Gram-Positive Bacterial InfectionsNCT00167999
Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units
An observational study of Gram-Positive Bacterial Infections and Escherichia Coli Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in South Korea.
Trial summary
To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Gram-Positive Bacterial Infections, Escherichia Coli Infections, Klebsiella Infections
- What is being tested?
- piperacillin-tazobactam
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2005to not given
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible patients of either sex, 15 years of age or older
- Patients who are admitted to the department of hematology and oncology
- Provide written informed consent
Who cannot join
- Patients who have hypersensitivity to β-lactam antibiotics
- Female who are pregnant or breast-feeding
- Any underlying conditions or non-infectious diseases that will be ultimately fatal within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Piperacillin-Tazobactam Use on the Prevalence Rate of Extended-Spectrum Beta-Lactamase (ESBL) Producing Escherichia Coli and Klebsiella Pneumoniae in Hematology and Oncology Units.
To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units
- Being tested
- piperacillin-tazobactam
- Keywords
- Bacterial Infections
- Medical subject headings
- Gram-Positive Bacterial Infections, Escherichia coli Infections, Klebsiella Infections, Bacterial 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 posted14 Sep 2005 (estimated)
- Study startFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Positive Bacterial 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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants
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
- NCT00167999
- Sponsor's protocol ID
- 0910X-101676
- Status last verified
- Mar 2007
- First submitted
- 11 Sep 2005
- Last updated
- 15 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Piperacillin-Tazobactam Use on the Prevalence Rate of Extended-Spectrum Beta-Lactamase (ESBL) Producing Escherichia Coli and Klebsiella Pneumoniae in Hematology and Oncology Units.
- ClinicalTrials.gov ID
- NCT00167999
- Acronym / sponsor ID
- 0910X-101676
- Keywords
- Bacterial Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- First posted
- 14 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.
To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible patients of either sex, 15 years of age or older
- Patients who are admitted to the department of hematology and oncology
- Provide written informed consent
Key exclusion criteria (3 listed)
- Patients who have hypersensitivity to β-lactam antibiotics
- Female who are pregnant or breast-feeding
- Any underlying conditions or non-infectious diseases that will be ultimately fatal within 30 days
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 15 Mar 2007.
Related trials for Gram-Positive Bacterial Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gram-Positive Bacterial Infections and Escherichia Coli Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in South Korea.
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 3 inclusion and 3 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 15 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 15 Mar 2007.