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

MERONEM: Observational Study About Efficacy of Meropenem in Comparison of Meropenem and Glycopeptide in Treatment of Neutropenia Febrile in Allogenic Blood Stem Cell Transplantation Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00462878
Acronym
MERONEM
Enrollment
392
Registered
2007-04-19
Start date
2002-11-30
Completion date
2009-04-30
Last updated
2009-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogenic Blood Stem Cell Transplantation, Febrile Neutropenia

Keywords

Febrile neutropenia

Brief summary

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

Detailed 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)

Interventions

DRUGMeropenem

antibiotic

DRUGVancomycin

Antibiotic

DRUGTeicoplanin

Antibiotic

Sponsors

PETHEMA Foundation
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026