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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00462878
First Posted: April 19, 2007
Last Update Posted: May 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
PETHEMA Foundation
  Purpose
Observational study to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.

Condition Intervention
Allogenic Blood Stem Cell Transplantation Febrile Neutropenia Drug: Meropenem Drug: Vancomycin Drug: Teicoplanin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Estimated Enrollment: 392
Study Start Date: November 2002
Study Completion Date: April 2009
Intervention Details:
    Drug: Meropenem
    antibiotic
    Drug: Vancomycin
    Antibiotic
    Drug: Teicoplanin
    Antibiotic
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462878


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

Publications:

Responsible Party: Pethema
ClinicalTrials.gov Identifier: NCT00462878     History of Changes
Other Study ID Numbers: 03-2002-GTA
First Submitted: April 18, 2007
First Posted: April 19, 2007
Last Update Posted: May 12, 2009
Last Verified: May 2009

Keywords provided by PETHEMA Foundation:
Febrile neutropenia

Additional relevant MeSH terms:
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Vancomycin
Meropenem
Thienamycins
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents