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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborator: PETHEMA (Program for the Study and Treatment of Haematological Malignances)
• Treatments: Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

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