks post-therapy | Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required |
| Secondary | Microbiological Outcome in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL |
| Secondary | Microbiological Outcome in ME Patients at the LFU Visit | 4 to 6 weeks post-therapy | Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL |
| Secondary | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL |
| Secondary | Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL |
| Secondary | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL |
| Secondary | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit | 5 to 9 days post-therapy | Participants | NUMBER | |
| SECONDARY | Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit | End of IV therapy (4 to 14 days) | Participants | NUMBER | |
| SECONDARY | Clinical Outcome in CE Patients at the TOC Visit | 5 to 9 days post-therapy | Participants | NUMBER | |
| SECONDARY | Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit | 4 to 6 weeks post-therapy | Participants | NUMBER | |
| SECONDARY | Microbiological Outcome in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Participants | NUMBER | |
| SECONDARY | Microbiological Outcome in ME Patients at the LFU Visit | 4 to 6 weeks post-therapy | Participants | NUMBER | |
| SECONDARY | Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Participants | NUMBER | |
| SECONDARY | Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Participants | NUMBER | |
| SECONDARY | Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Participants | NUMBER | |
| SECONDARY | Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit | End of IV therapy (4 to 14 days) | Participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit | NXL104/CAZ | 19 | Participants | ||
| Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit | Imipenem Cilastatin | 25 | Participants | ||
| Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit | NXL104/CAZ | 28 | Participants | ||
| Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit | Imipenem Cilastatin | 36 | Participants | ||
| Clinical Outcome in CE Patients at the TOC Visit | NXL104/CAZ | 24 | Participants | ||
| Clinical Outcome in CE Patients at the TOC Visit | Imipenem Cilastatin | 29 | Participants | ||
| Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit | NXL104/CAZ | 20 | Participants | ||
| Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit | Imipenem Cilastatin | 24 | Participants | ||
| Microbiological Outcome in ME Patients at the End of IV Therapy Visit | NXL104/CAZ | 25 | Participants | ||
| Microbiological Outcome in ME Patients at the End of IV Therapy Visit | Imipenem Cilastatin | 34 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NXL104/CAZ | 69 | |
| Overall Study | STARTED | Imipenem Cilastatin | 68 | |
| Overall Study | Treated | NXL104/CAZ | 68 | |
| Overall Study | Treated | Imipenem Cilastatin | 67 | |
| Overall Study | COMPLETED | NXL104/CAZ | 49 | |
| Overall Study | COMPLETED | Imipenem Cilastatin | 54 | |
| Overall Study | NOT COMPLETED | NXL104/CAZ | 20 | |
| Overall Study | NOT COMPLETED | Imipenem Cilastatin | 14 |
Source ClinicalTrials.gov
Adverse events46
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 | Constipation | Gastrointestinal disorders | NXL104/CAZ | 7 | 68 | |
| other | Constipation | Gastrointestinal disorders | Imipenem Cilastatin | 2 | 67 | |
| other | Diarrhoea | Gastrointestinal disorders | NXL104/CAZ | 5 | 68 | |
| other | Diarrhoea | Gastrointestinal disorders | Imipenem Cilastatin | 7 | 67 | |
| other | Abdominal Distension | Gastrointestinal disorders | NXL104/CAZ | 0 | 68 | |
| other | Abdominal Distension | Gastrointestinal disorders | Imipenem Cilastatin | 5 | 67 | |
| other | Abdominal Pain | Gastrointestinal disorders | NXL104/CAZ | 5 | 68 | |
| other | Abdominal Pain | Gastrointestinal disorders | Imipenem Cilastatin | 3 | 67 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | NXL104/CAZ | 5 | 68 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Imipenem Cilastatin | 1 | 67 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NXL104/CAZ | ||
| Total, all-cause mortality | Imipenem Cilastatin | ||
| Total, other adverse events | NXL104/CAZ | 30 | 68 |
| Total, other adverse events | Imipenem Cilastatin | 33 | 67 |
| Total, serious adverse events | NXL104/CAZ | 6 | 68 |
| Total, serious adverse events | Imipenem Cilastatin | 2 | 67 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23145859 | 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 comparisons21
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NXL104/CAZ vs Imipenem Cilastatin: Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit | Trial comparisons |
| NXL104/CAZ vs Imipenem Cilastatin: Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit | Trial comparisons |
| NXL104/CAZ vs Imipenem Cilastatin: Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit | Trial comparisons |
| NXL104/CAZ vs Imipenem Cilastatin: Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit | Trial comparisons |
| NXL104/CAZ vs Imipenem Cilastatin: Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit | Trial comparisons |
| NXL104/CAZ vs Imipenem Cilastatin: Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit | Trial comparisons |
| NXL104/CAZ vs Imipenem Cilastatin: Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit | Trial comparisons |
| NXL104/CAZ vs Imipenem Cilastatin: Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit | Trial comparisons |
| NXL104/CAZ vs Imipenem Cilastatin: Clinical Outcome in CE Patients at the TOC Visit | Trial comparisons |
| NXL104/CAZ vs Imipenem Cilastatin: Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit | Trial comparisons |
1 to 10 of 21
See all 21 trial comparisonsTests0
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.
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