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Completed

NCT Number: NCT00195533

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

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.

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Key information

Conditions

Hematological Malignancy Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplasia Myelodysplastic Syndromes Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Stem Cell Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piperacillin-tazobactam

Drug

glycopeptide

Drug

Primary outcomes

  1. - 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

  2. - Safety evaluation:during the empirical therapy

Secondary outcomes

  1. Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)

    Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Collaborators

  • PETHEMA (Program for the Study and Treatment of Haematological Malignances)

Registry information

Official study 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.

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Nov 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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