Hematological MalignancyNCT00195533
Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients
An observational study of Hematological Malignancy and Leukemia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 12 sites in Spain.
Trial summary
The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancy, Leukemia, Myelodysplasia
- What is being tested?
- piperacillin-tazobactam and glycopeptide
- How many people
- 801 participants
- Where
- 12 sitesSpain
- Study dates
- Jul 2001to Mar 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hematology units
Who may be able to join
- Patients with hematological malignancy or those who had undergone stem cell transplantation for neoplastic disease.
- Fever (>38ºC)
- Neutropenia (absolute neutrophil count < 500 or < 1000 anticipated to fall below 500 cells within 24-48 hours).
Who cannot join
- Known allergy to any of the antibiotics used in this trial
- A high probability of death within 48 hours
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Study site
A Coruña
Study site
Alcalá de Henares
Study site
Alzira
Study site
Barcelona
Study site
Castellon
Study site
Madrid
Study site
Salamanca
Study site
Santa Cruz de Tenerife
Study site
Tarragona
Study site
Valencia
Study site
Valladolid
Study site
Zaragoza
About this study
Official title: Monotherapy With Piperacillin-tazobactam Versus Combination Therapy With Piperacillin-tazobactam Plus Glycopeptide as an Initial Empiric Therapy for Fever in Neutropenic Patients. An Observational Prospective Study.
The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy.
- Conditions
- Hematological Malignancy, Leukemia, Myelodysplasia, Lymphoma, Myeloma, Stem Cell Transplantation
- Being tested
- piperacillin-tazobactam, glycopeptide
- Keywords
- Leukemia, Lymphoma, Myeloma
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Anemia, Refractory, with Excess of Blasts, Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piperacillin-tazobactamDrug
glycopeptideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Clinical efficacy evaluation:72 and 96 hours after the initiation of empirical therapy (early evaluation) and at the completion of the therapeutic trial (overall valuation)
Measured: 3 months
- Safety evaluation:during the empirical therapy
Secondary outcomes (1)
Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)
Measured: 3 Months
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 startJul 2001
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PETHEMA (Program for the Study and Treatment of Haematological Malignances)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Spain, infomed@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195533
- Sponsor's protocol ID
- 100943
- Status last verified
- Nov 2009
- First submitted
- 13 Sep 2005
- Last updated
- 16 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monotherapy With Piperacillin-tazobactam Versus Combination Therapy With Piperacillin-tazobactam Plus Glycopeptide as an Initial Empiric Therapy for Fever in Neutropenic Patients. An Observational Prospective Study.
- ClinicalTrials.gov ID
- NCT00195533
- Acronym / sponsor ID
- 100943
- Conditions
- Hematological Malignancy, Leukemia, Myelodysplasia, Lymphoma, Myeloma, Stem Cell Transplantation
- Keywords
- Leukemia, Lymphoma, Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- PETHEMA (Program for the Study and Treatment of Haematological Malignances)
- Study start
- Jul 2001
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (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 aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hematology units
Key inclusion criteria (3 listed)
- Patients with hematological malignancy or those who had undergone stem cell transplantation for neoplastic disease.
- Fever (>38ºC)
- Neutropenia (absolute neutrophil count < 500 or < 1000 anticipated to fall below 500 cells within 24-48 hours).
Key exclusion criteria (2 listed)
- Known allergy to any of the antibiotics used in this trial
- A high probability of death within 48 hours
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 | – |
| glycopeptide | Drug | – |
Primary outcome
- Clinical efficacy evaluation:72 and 96 hours after the initiation of empirical therapy (early evaluation) and at the completion of the therapeutic trial (overall valuation)
Time frame: 3 months
- Safety evaluation:during the empirical therapy
1 secondary outcome
Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)
Time frame: 3 Months
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 16 Nov 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
Trial Manager principal investigator
For Spain, infomed@wyeth.com
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Malignancy and Leukemia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 12 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 3 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 16 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
What does the primary outcome measure?
- Clinical efficacy evaluation:72 and 96 hours after the initiation of empirical therapy (early evaluation) and at the completion of the therapeutic trial (overall valuation) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 16 Nov 2009.