Urinary InfectionsNCT00195286
Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections.
An observational study of Urinary Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 27 sites in Spain.
Trial summary
The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Urinary Infections
- What is being tested?
- piperacillin/tazobactam
- How many people
- 180 participants
- Where
- 27 sitesSpain
- Study dates
- Jun 2004to Jul 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated at internal medicine units
Who may be able to join
- 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.
Who cannot join
- Patients known, or thought to be hypersensitivity to beta-lactams
- Patients with an uncomplicated urinary tract infection
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Spain27 sites
Study site
Antequera (Málaga)
Study site
Ávila
Study site
Barcelona
Study site
Berga (Barcelona)
Study site
Cáceres
Study site
Cadiz
Study site
Castellon
Study site
Ciudad Real
Study site
Cuenca
Study site
Ferrol
Study site
Granada
Study site
Jaén
Study site
Las Palmas
Study site
Lleida
Study site
Lorca (Murcia)
Study site
Lugo
Study site
Madrid
Study site
Osuna (Sevilla)
Study site
Palma Mallorca
Study site
Pamplona
Study site
Pontevedra
Study site
Terrassa
Study site
Torrelavega
Study site
Valencia
Study site
Valladolid
Study site
Vitoria-Gasteiz
Study site
Zaragoza
About this study
Official title: Study of the Safety and Efficacy of Piperacillin/Tazobactam in the Treatment of Patients With Complicated Urinary Infections.
The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections
- Conditions
- Urinary Infections
- Being tested
- piperacillin/tazobactam
- Keywords
- Urinary Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piperacillin/tazobactamDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195286
- Sponsor's protocol ID
- 101315
- Status last verified
- Sep 2009
- First submitted
- 12 Sep 2005
- Last updated
- 25 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of Piperacillin/Tazobactam in the Treatment of Patients With Complicated Urinary Infections.
- ClinicalTrials.gov ID
- NCT00195286
- Acronym / sponsor ID
- 101315
- Conditions
- Urinary Infections
- Keywords
- Urinary Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated at internal medicine units
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients known, or thought to be hypersensitivity to beta-lactams
- Patients with an uncomplicated urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| piperacillin/tazobactam | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 27 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2009.