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

Febrile Neutropenia Clinical Trial

— MERONEM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462878
• Other study ID #: 03-2002-GTA
• Status: Completed
• Phase: N/A
• First received: April 18, 2007
• Last updated: May 11, 2009
• Start date: November 2002
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allogenic Blood Stem Cell Transplantation
• Febrile Neutropenia
• Fever
• Neutropenia

Intervention

Drug:
• Meropenem
antibiotic
• Vancomycin
Antibiotic
• Teicoplanin
Antibiotic

Locations

Country	Name	City	State
Spain	Hospital Principe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital G. de Alicante	Alicante
Spain	Hospital de la Ribera	Alzira
Spain	Hospital U. Germans Trias i Pujol	Badalona	Barcelona
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 San Millan	Cáceres
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital General de Castellón	Castellón
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	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 Severo Ochoa	Leganes	Madrid
Spain	Hospital Virgen Blanca	Leon	León
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	H. Universitario Virgen de la Victoria	Málaga
Spain	Hospital Carlos Haya	Málaga
Spain	Hospital General de Manresa	Manresa	Barcelona
Spain	Hospital General de Murcia	Murcia
Spain	Hospital Reina Sofia	Murcia
Spain	Hospital U. Virgen de la Arrixaca	Murcia
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital Son Dureta	Palma de Mallorca	Balears
Spain	Hospital Niño Jesus	Sabadell	Barcelona
Spain	Hospital de Sagunto	Sagunto	Valencia
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 Universitario de Canarias	Tenerife	Canarias
Spain	Hospital Mutua Tarrasa	Terrassa	Barcelona
Spain	Hospital Verge de la Cinta	Tortosa	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	Valencia
Spain	Hospital U. La Fe (H. Infantil)	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 Luis Alcañiz de Xátiva	Xativa	Valencia
Spain	Hospital C.U. De Zaragoza	Zaragoza
Spain	Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Celebi H, Akan H, Akçaglayan E, Ustün 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. — View Citation

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

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. — View Citation

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. — View Citation

Jarque I, Sanz MA. [Application of the concepts of evidence-based medicine to the evidence on the treatment of febrile neutropenia]. Enferm Infecc Microbiol Clin. 1999;17 Suppl 2:95-102. Review. Spanish. — View Citation

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

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. — View Citation

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. — View Citation