Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation (MERONEM)

PETHEMA Foundation

Status: Completed

Conditions: Febrile Neutropenia; Allogenic Blood Stem Cell Transplantation

Treatments: Drug: Teicoplanin; Drug: Meropenem; Drug: Vancomycin

Study type: Observational

Funder types: Other

Identifiers

NCT00462878

03-2002-GTA

Details and patient eligibility

About

Observational study to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.

Full description

Observational study cost-effectivity to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.

The study will be done in two consecutive cohorts of patients. First cohort: meropenem 1g/8h ev Second cohort: meropenem 1g/8h and glycopeptide (vancomycin 1g/12 h or teicoplanin 400 mg/24h)

Enrollment: 392 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Patients submitted to allogenic transplant
• Neutropenia: neutrophils account < 500/mm3 or neutrophils account < 1000/mm3 with prevision to decrease until 500/mm3 at the next 24-48 h
• Signs and symptoms to infection
• Fever: Temperature> 38,3 ºC registered one time, or 38 ºC en two times separated 60 minutes in a period of 12 h.

Exclusion criteria

• Medical history of meropenem or glycopeptides hypersensitivity
• Renal failure or creatinine in serum > 2,25 mg/dl or creatinine clearance < 40 ml
• Liver insufficiency
• Childbearing potential or breast feeding period
• Contraindications to meropenem, vancomycin or teicoplanin