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

May 11, 2009 updated by: PETHEMA Foundation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Anticipated)

392

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital G. de Alicante
      • Alzira, Spain
        • Hospital de la Ribera
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital U. Vall D'Hebron
      • Barcelona, Spain
        • Hospital Sant Pau
      • Barcelona, Spain
        • Hospital C. de Barcelona
      • Barcelona, Spain
        • Hospital Durant y Reynals
      • Basurto, Spain
        • Basurtuko Ospitalea
      • Bilbao, Spain
        • Hospital de Cruces
      • Castellón, Spain
        • Hospital General de Castellon
      • Cáceres, Spain
        • Hospital San Millan
      • Cádiz, Spain
        • Hospital Puerta del Mar
      • Gandia, Spain
        • Hospital Francesc de Borja
      • Girona, Spain
        • Hospital Doctor Josep Trueta
      • Granada, Spain
        • Hospital Virgen de las Nieves
      • La Coruña, Spain
        • Hospital Juan Canalejo
      • La Coruña, Spain
        • H. Xeral de Galicia
      • Lugo, Spain
        • Complexo H. Xeral-Calde
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital 12 de octubre
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital La Princesa
      • Madrid, Spain
        • Clínica Puerta de Hierro
      • Murcia, Spain
        • Hospital Reina Sofía
      • Murcia, Spain
        • Hospital General de Murcia
      • Murcia, Spain
        • Hospital U. Virgen de la Arrixaca
      • Málaga, Spain
        • Hospital Carlos Haya
      • Málaga, Spain
        • H. Universitario Virgen de la Victoria
      • Salamanca, Spain
        • Hospital Universitario Salamanca
      • Santander, Spain
        • Hospital Aránzazu
      • Santander, Spain
        • Hospital U. Marques de Valdecilla
      • Santiago de Compostela, Spain
        • Hospital Clinico Universitario de Santiago
      • Sevilla, Spain
        • Hospital Virgen del Rocío
      • Tarragona, Spain
        • Hospital de Tarragona "Joan XXIII"
      • Valencia, Spain
        • Instituto Valenciano de Oncología
      • Valencia, Spain
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • Hospital Dr. Peset
      • Valencia, Spain
        • Hospital Arnao de Vilanova
      • Valencia, Spain
        • Hospital General U. de Valencia
      • Valencia, Spain
        • Hospital U. La Fe (H. Infantil)
      • Valencia, Spain
        • Hospital U. La Fe
      • Valladolid, Spain
        • Hospital Rio Hortega
      • Valladolid, Spain
        • Hospital C. de Valladolid
      • Vigo, Spain
        • Hospital Do Meixoeiro
      • Zaragoza, Spain
        • Miguel Servet
      • Zaragoza, Spain
        • Hospital C.U. De Zaragoza
    • Asturias
      • Oviedo, Asturias, Spain
        • Hospital Central de Asturias
    • Balears
      • Palma de Mallorca, Balears, Spain
        • Hospital Son Dureta
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital U. Germans Trias i Pujol
      • Manresa, Barcelona, Spain
        • Hospital General de Manresa
      • Sabadell, Barcelona, Spain
        • Hospital Niño Jesús
      • Terrassa, Barcelona, Spain
        • Hospital Mutua Tarrasa
    • Canarias
      • Las Palmas de Gran Canaria, Canarias, Spain
        • Hospital Materno-Infantil de Las Palmas
      • Las palmas de Gran Canaria, Canarias, Spain
        • Hospital Insular de las Palmas
      • Tenerife, Canarias, Spain
        • Hospital Universitario de Canarias
      • las Palmas de Gran Canaria, Canarias, Spain
        • Hospital Ntra Sra del Pino/Sabinal
    • León
      • Leon, León, Spain
        • Hospital Virgen Blanca
    • Madrid
      • Alcalá de Henares, Madrid, Spain
        • Hospital Principe de Asturias
      • Leganes, Madrid, Spain
        • Hospital Severo Ochoa
    • Tarragona
      • Tortosa, Tarragona, Spain
        • Hospital Verge de la Cinta
    • Valencia
      • Sagunto, Valencia, Spain
        • Hospital de Sagunto
      • Xativa, Valencia, Spain
        • Hospital Luis Alcañiz de Xátiva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients submitted to allogenic transplant with 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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Principal Investigator: Sanz Miguel Angel, Doctor, Hospital la Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

April 18, 2007

First Posted (Estimate)

April 19, 2007

Study Record Updates

Last Update Posted (Estimate)

May 12, 2009

Last Update Submitted That Met QC Criteria

May 11, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-2002-GTA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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