Clinical trial NCT00462878: Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allogenic Blood Stem Cell Transplantation
Febrile Neutropenia
Keywords: Febrile neutropenia
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2007-04-19
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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)

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

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
state: Balears
city: Badalona
country: Spain
facility: Hospital U. Germans Trias i Pujol
state: Barcelona
city: Manresa
country: Spain
facility: Hospital General de Manresa
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Niño Jesus
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua Tarrasa
state: Barcelona
city: Las palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Las Palmas
state: Canarias
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Materno-Infantil de Las Palmas
state: Canarias
city: las Palmas de Gran Canaria
country: Spain
facility: Hospital Ntra Sra del Pino/Sabinal
state: Canarias
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Canarias
city: Leon
country: Spain
facility: Hospital Virgen Blanca
state: León
city: Alcalá de Henares
country: Spain
facility: Hospital Principe de Asturias
state: Madrid
city: Leganes
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
state: Tarragona
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Xativa
country: Spain
facility: Hospital Luis Alcañiz de Xátiva
state: Valencia
city: Alicante
country: Spain
facility: Hospital G. de Alicante
city: Alzira
country: Spain
facility: Hospital de la Ribera
city: Barcelona
country: Spain
facility: Hospital C. de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Durant y Reynals
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital U. Vall D'Hebron
city: Basurto
country: Spain
facility: Basurtuko Ospitalea
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Castellón
country: Spain
facility: Hospital General de Castellón
city: Cáceres
country: Spain
facility: Hospital San Millan
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Gandia
country: Spain
facility: Hospital Francesc de Borja
city: Girona
country: Spain
facility: Hospital Doctor Josep Trueta
city: Granada
country: Spain
facility: Hospital Virgen de Las Nieves
city: La Coruña
country: Spain
facility: H. Xeral de Galicia
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Lugo
country: Spain
facility: Complexo H. Xeral-Calde
city: Madrid
country: Spain
facility: Clínica Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital General de Murcia
city: Murcia
country: Spain
facility: Hospital Reina Sofia
city: Murcia
country: Spain
facility: Hospital U. Virgen de la Arrixaca
city: Málaga
country: Spain
facility: H. Universitario Virgen de la Victoria
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Salamanca
country: Spain
facility: Hospital Universitario Salamanca
city: Santander
country: Spain
facility: Hospital Aránzazu
city: Santander
country: Spain
facility: Hospital U. Marques de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Vírgen del Rocío
city: Tarragona
country: Spain
facility: Hospital de Tarragona "Joan XXIII"
city: Valencia
country: Spain
facility: Hospital Arnao de Vilanova
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Dr. Peset
city: Valencia
country: Spain
facility: Hospital General U. de Valencia
city: Valencia
country: Spain
facility: Hospital U. La Fe (H. Infantil)
city: Valencia
country: Spain
facility: Hospital U. La Fe
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valladolid
country: Spain
facility: Hospital C. de Valladolid
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
city: Vigo
country: Spain
facility: Hospital do Meixoeiro
city: Zaragoza
country: Spain
facility: Hospital C.U. De Zaragoza
city: Zaragoza
country: Spain
facility: Miguel Servet
Study officials:
affiliation: Hospital La Fe
name: Sanz Miguel Angel, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Spanish.
citation: 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.
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. doi: 10.1086/339215. Epub 2002 Feb 13. No abstract available.
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. doi: 10.1038/sj.bmt.1701201.
citation: 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.
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. doi: 10.1056/NEJM199902183400701.
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. doi: 10.1016/0959-8049(96)00050-0.