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New treatment option for Urinary Tract Infections
Official title Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
ClinicalTrials.gov ID: NCT05224401
What this study is testing
What is Pivmecillinam and amoxicillin/clavulanic acid?
Pivmecillinam and amoxicillin/clavulanic acid is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for urinary tract infections.
Also referred to as Coactin or selexid etc, and Augmentin or Clavulin etc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130
You may be able to join if
- Age ≥ 18 years
- Fever (≥ 38.3 C) or shaking chills at least once at home or in hospital
- Clinical suspicion of UTI including at least one of the following symptoms:
- Dysuria, urinary urgency, difficulty urinating, new or worsened urinary incontinence, macroscopic haematuria or increased urinary frequency
- Low abdominal pain or flank pain with percussion or palpation tenderness over kidneys and/or bladder.
You likely can't join if
- (any of the following)
- Known or suspected pregnancy.
- Known or suspected life-threatening allergy towards beta-lactam antibiotics.
- Clinical isolate of EPE is resistant to ciprofloxacin, TMX and ertapenem.
- Severe renal insufficiency with estimated glomerular filtration rate (eGFR) \<10mL/min or requiring any form of dialysis.
- Severe decompensated liver failure (i.e., child Pugh class B or C).
See the full eligibility criteria
- Age ≥ 18 years
- Fever (≥ 38.3 C) or shaking chills at least once at home or in hospital
- Clinical suspicion of UTI including at least one of the following symptoms:
- Dysuria, urinary urgency, difficulty urinating, new or worsened urinary incontinence, macroscopic haematuria or increased urinary frequency
- Low abdominal pain or flank pain with percussion or palpation tenderness over kidneys and/or bladder.
- Urine (≥ 103 CFU/mL) and/or blood culture positive for EPE\ with susceptibility to pivmecillinam†.
- In-patient who has received 1-5 days of EPE-active‡ intravenous antibiotics
- 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...
- EPE-active intravenous antibiotics refers to EUCAST susceptibility testing and will most often be piperacillin-tazobactam, meropenem or imipenem-cilastatin in the Swedish setting, and less often aminoglycosides or newer...
- (any of the following)
- Known or suspected pregnancy.
- Known or suspected life-threatening allergy towards beta-lactam antibiotics.
- Clinical isolate of EPE is resistant to ciprofloxacin, TMX and ertapenem.
- Severe renal insufficiency with estimated glomerular filtration rate (eGFR) \<10mL/min or requiring any form of dialysis.
- Severe decompensated liver failure (i.e., child Pugh class B or C).
- Genetic metabolic diseases associated with severe carnitine deficiency.
- Megaloblastic haematopoiesis.
- Co-treatment with valproate or valproic acid (due to interaction with pivmecillinam and ertapenem respectively)
- Other reason to which patient is unfit to be included in the study according to treating physician, e.g., cognitive impairment preventing informed consent and follow-up, inability to speak and/or read Swedish, missing...
The study team makes the final eligibility decision.
Where it's taking place
- Helsingborg, Sweden
- Kristianstad, Sweden
- Lund, Sweden
- Malmö, Sweden
- Västerås, Sweden
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsingborg, Sweden; Kristianstad, Sweden; Lund, Sweden; Malmö, Sweden; Västerås, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.