A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant Enterobacteriaceae. The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
The objective of the trial is to demonstrate the non-inferiority of temocillin (2g each 8 hours, intravenous) to carbapenems (meropenem 1g each 8 hours, intravenous) in terms of efficacy and safety in the targeted treatment of bacteraemia due to Enterobacteriaceae resistant to third-generation cephalosporins, and therefore provide evidence for the use of temocillin in these infections. The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
334
The intervention of experimental arm will be Intravenous administration of temocillin.
The intervention of comparator arm will be intravenous administration of meropenem.
Hospital ParcTaulí
Sabadell, Barcelona, Spain
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Number of participants with a "success" at the test of cure (TOC)
A success at the test of cure is the resolution of infection symptoms
Time frame: Up to 7-10 days after the last day of antibiotic therapy
Survival at day 28
Number of patients who are alive
Time frame: At day 28.
Number of patients who do not need to stop or change the assigned drug
Reasons for not change can be no adverse event, no perceived failure during treatment or no occurrence of a superimposed infection. Participants who stop or change the assigned drug will not meet the primary outcome.
Time frame: Up to 7-14 days after the last day of antibiotic therapy
Number of patients who do not need to prolong therapy beyond 14 days
Assigned treatment to be administered for less than 14 days
Time frame: Up to 7-14 days after the last day of antibiotic therapy
Not recurrence until day 28
Recurrence is reappearance of symptoms with positive blood culture for the same microorganism. Participants with recurrence will not meet the primary outcome.
Time frame: At day 28.
28-day mortality
Number of patients dead up to day 28.
Time frame: Up to day 28.
Length of hospital stay (days)
Number of days patients has been in-hospital
Time frame: Through study completion, an average of 28 days
Length of intravenous therapy (days)
Number of days patients has been under intravenous antibiotic treatment
Time frame: From day 1 of intravenous antibiotic treatment administration to last intravenous administration, average 14 days
Length of total administration of therapy (days)
Number of days patients has been under intravenous or oral antibiotic treatment
Time frame: From day 1 of intravenous or oral antibiotic treatment administration to last intravenous or oral administration, average 14 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to day 28
Number of subjects with resistance development during therapy
Resistance development will be measured in a positive blood culture
Time frame: Up to day 28
Recurrence rate
Percentage of subjects with recurrence
Time frame: Up to day 28.
Changes in Sequential Organ failure (SOFA) score
Sequential Organ failure (SOFA) score changes
Time frame: At days 1, 3, end of treatment (days 7-14) and visit 4
Changes in Barthel Index for Activities of Daily Living (ADL) for patients older than 70 years old
Barthel Index for Activities of Daily Living (ADL) score changes; score from 0, completely dependent patient to 100, completely independent for activities of daily living
Time frame: At days 1, 3, end of treatment (days 7-14) and visit 4
Number of subjects with development of superimposed infections.
Development of superimposed infections will be measured in a positive culture
Time frame: Up to day 28.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Universitario de Puerto Real
Puerto Real, Cádiz, Spain
Complejo Hospitalario San Millán-San Pedro De La Rioja
Logroño, La Rioja, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Complejo Hospitalario Universitario La Coruña
A Coruña, Spain
Hospital General Universitario de Alicante
Alicante, Spain
...and 19 more locations