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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003898-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temocillin | Experimental | 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. |
|
| Cefotaxime | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temocillin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 12 hours after the last dose of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7-10 days after discontinuation of antibiotic treatment (parenteral and oral). |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | From the first dose of study drug until 4-6 weeks after discontinuation of antibiotic treatment (parenteral and per oral). |
Inclusion Criteria:
Males and females ≥ 18 years of age with suspected or confirmed febrile UTI, fulfilling at least one of the following signs and symptoms:
Fever ≥ 38.0°C (highest temperature recorded at home or at the hospital)
Positive urinalysis tests (U-Nitrit and/or U-LPK)
Have a pre-treatment baseline urinary culture obtained
Require iv antibacterial treatment of the presumed infection
Fertile women: Agree to practice highly effective anti-contraceptive methods from study-start to TOC
Signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Håkan Hanberger, Professor | University Hospital, Linkoeping | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Solna | Stockholm County | 171 76 | Sweden | ||
| Helsingborg Hospital |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 11, 2021 | |
| Reset | Jun 4, 2021 |
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|
| Cefotaxime | 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. |
|
|
| Number of patients with early clinical response. | Non-inferiority analysis. | 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. | 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. | Within 12 hours after the 9th dose of study drug. |
| Rate of patients with diarrhea (≥ 3 loose stools per day) | From the first dose of study drug until 7-10 days after discontinuation of antibiotic treatment (parenteral and oral). |
| Helsingborg |
| 251 87 |
| Sweden |
| Centralsjukhuset Kristianstad | Kristianstad | 291 85 | Sweden |
| Linköping University Hospital | Linköping | 581 85 | Sweden |
| Skåne University Hospital | Lund | 221 85 | Sweden |
| Vrinnevisjukhuset i Norrköping | Norrköping | 601 82 | Sweden |
| Örebro University Hospital | Örebro | 701 85 | Sweden |
| Östersund Hospital | Östersund | 83131 | Sweden |
| Capio S:t Görans hospital | Stockholm | 112 81 | Sweden |
| Sundsvall Hospital | Sundsvall | 856 43 | Sweden |
| University Hospital of Umeå | Umeå | 901 85 | Sweden |
| Västmanlands sjukhus i Västerås | Västerås | 721 89 | Sweden |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2021 | Jun 4, 2021 |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C031367 | temocillin |
| D002439 | Cefotaxime |
| ID | Term |
|---|---|
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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