Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections.
NCT00195286
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Adult Trials: 18+ Years
- Hospitalized patients over 16 years of age with complicated urinary infection produced by bacteria that are suspected to be susceptible to treatment with Piperacillin-tazobactam.
- Patients known, or thought to be hypersensitivity to beta-lactams
- Patients with an uncomplicated urinary tract infection
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections. | |||
| Official Title | Study of the Safety and Efficacy of Piperacillin/Tazobactam in the Treatment of Patients With Complicated Urinary Infections. | |||
| Brief Summary | The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients treated at internal medicine units | |||
| Condition | Urinary Infections | |||
| Intervention | Drug: piperacillin/tazobactam | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 180 | |||
| Original Enrollment | 300 | |||
| Actual Study Completion Date | July 2007 | |||
| Actual Primary Completion Date | July 2007 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 16 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Spain | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00195286 | |||
| Other Study ID Numbers | 101315 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | September 2009 | |||