A Phase 3 interventional study of Pivmecillinam and amoxicillin/clavulanic acid and Standard treatment, ciprofloxacin, trimethoprim/sulfamethoxazole or ertapenem depending on susceptibility in Urinary Tract Infections, Bacteremia and Antibiotic Resistant Infection, sponsored by Lund University. Recruiting at 5 sites in Sweden. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2023-08-28.
Sponsored by Lund University · Phase 3, Interventional, and Treatment
To evaluate if the combination of pivmecillinam and clavulanic acid (PAC) is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE).
A recent observational cohort study supports the notion that beta-lactams can be used with similar efficacy to fluoroquinolones as step down therapy in bacteremic E. coli UTI's. As such, pivmecillinam clavulanic acid (PAC) constitute an appealing per oral alternative, but the combination's safety and efficacy has not been evaluated in a clinical trial The aim of this trial is to investigate whether the PAC combination is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in treating EPE-causing febrile UTI.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's planned enrollment of 330 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical suspicion of UTI including at least one of the following symptoms:
Discontinuing parenteral treatment and starting treatment with oral antibiotics is considered safe according to the treating physician.
EPE refers to ESBL-producing Enterobacterales. This includes Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Klebsiella oxytoca, and Citrobacter koseri.
Susceptibility for pivmecillinam in the study is based on zone diameter breakpoints for pyelonephritis (≥ 20 mm) which was received by personal communication with professor Christian Giske, the chairman of the European Committee of Antimicrobial Susceptibility Testing (EUCAST) (26).
Patients may only be recruited and randomised once in this trial.
Exclusion criteria (any of the following)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pivmecillinam and amoxicillin/clavulanic acid
Drug: Standard treatment, ciprofloxacin, trimethoprim/sulfamethoxazole or ertapenem depending on susceptibility
Drug pages: Amdinocillin Pivoxil · Amoxicillin · Clavulanic Acid
1 tablet pivmecillinam 400 mg and 1 tablet Amoxicillin/clavulanic acid 875/125 mg, three times daily.
Also known as: Coactin or selexid etc, and Augmentin or Clavulin etc
Ciprofloxacin 500 mg twice daily, trimethoprim/sulfamethoxazole 800 mg/160 mg twice daily or ertapenem 1 g once daily.
Also known as: Bactrim
Clinical cure
Clinical cure defined as being alive with absence of fever (≥ 38.3 C) and resolution of, or return to non-infected baseline of, urinary tract symptoms (as defined in inclusion criteria) without additional antibiotic treatment (for UTI symptoms) based on fever control and a semi-structured interview at a live return visit to an independent physician (i.e. not previously involved in the care of the study participant) at an infectious disease clinic.
Time frame: Clinical cure 10 days (+/- 2 days)
To compare the recurrence prevalence of EPE (phenotypically same species) in urine cultures 10 +/- 2 days after antibiotic treatment between groups (i.e., microbiological cure).
Yes or no.
Time frame: Up to 28 days
To compare the prevalence of EPE or carbapenemase-producing bacteria in faecal cultures 10 +/- 2 days after antibiotic treatment between groups.
Yes or no.
Time frame: Up to 28 days
To compare participants' perception of treatment tolerability
Tolerability is measured on a 1-10 scale.
Time frame: 10 days
To compare the incidence of early study drug discontinuation between groups.
Yes or no.
Time frame: 10 days
To compare the incidence of additional antibiotic subscriptions (for UTI) within 28 days between groups.
Yes or no.
Time frame: 28 days
To compare re-admission to hospital (due to UTI-related symptoms) within 28 days between groups.
Yes or no.
Time frame: 28 days
To compare the incidence of drug-related serious adverse events (SAE) within 28 days between groups.
Yes or no.
Time frame: 28 days
To compare the all-cause mortality within 28 days between groups.
Yes or no.
Time frame: 28 days
Plan to share: Undecided — Yes.
Started May 2023 (actual). Primary completion is estimated for Sep 2027, 51 months after the start.
Of 37 phase 3 interventional studies under Urinary Tract Infections, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 32. This study's planned 51 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Amdinocillin Pivoxil · Amoxicillin · Clavulanic Acid