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

Wyeth

Status: Completed

Conditions: Stem Cell Transplantation; Myelodysplasia; Hematological Malignancy; Lymphoma; Myeloma; Leukemia

Treatments: Drug: piperacillin-tazobactam; Drug: glycopeptide

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT00195533

100943

Details and patient eligibility

About

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.

Enrollment: 801 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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