Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation
NCT ID: NCT00462878
Last Updated: 2009-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
392 participants
OBSERVATIONAL
2002-11-30
2009-04-30
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Meropenem
antibiotic
Vancomycin
Antibiotic
Teicoplanin
Antibiotic
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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Pethema
Principal Investigators
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Sanz Miguel Angel, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital La Fe
Locations
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Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain
Hospital U. Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital C. de Barcelona
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Durant y Reynals
Barcelona, Barcelona, Spain
Hospital Sant Pau
Barcelona, Barcelona, Spain
Hospital U. Vall D'Hebron
Barcelona, 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, Canary Islands, Spain
Hospital Materno-Infantil de Las Palmas
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Ntra Sra del Pino/Sabinal
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Aránzazu
Santander, Cantabria, Spain
Hospital U. Marques de Valdecilla
Santander, Cantabria, Spain
Hospital General de Castellón
Castellon, Castellón, Spain
Hospital Puerta del Mar
Cadiz, Cádiz, Spain
Hospital Doctor Josep Trueta
Girona, Girona, Spain
H. Xeral de Galicia
A Coruña, La Coruña, Spain
Hospital Juan Canalejo
A Coruña, La Coruña, Spain
Hospital Virgen Blanca
León, León, Spain
Hospital Principe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
Clínica Puerta de Hierro
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Gregorio Marañón
Madrid, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital La Princesa
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital General de Murcia
Murcia, Murcia, Spain
Hospital Reina Sofia
Murcia, Murcia, Spain
Hospital U. Virgen de la Arrixaca
Murcia, Murcia, Spain
H. Universitario Virgen de la Victoria
Málaga, Málaga, Spain
Hospital Carlos Haya
Málaga, Málaga, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Vírgen del Rocío
Seville, Sevilla, Spain
Hospital de Tarragona "Joan XXIII"
Tarragona, Tarragona, Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Arnao de Vilanova
Valencia, Valencia, Spain
Hospital Dr. Peset
Valencia, Valencia, Spain
Hospital General U. de Valencia
Valencia, Valencia, Spain
Hospital U. La Fe
Valencia, Valencia, Spain
Instituto Valenciano de Oncología
Valencia, Valencia, Spain
Hospital Luis Alcañiz de Xátiva
Xàtiva, Valencia, Spain
Hospital C. de Valladolid
Valladolid, Valladolid, Spain
Hospital do Meixoeiro
Vigo, Vigo, Spain
Hospital C.U. De Zaragoza
Zaragoza, Zaragoza, Spain
Miguel Servet
Zaragoza, Zaragoza, Spain
Hospital G. de Alicante
Alicante, , Spain
Hospital de la Ribera
Alzira, , Spain
Basurtuko Ospitalea
Basurto, , Spain
Hospital de Cruces
Bilbao, , Spain
Hospital San Millan
Cáceres, , Spain
Hospital Francesc de Borja
Gandia, , Spain
Hospital Virgen de Las Nieves
Granada, , Spain
Complexo H. Xeral-Calde
Lugo, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario Salamanca
Salamanca, , Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital U. La Fe (H. Infantil)
Valencia, , Spain
Hospital Rio Hortega
Valladolid, , Spain
Countries
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References
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Cometta A, Glauser MP. Empiric antibiotic monotherapy with carbapenems in febrile neutropenia: a review. J Chemother. 1996 Oct;8(5):375-81. doi: 10.1179/joc.1996.8.5.375.
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. Spanish.
Klastersky J. Current attitudes for therapy of febrile neutropenia with consideration to cost-effectiveness. Curr Opin Oncol. 1998 Jul;10(4):284-90. doi: 10.1097/00001622-199807000-00002.
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. doi: 10.1086/339215. 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. doi: 10.1038/sj.bmt.1701201.
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. doi: 10.1038/sj.bmt.1702503.
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. doi: 10.1056/NEJM199902183400701.
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. doi: 10.1016/0959-8049(96)00050-0.
Other Identifiers
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03-2002-GTA
Identifier Type: -
Identifier Source: org_study_id
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