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Trial record 1 of 1 for:    NCT00195533
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Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients

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ClinicalTrials.gov Identifier: NCT00195533
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 16, 2009
Sponsor:
Collaborator:
PETHEMA (Program for the Study and Treatment of Haematological Malignances)
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 19, 2005
Last Update Posted Date November 16, 2009
Study Start Date July 2001
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2009)
  • - 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
Original Primary Outcome Measures
 (submitted: September 15, 2005)
  • - 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)
  • - Safety evaluation:during the empirical therapy
Change History
Current Secondary Outcome Measures
 (submitted: November 13, 2009)
Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation) [ Time Frame: 3 Months ]
Original Secondary Outcome Measures
 (submitted: September 15, 2005)
Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients
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.
Brief 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). 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 Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood
Sampling Method Non-Probability Sample
Study Population Hematology units
Condition
  • Hematological Malignancy
  • Leukemia
  • Myelodysplasia
  • Lymphoma
  • Myeloma
  • Stem Cell Transplantation
Intervention
  • Drug: piperacillin-tazobactam
  • Drug: glycopeptide
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
 (submitted: November 13, 2009)
801
Original Enrollment
 (submitted: September 15, 2005)
752
Actual Study Completion Date March 2005
Actual Primary Completion Date March 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
Ages 18 Years and older   (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 NCT00195533
Other Study ID Numbers 100943
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators PETHEMA (Program for the Study and Treatment of Haematological Malignances)
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date November 2009