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

Information source: PETHEMA Foundation
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allogenic Blood Stem Cell Transplantation; Febrile Neutropenia

Intervention: Meropenem (Drug); Vancomycin (Drug); Teicoplanin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: PETHEMA Foundation

Official(s) and/or principal investigator(s):
Sanz Miguel Angel, Doctor, Principal Investigator, Affiliation: Hospital La Fe

Overall contact:
Sanz Miguel Angel, Dr, Phone: 34. 96 197 30 57, Email: sanz_mig@gva.es

Summary

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

Clinical Details

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

Study design: Case-Only, Prospective

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Sanz Miguel Angel, Dr, Phone: 34. 96 197 30 57, Email: sanz_mig@gva.es

Hospital de la Ribera, Alzira, Spain; Recruiting

Hospital Francesc de Borja, Gandia, Spain; Recruiting

Hospital San Millan, Cáceres, Spain; Recruiting

Hospital Virgen de Las Nieves, Granada, Spain; Recruiting

Hospital Rio Hortega, Valladolid, Spain; Recruiting

Basurtuko Ospitalea, Basurto, Spain; Recruiting

Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain; Recruiting

Hospital de Cruces, Bilbao, Spain; Recruiting

Hospital G. de Alicante, Alicante, Spain; Recruiting

Hospital Clínico Universitario de Valencia, Valencia, Spain; Recruiting

Hospital Universitario Salamanca, Salamanca, Spain; Recruiting

Complexo H. Xeral-Calde, Lugo, Spain; Recruiting

Hospital Clínico San Carlos, Madrid, Spain; Recruiting

Hospital U. La Fe (H. Infantil), Valencia, Spain; Recruiting

Hospital C. de Barcelona, Barcelona, Spain; Recruiting

Hospital Sant Pau, Barcelona, Spain; Recruiting

Hospital U. Vall D'Hebron, Barcelona, Spain; Recruiting

Hospital Durant y Reynals, Barcelona, Spain; Recruiting

Hospital del Mar, Barcelona, Spain; Recruiting

Hospital General de Castellón, Castellón, Spain; Recruiting

Hospital Puerta del Mar, Cádiz, Spain; Recruiting

Hospital Doctor Josep Trueta, Girona, Spain; Recruiting

H. Xeral de Galicia, La Coruña, Spain; Recruiting

Hospital Juan Canalejo, La Coruña, Spain; Recruiting

Hospital La Princesa, Madrid, Spain; Recruiting

Hospital Gregorio Marañón, Madrid, Spain; Recruiting

Hospital Ramón y Cajal, Madrid, Spain; Recruiting

Clínica Puerta de Hierro, Madrid, Spain; Recruiting

Hospital La Paz, Madrid, Spain; Recruiting

Hospital 12 de Octubre, Madrid, Spain; Recruiting

Hospital U. Virgen de la Arrixaca, Murcia, Spain; Recruiting

Hospital General de Murcia, Murcia, Spain; Recruiting

Hospital Reina Sofia, Murcia, Spain; Recruiting

Hospital Carlos Haya, Málaga, Spain; Recruiting

H. Universitario Virgen de la Victoria, Málaga, Spain; Recruiting

Hospital Aránzazu, Santander, Spain; Recruiting

Hospital U. Marques de Valdecilla, Santander, Spain; Recruiting

Hospital Vírgen del Rocío, Sevilla, Spain; Recruiting

Hospital de Tarragona "Joan XXIII", Tarragona, Spain; Recruiting

Hospital U. La Fe, Valencia, Spain; Recruiting

Hospital General U. de Valencia, Valencia, Spain; Recruiting

Hospital Arnao de Vilanova, Valencia, Spain; Recruiting

Instituto Valenciano de Oncología, Valencia, Spain; Recruiting

Hospital Dr. Peset, Valencia, Spain; Recruiting

Hospital C. de Valladolid, Valladolid, Spain; Recruiting

Hospital do Meixoeiro, Vigo, Spain; Recruiting

Hospital C.U. De Zaragoza, Zaragoza, Spain; Recruiting

Miguel Servet, Zaragoza, Spain; Recruiting

Hospital Central de Asturias, Oviedo, Asturias, Spain; Recruiting

Hospital Son Dureta, Palma de Mallorca, Balears, Spain; Recruiting

Hospital U. Germans Trias i Pujol, Badalona, Barcelona, Spain; Recruiting

Hospital General de Manresa, Manresa, Barcelona, Spain; Recruiting

Hospital Niño Jesus, Sabadell, Barcelona, Spain; Recruiting

Hospital Mutua Tarrasa, Terrassa, Barcelona, Spain; Recruiting

Hospital Universitario de Canarias, Tenerife, Canarias, Spain; Recruiting

Hospital Materno-Infantil de Las Palmas, Las Palmas de Gran Canaria, Canarias, Spain; Recruiting

Hospital Ntra Sra del Pino/Sabinal, las Palmas de Gran Canaria, Canarias, Spain; Recruiting

Hospital Insular de Las Palmas, Las palmas de Gran Canaria, Canarias, Spain; Recruiting

Hospital Virgen Blanca, Leon, León, Spain; Recruiting

Hospital Principe de Asturias, Alcalá de Henares, Madrid, Spain; Recruiting

Hospital Severo Ochoa, Leganes, Madrid, Spain; Recruiting

Hospital Verge de la Cinta, Tortosa, Tarragona, Spain; Recruiting

Hospital Luis Alcañiz de Xátiva, Xativa, Valencia, Spain; Recruiting

Hospital de Sagunto, Sagunto, Valencia, Spain; Recruiting

Additional Information

Related 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.

Starting date: November 2002
Ending date: April 2007
Last updated: November 26, 2008

Page last updated: February 12, 2009

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