This study will evaluate the ecological impact on the intestinal microbiota and compare the safety and efficacy of temocillin compared to cefotaxime, in empiric treatment of febrile UTI. Half of participants will receive temocillin and the other half will receive cefotaxime.
Temocillin is a narrow spectrum antibiotic with activity against gram negative bacteria inclusive many ESBL producing bacteria. Temocillin is approved and marketed in a few European countries since the 1980´s but not in Sweden. The aim of the study is to find an ecological favorable alternative to cephalosporins in the treatment of this common indication. The hypothesis is that treatment with temocillin causes less disturbances on the intestinal microbiota while at least comparable efficacy. The study will be performed as an open prospective multicentre study with two parallel groups comparing 2 g temocillin three times daily with 1-2 g cefotaxim three times daily for 7-10 days in male and female adult patients with febrile urinary tract infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
157
Total antibiotic treatment 7-10 days, of which at least 72 hours (9 doses) initial temocillin administration. In case of bacteraemia at baseline the total antibiotic treatment can be extended up to 14 days.
Total antibiotic treatment 7-10 days, of which at least 72 hours (9 doses) initial cefotaxime administration. In case of bacteraemia at baseline the total antibiotic treatment can be extended up to 14 days.
Karolinska University Hospital
Solna, Stockholm County, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Centralsjukhuset Kristianstad
Kristianstad, Sweden
Number of patients with emergence of any of the two following events: Colonisation or infection with C. difficile and/or with Enterobacteriaceae resistant to 3rd generation cephalosporins. Measured in cultures from faecal samples.
Superiority analysis.
Time frame: Within 12 hours after the last dose of study drug.
Number of patients with clinical cure in each treatment group.
Clinical cure defined as patient totally recovered with no remaining symptoms of UTI or no recurrence with symptoms or no need of further treatment against the current infection. Non-inferiority analysis.
Time frame: 7-10 days after discontinuation of antibiotic treatment (parenteral and oral).
Number of patients with early clinical response.
Non-inferiority analysis.
Time frame: Within 12 hours after the 9th dose of study drug.
Bacteriological cure per patient and per pathogen measured as negative urine Culture <1000 CFU/ml.
Non-inferiority analysis.
Time frame: 7-10 days after discontinuation of antibiotic treatment (parenteral and oral).
Early bacteriological response measured as negative urine Culture <1000 CFU/ml.
Non-inferiority analysis.
Time frame: Within 12 hours after the 9th dose of study drug.
Rate of patients with diarrhea (≥ 3 loose stools per day)
Time frame: From the first dose of study drug until 7-10 days after discontinuation of antibiotic treatment (parenteral and oral).
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Linköping University Hospital
Linköping, Sweden
Skåne University Hospital
Lund, Sweden
Vrinnevisjukhuset i Norrköping
Norrköping, Sweden
Örebro University Hospital
Örebro, Sweden
Östersund Hospital
Östersund, Sweden
Capio S:t Görans hospital
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Sundsvall Hospital
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...and 2 more locations