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

Lymphoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195533
• Other study ID #: 100943
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 13, 2009
• Start date: July 2001
• Est. completion date: March 2005

Study information

• Verified date: November 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hematological Malignancy
• Leukemia
• Lymphoma
• Myelodysplasia
• Myelodysplastic Syndromes
• Myeloma
• Preleukemia
• Stem Cell Transplantation

Intervention

Drug:
• piperacillin-tazobactam

• glycopeptide

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer	PETHEMA (Program for the Study and Treatment of Haematological Malignances)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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)		3 months	No
Primary	- Safety evaluation:during the empirical therapy
Secondary	Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)		3 Months	No