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

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

Sponsors

Lead sponsor: PETHEMA Foundation

Source PETHEMA Foundation
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)

Overall Status Completed
Start Date November 2002
Completion Date April 2009
Study Type Observational
Enrollment 392
Condition
Intervention

Intervention type: Drug

Intervention name: Meropenem

Description: antibiotic

Intervention type: Drug

Intervention name: Vancomycin

Description: Antibiotic

Intervention type: Drug

Intervention name: Teicoplanin

Description: Antibiotic

Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sanz Miguel Angel, Doctor Principal Investigator Hospital La Fe
Location
facility
Hospital Central de Asturias | Oviedo, Asturias, Spain
Hospital Son Dureta | Palma de Mallorca, Balears, Spain
Hospital U. Germans Trias i Pujol | Badalona, 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, 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 Universitario de Canarias | Tenerife, Canarias, Spain
Hospital Virgen Blanca | Leon, León, Spain
Hospital Principe de Asturias | Alcalá de Henares, Madrid, Spain
Hospital Severo Ochoa | Leganes, Madrid, Spain
Hospital Verge de la Cinta | Tortosa, Tarragona, Spain
Hospital de Sagunto | Sagunto, Valencia, Spain
Hospital Luis Alcañiz de Xátiva | Xativa, Valencia, Spain
Hospital G. de Alicante | Alicante, Spain
Hospital de la Ribera | Alzira, 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 General de Castellón | Castellón, Spain
Hospital San Millan | Cáceres, Spain
Hospital Puerta del Mar | Cádiz, 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
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
Hospital General de Murcia | Murcia, Spain
Hospital Reina Sofia | Murcia, Spain
Hospital U. Virgen de la Arrixaca | Murcia, Spain
H. Universitario Virgen de la Victoria | Málaga, Spain
Hospital Carlos Haya | Málaga, 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 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 (H. Infantil) | Valencia, Spain
Hospital U. La Fe | 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 C.U. De Zaragoza | Zaragoza, Spain
Miguel Servet | Zaragoza, Spain
Location Countries

Spain

Verification Date

May 2009

Responsible Party

Name title: Pethema

Organization: Pethema

Keywords
Has Expanded Access No
Condition Browse
Acronym MERONEM
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov