Urinary Tract InfectionsPhase 4NCT02959957
Disturbance of the Intestinal Microbiota by Temocillin vs Cefotaxime in Treatment of Febrile Urinary Tract Infections
A Phase 4 study testing Temocillin and Cefotaxime in people with Urinary Tract Infections, run by Håkan Hanberger at 12 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Temocillin and Cefotaxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 12 sitesSweden
- Study dates
- 20 May 2016to Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age with suspected or confirmed febrile UTI, fulfilling at least one of the following signs and symptoms:
- Flank pain or suprapubic pain, Tenderness over the kidney on physical examination, Urinary symptoms such as dysuria, urinary frequency or urinary urgency
- 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
Who cannot join
- Have a documented history of hypersensitivity or allergic reaction to any beta-lactam
- Pregnant or nursing women
- Receipt of any prior potentially therapeutic antibacterial agent within 1 month before randomisation and sampling for urine and faecal cultures. Exceptions will prior treatment with pivmecillinam or nitrofurantoin.
- Known chronic renal insufficiency (creatinine clearance < 10 mL/min at screening as estimated by Cockcroft-Gault), or receiving intermittent haemodialysis or peritoneal dialysis
- Known colonization with ESBL
- Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Sweden12 sites
Helsingborg Hospital
Helsingborg, 251 87
Centralsjukhuset Kristianstad
Kristianstad, 291 85
Linköping University Hospital
Linköping, 581 85
Skåne University Hospital
Lund, 221 85
Vrinnevisjukhuset i Norrköping
Norrköping, 601 82
Örebro University Hospital
Örebro, 701 85
Östersund Hospital
Östersund, 83131
Karolinska University Hospital
Solna, Stockholm County, 171 76
Capio S:t Görans hospital
Stockholm, 112 81
Sundsvall Hospital
Sundsvall, 856 43
University Hospital of Umeå
Umeå, 901 85
Västmanlands sjukhus i Västerås
Västerås, 721 89
About this study
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
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.
Read the detailed description
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.
- Conditions
- Urinary Tract Infections
- Being tested
- Temocillin, Cefotaxime
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemocillinDrug
Also called Negaban
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.
CefotaximeDrug
Also called Claforan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Temocillin |
| 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. Receives: Drug: Cefotaxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 hours after the last dose of study drug.
Secondary outcomes (5)
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.
Measured: 7-10 days after discontinuation of antibiotic treatment (parenteral and oral).
Number of patients with early clinical response.
Non-inferiority analysis.
Measured: 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.
Measured: 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.
Measured: Within 12 hours after the 9th dose of study drug.
Rate of patients with diarrhea (≥ 3 loose stools per day)
Measured: From the first dose of study drug until 7-10 days after discontinuation of antibiotic treatment (parenteral and oral).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start20 May 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Håkan Hanberger
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Håkan Hanberger, Public Health Agency of Sweden
- Investigators
- Håkan Hanberger, Professor, Principal investigator, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959957
- Sponsor's protocol ID
- FoHM/UVI 2015
- Other IDs
- 2015-003898-15, 2015
- Status last verified
- Sep 2019
- First submitted
- 13 Oct 2016
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02959957
- Acronym / sponsor ID
- FoHM/UVI 2015
- Conditions
- Urinary Tract Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Håkan HanbergerOther government
- Study start
- 20 May 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temocillin | Experimental | Drug: TemocillinTemocillin 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 | Drug: CefotaximeCefotaxime 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Have a documented history of hypersensitivity or allergic reaction to any beta-lactam
- Pregnant or nursing women
- Receipt of any prior potentially therapeutic antibacterial agent within 1 month before randomisation and sampling for urine and faecal cultures. Exceptions will prior treatment with pivmecillinam or nitrofurantoin.
- Known chronic renal insufficiency (creatinine clearance < 10 mL/min at screening as estimated by Cockcroft-Gault), or receiving intermittent haemodialysis or peritoneal dialysis
- Known colonization with ESBL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemocillinAlso: NegabanTotal 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. | Drug | Temocillin |
| CefotaximeAlso: ClaforanTotal 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. | Drug | Cefotaxime |
Primary outcome
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.
5 secondary outcomes
Number of patients with clinical cure in each treatment group.
Time frame: 7-10 days after discontinuation of antibiotic treatment (parenteral and oral).
Number of patients with early clinical response.
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.
Time frame: 7-10 days after discontinuation of antibiotic treatment (parenteral and oral).
Early bacteriological response measured as negative urine Culture <1000 CFU/ml.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håkan Hanberger, Professor principal investigator
University Hospital, Linkoeping
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Temocillin and Cefotaxime in people with Urinary Tract Infections, run by Håkan Hanberger at 12 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.