You are here

Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Alcalá de Henares, , Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hematological Malignancy, Leukemia, Myelodysplasia, Lymphoma, Myeloma, Stem Cell Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with hematological malignancy or those who had undergone stem cell
transplantation for neoplastic disease.

- Fever (>38ºC)

- Neutropenia (absolute neutrophil count cells within 24-48 hours).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Known allergy to any of the antibiotics used in this trial

- A high probability of death within 48 hours

NCT00195533
Pfizer
Completed
Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL), Castration Resistant Prostate Cancer (CRPC), Diffuse Large B-Cell Lymphoma (DLBCL)
NCT03460977
All Genders
18+
Years
Multiple Sites
Leukemia, Precursor b-Cell Lymphoblastic Leukemia-Lymphoma, ACUTE LYMPHOBLASTIC LEUKEMIA
NCT03677596
All Genders
18+
Years
Multiple Sites
Acute Myeloid Leukemia
NCT02038777
All Genders
20+
Years
Multiple Sites
Descriptive Information
Brief TitleStudy Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients
Official TitleMonotherapy 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.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
Whole blood
Sampling MethodNon-Probability Sample
Study PopulationHematology units
Condition
  • Hematological Malignancy
  • Leukemia
  • Myelodysplasia
  • Lymphoma
  • Myeloma
  • Stem Cell Transplantation
Intervention
  • Drug: piperacillin-tazobactam
  • Drug: glycopeptide
Study Groups/CohortsNot 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 StatusCompleted
Actual Enrollment
 (submitted: November 13, 2009)
801
Original Enrollment
 (submitted: September 15, 2005)
752
Actual Study Completion DateMarch 2005
Actual Primary Completion DateMarch 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Known allergy to any of the antibiotics used in this trial
  • A high probability of death within 48 hours
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesSpain
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00195533
Other Study ID Numbers100943
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsPETHEMA (Program for the Study and Treatment of Haematological Malignances)
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Spain, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateNovember 2009

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now