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Observational study to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.
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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem | Drug | antibiotic | ||
| Vancomycin | Drug | Antibiotic | ||
| Teicoplanin | Drug | Antibiotic |
Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Sanz Miguel Angel, Doctor | Hospital La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Son Dureta | Palma de Mallorca | Balearic Islands | Spain | |||
| Hospital U. Germans Trias i Pujol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8957718 | Background | 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. | |
| 10605194 | Background | 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. |
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| 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 |
| 9702394 | Background | 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. |
| 11850858 | Background | 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. |
| 9613785 | Background | 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. |
| 10918433 | Background | 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. |
| 10021469 | Background | 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. |
| 8869095 | Background | 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. |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| D014640 | Vancomycin |
| D017334 | Teicoplanin |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077427 | Lipoglycopeptides |
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