Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation - Full Text View

Sponsor:	PETHEMA Foundation
Information provided by:	PETHEMA Foundation
ClinicalTrials.gov Identifier:	NCT00462878

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:	Case-Only, 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:

MedlinePlus related topics: Fever

Drug Information available for: Teicoplanin Meropenem Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by PETHEMA Foundation:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	392
Study Start Date:	November 2002
Study Completion Date:	April 2009

Intervention Details:

antibiotic

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462878

Show 64 Study Locations

Sponsors and Collaborators

PETHEMA Foundation

Investigators

Principal Investigator:

Sanz Miguel Angel, Doctor

Hospital La Fe

More Information

Publications:

Cometta A, Glauser MP. Empiric antibiotic monotherapy with carbapenems in febrile neutropenia: a review. J Chemother. 1996 Oct;8(5):375-81. Review.

Klastersky J. Current attitudes for therapy of febrile neutropenia with consideration to cost-effectiveness. Curr Opin Oncol. 1998 Jul;10(4):284-90.

Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. Epub 2002 Feb 13. No abstract available.

Koya R, Andersen J, Fernandez H, Goodman M, Spector N, Smith R, Hanlon J, Cassileth PA. Analysis of the value of empiric vancomycin administration in febrile neutropenia occurring after autologous peripheral blood stem cell transplants. Bone Marrow Transplant. 1998 May;21(9):923-6.

Celebi H, Akan H, Akcaglayan E, Ustun C, Arat M. Febrile neutropenia in allogeneic and autologous peripheral blood stem cell transplantation and conventional chemotherapy for malignancies. Bone Marrow Transplant. 2000 Jul;26(2):211-4.

Smith TL, Pearson ML, Wilcox KR, Cruz C, Lancaster MV, Robinson-Dunn B, Tenover FC, Zervos MJ, Band JD, White E, Jarvis WR. Emergence of vancomycin resistance in Staphylococcus aureus. Glycopeptide-Intermediate Staphylococcus aureus Working Group. N Engl J Med. 1999 Feb 18;340(7):493-501.

Dompeling EC, Donnelly JP, Deresinski SC, Feld R, Lane-Allman EF, De Pauw BE. Early identification of neutropenic patients at risk of grampositive bacteraemia and the impact of empirical administration of vancomycin. Eur J Cancer. 1996 Jul;32A(8):1332-9.

Responsible Party:	Pethema ( Pethema )
Study ID Numbers:	03-2002-GTA
Study First Received:	April 18, 2007
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00462878 History of Changes
Health Authority:	Spain: Spanish Ministry of Health

Keywords provided by PETHEMA Foundation:

Febrile neutropenia

Additional relevant MeSH terms:

Anti-Infective Agents
Teicoplanin
Hematologic Diseases
Agranulocytosis
Leukocyte Disorders
Body Temperature Changes
Pharmacologic Actions
Fever

Neutropenia
Signs and Symptoms
Anti-Bacterial Agents
Therapeutic Uses
Meropenem
Vancomycin
Leukopenia

ClinicalTrials.gov processed this record on November 20, 2009