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

NCT00195533

Last updated date
Study Location
Alcalá de Henares, , , Spain
Contact
1-800-718-1021

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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 < 500 or < 1000 anticipated to fall below 500 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

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Hematological Malignancy, Leukemia, Myelodysplasia, Lymphoma, Myeloma, Stem Cell TransplantationStudy Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients
NCT00195533
  1. Alcalá de Henares,
  2. Alcira,
  3. Barcelona,
  4. Castellon,
  5. Coruña,
  6. Madrid,
  7. Salamanca,
  8. Tarragona,
  9. Tenerife,
  10. Valencia,
  11. Valladolid,
  12. Zaragoza,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Spain, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date November 2009