NCT05224401 Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
| NCT ID | NCT05224401 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Lund University |
| Condition | Urinary Tract Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2023-05-29 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 330 participants in total. It began in 2023-05-29 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Fever (≥ 38.3 C) or shaking chills at least once at home or in hospital 3. Clinical suspicion of UTI including at least one of the following symptoms: 1. Dysuria, urinary urgency, difficulty urinating, new or worsened urinary incontinence, macroscopic haematuria or increased urinary frequency 2. Low abdominal pain or flank pain with percussion or palpation tenderness over kidneys and/or bladder. 4. Urine (≥ 103 CFU/mL) and/or blood culture positive for EPE\* with susceptibility to pivmecillinam†. 5. In-patient who has received 1-5 days of EPE-active‡ intravenous antibiotics 6. 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). * 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 beta-lactamase-inhibitor-containing beta-lactam antibiotics (27). Participants who have only received one dose of EPE-active intravenous antibiotics are also eligible and are considered within the "1-5 days" of antibiotics. Patients may only be recruited and randomised once in this trial. Exclusion criteria (any of the following) 1. Known or suspected pregnancy. 2. Known or suspected life-threatening allergy towards beta-lactam antibiotics. 3. Clinical isolate of EPE is resistant to ciprofloxacin, TMX and ertapenem. 4. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) \<10mL/min or requiring any form of dialysis. 5. Severe decompensated liver failure (i.e., child Pugh class B or C). 6. Genetic metabolic diseases associated with severe carnitine deficiency. 7. Megaloblastic haematopoiesis. 8. Co-treatment with valproate or valproic acid (due to interaction with pivmecillinam and ertapenem respectively) 9. 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 national personal identification number or missing telephone number preventing follow-up or planned duration of antibiotics \> 10 days due to complicating factors.
Contact & Investigator
Oskar Ljungquist, MD, PhD.
PRINCIPAL INVESTIGATOR
Lunds universitet
Frequently Asked Questions
Who can join the NCT05224401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05224401 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 330 participants.
Is NCT05224401 currently recruiting?
Yes, NCT05224401 is actively recruiting participants. Contact the research team at oskar.ljungquist@med.lu.se for enrollment information.
Where is the NCT05224401 trial being conducted?
This trial is being conducted at Helsingborg, Sweden, Kristianstad, Sweden, Lund, Sweden, Malmö, Sweden and 1 additional location.
Who is sponsoring the NCT05224401 clinical trial?
NCT05224401 is sponsored by Lund University. The principal investigator is Oskar Ljungquist, MD, PhD. at Lunds universitet. The trial plans to enroll 330 participants.