Phase
Condition
Soft Tissue Infections
Sepsis And Septicemia
Treatment
Meropenem
Temocillin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult patients with monomicrobial bacteremia due to Enterobacteriaceae showingresistance to cefotaxime, ceftriaxone (MIC >2 mg/L) and/or ceftazidime (MIC >4mg/L), and sensible to temocillin (MIC ≤8 mg/L, except in bacteremia only of urinaryorigin, for which the criterion is MIC ≤16 mg/L ) and meropenem (MIC ≤2 mg/L).
Patients with polymicrobial bacteremia caused by more than one Enterobacteriaceae species may also be included, provided at least one of them is resistant to third-generation cephalosporins, and both are susceptible to meropenem and temocillin.
Duration of intravenous treatment is planned to be at least 4 days fromrandomization, or 3 days if the empirical treatment prior to randomization wasactive.
The patient signed informed consent form.
Potentially fertile patients must have a negative pregnancy test.
Exclusion
Exclusion Criteria:
<18 years
Pregnancy
Breastfeeding
Terminal condition, with life expectancy of less than 30 days, or palliative care ,such that no actions will be taken to control the source of infection if necessary.Patients receiving palliative care with a life expectancy greater than 30 days maybe included if source control is not necessary or, if necessary, will be carriedout.
Allergy to betalactams
Polymicrobial bacteraemia (except when the other microorganism is considered acontaminant, (e.g. coagulase-negative staphylococci or diphtheroids in a singleblood culture, or in cases where more than one Enterobacteriaceae species isisolated, provided that at least one isolate is resistant to third-generationcephalosporins and both are susceptible to meropenem and temocillin).
Infections typically needing prolonged >14 days of therapy (e.g., endocarditis,prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis)or meningitis. Patients who initially do not have a confirmed diagnosis of theseinfections may be included; if the diagnosis is made subsequently, the patient maybe kept in the trial at the discretion of the investigator, establishing theduration of treatment that he considers necessary.
Active empirical treatment> 96 hours after initial blood culture extraction
Delay in inclusion> 48 h
Recruited in another clinical trial with active treatment
Peritoneal dialysis or continuous hemofiltration
Study Design
Study Description
Connect with a study center
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña 15706
SpainSite Not Available
Hospital ParcTaulí
Sabadell, Barcelona 08208
SpainSite Not Available
Hospital ParcTaulí
Sabadell 3111199, Barcelona 08208
SpainSite Not Available
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona 08221
SpainSite Not Available
Hospital Universitario Mútua Terrassa
Terrassa 3108286, Barcelona 08221
SpainSite Not Available
Hospital Universitario de Cruces
Barakaldo, Bizkaia 48903
SpainSite Not Available
Hospital Universitario de Cruces
Barakaldo 3109453, Bizkaia 48903
SpainSite Not Available
Hospital Marqués de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Marqués de Valdecilla
Santander 3109718, Cantabria 3336898 39008
SpainSite Not Available
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz 11407
SpainSite Not Available
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera 2516326, Cádiz 11407
SpainSite Not Available
Hospital Universitario de Puerto Real
Puerto Real, Cádiz 11510
SpainSite Not Available
Hospital Universitario de Puerto Real
Puerto Real 2512169, Cádiz 11510
SpainSite Not Available
Complejo Hospitalario San Millán-San Pedro De La Rioja
Autol, La Rioja 26560
SpainSite Not Available
Complejo Hospitalario San Millán-San Pedro De La Rioja
Logroño 3118150, La Rioja 3336897 26560
SpainSite Not Available
Complejo Hospitalario de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
Complejo Hospitalario de Navarra
Pamplona 3114472, Navarre 3115609 31008
SpainSite Not Available
Complejo Hospitalario Universitario La Coruña
A Coruña, 15006
SpainSite Not Available
Complejo Hospitalario Universitario La Coruña
A Coruña 3119841, 15006
SpainSite Not Available
Hospital General Universitario de Alicante
Alicante, 03010
SpainSite Not Available
Hospital General Universitario de Alicante
Alicante 2521978, 03010
SpainSite Not Available
Hospital Universitario Torrecárdenas
Almería, 04009
SpainSite Not Available
Hospital Universitario Torrecárdenas
Almería 2521886, 04009
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Sant Pau
Barcelona, 08041
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainActive - Recruiting
Hospital Sant Pau
Barcelona 3128760, 08041
SpainSite Not Available
Hospital del Mar
Barcelona 3128760, 08003
SpainSite Not Available
Hospital Universitario Reina Sofía
Córdoba, 14004
SpainSite Not Available
Hospital Universitario Reina Sofía
Córdoba 2519240, 14004
SpainSite Not Available
Hospital Universitario Clínico San Cecilio
Granada, 18016
SpainSite Not Available
Hospital Universitario Virgen de las Nieves
Granada, 18014
SpainSite Not Available
Hospital Universitario Clínico San Cecilio
Granada 2517117, 18016
SpainSite Not Available
Hospital Universitario Virgen de las Nieves
Granada 2517117, 18014
SpainSite Not Available
Hospital Universitario Juan Ramón Jiménez
Huelva, 21005
SpainSite Not Available
Hospital Universitario Juan Ramón Jiménez
Huelva 2516548, 21005
SpainSite Not Available
Complejo Hospitalario de Jaén
Jaén, 23007
SpainSite Not Available
Hospital Universitario Locus Augusti, Lugo
Lugo, 27003
SpainSite Not Available
Hospital Universitario Locus Augusti, Lugo
Lugo 3117814, 27003
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid, 28007
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario Ramón y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario de la Princesa
Madrid, 28006
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañón
Madrid 3117735, 28007
SpainSite Not Available
Hospital Universitario Ramón y Cajal
Madrid 3117735, 28034
SpainSite Not Available
Hospital Universitario de la Princesa
Madrid 3117735, 28006
SpainSite Not Available
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
SpainSite Not Available
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia 2513416, 30120
SpainSite Not Available
Hospital Regional de Málaga
Málaga, 29010
SpainSite Not Available
Hospital Universitario Virgen de la Victoria
Málaga, 29010
SpainActive - Recruiting
Hospital Regional de Málaga
Málaga 2514256, 29010
SpainSite Not Available
Hospital Universitario Virgen de la Victoria
Málaga 2514256, 29010
SpainSite Not Available
Hospital Universitari Son Espases
Palma, 07120
SpainSite Not Available
Hospital Universitari Son Espases
Palma 2512989, 07120
SpainSite Not Available
Hospital Universitario Virgen Macarena
Sevilla, 41009
SpainActive - Recruiting
Hospital Universitario Virgen de Valme
Sevilla, 41014
SpainSite Not Available
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario Virgen Macarena
Seville 2510911, 41009
SpainSite Not Available
Hospital Universitario Virgen de Valme
Seville 2510911, 41014
SpainSite Not Available
Hospital Universitario Virgen del Rocío
Seville 2510911, 41013
SpainSite Not Available
Complejo Hospitalario Universitario de Vigo
Vigo, 36313
SpainSite Not Available
Complejo Hospitalario Universitario de Vigo
Vigo 3105976, 36313
SpainSite Not Available
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
SpainSite Not Available

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