Disturbance of the Intestinal Microbiota by Temocillin vs Cefotaxime in Treatment of Febrile Urinary Tract Infections
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02959957|
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Drug: Temocillin Drug: Cefotaxime||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled, Multicentre Trial of Collateral Damage on the Intestinal Microbiota Inferred by Temocillin Versus Cefotaxime in Patients Receiving Empirical Treatment for Febrile Urinary Tract Infections|
|Actual Study Start Date :||May 20, 2016|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||August 2019|
Temocillin powder for solution för injection/infusion, per day 6 g (2 g three times per day). Treatment length 7-10 days of which at least 3 days administration with the study drug.
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.
Other Name: Negaban
Active Comparator: Cefotaxime
Cefotaxime powder for solution för injection/infusion, per day 3-6 g (1-2 g three times per day). Treatment length 7-10 days of which at least 3 days administration with the study drug.
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.
Other Name: Claforan
- 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. [ Time Frame: Within 12 hours after the last dose of study drug. ]Superiority analysis.
- Number of patients with clinical cure in each treatment group. [ Time Frame: 7-10 days after discontinuation of antibiotic treatment (parenteral and oral). ]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.
- Number of patients with early clinical response. [ Time Frame: Within 12 hours after the 9th dose of study drug. ]Non-inferiority analysis.
- Bacteriological cure per patient and per pathogen measured as negative urine Culture <1000 CFU/ml. [ Time Frame: 7-10 days after discontinuation of antibiotic treatment (parenteral and oral). ]Non-inferiority analysis.
- Early bacteriological response measured as negative urine Culture <1000 CFU/ml. [ Time Frame: Within 12 hours after the 9th dose of study drug. ]Non-inferiority analysis.
- 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). ]
- Frequency of adverse events [ Time Frame: From the first dose of study drug until 4-6 weeks after discontinuation of antibiotic treatment (parenteral and per oral). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959957
|Karolinska University Hospital|
|Solna, Stockholm, Sweden, 171 76|
|Helsingborg, Sweden, 251 87|
|Kristianstad, Sweden, 291 85|
|Linköping University Hospital|
|Linköping, Sweden, 581 85|
|Skåne University Hospital|
|Lund, Sweden, 221 85|
|Vrinnevisjukhuset i Norrköping|
|Norrköping, Sweden, 601 82|
|Capio S:t Görans hospital|
|Stockholm, Sweden, 112 81|
|Sundsvall, Sweden, 856 43|
|University Hospital of Umeå|
|Umeå, Sweden, 901 85|
|Västmanlands sjukhus i Västerås|
|Västerås, Sweden, 721 89|
|Örebro University Hospital|
|Örebro, Sweden, 701 85|
|Östersund, Sweden, 83131|
|Principal Investigator:||Håkan Hanberger, Professor||University Hospital, Linkoeping|