Oral beta-lactam step down in bacteremic E. coli urinary tract infections.
Stephan Saad, Neil Mina, Colin Lee...
https://pubmed.ncbi.nlm.nih.gov/33087051Actively Recruiting
Phase 3
Age: 18Years - 130Years
All Genders
ID05224401
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales (PACUTI)
Led by Lund University · Updated on 2023-08-28
330
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating if the combination of pivmecillinam and clavulanic acid (PAC) is not less effective than ciprofloxacin, trimethoprim-sulfamethoxazole, or ertapenem for treating febrile urinary tract infections (UTIs) caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE). This phase 3 clinical trial aims to provide clinical evidence on the safety and efficacy of PAC as a step down oral therapy compared to standard treatments in patients with these resistant infections. Participants will be randomly assigned to receive either the experimental PAC treatment, which includes 400 mg pivmecillinam and 875/125 mg amoxicillin/clavulanic acid taken three times daily, or one of the standard treatments: ciprofloxacin 500 mg twice daily, trimethoprim/sulfamethoxazole 800 mg/160 mg twice daily, or ertapenem 1 g once daily, based on susceptibility. The treatments are given orally as step down therapy following initial intravenous antibiotics. The trial compares these treatments to assess non-inferiority in clinical cure and other outcomes. During the study, participants will be monitored for clinical cure approximately 10 days after treatment, with follow-up visits up to 28 days to assess recurrence of infection, microbiological cure, treatment tolerability, drug discontinuation rates, additional antibiotic use, hospital readmissions, serious adverse events, and mortality. Data collection includes urine and fecal cultures, patient questionnaires on treatment tolerability, and safety monitoring. The total study duration includes the treatment period and post-treatment follow-up to evaluate outcomes and safety.
CONDITIONS
Brief Title
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
Who Can Participate
Age: 18Years - 130Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Fever (38.3°C or higher) or shaking chills at least once at home or in hospital
- Clinical suspicion of urinary tract infection with symptoms such as dysuria, urinary urgency, difficulty urinating, new or worsened urinary incontinence, visible blood in urine, or increased urinary frequency
- Low abdominal or flank pain with tenderness over kidneys and/or bladder
- Urine (≥ 10^3 CFU/mL) and/or blood culture positive for ESBL-producing Enterobacterales with susceptibility to pivmecillinam
- Inpatient who has received 1 to 5 days of intravenous antibiotics active against ESBL-producing bacteria
- Starting oral antibiotic treatment after stopping intravenous therapy is considered safe by the treating physician
- Patients may only be recruited and randomized once in this trial
You will not qualify if you...
- Known or suspected pregnancy
- Known or suspected life-threatening allergy to beta-lactam antibiotics
- Bacterial isolate resistant to ciprofloxacin, trimethoprim-sulfamethoxazole, and ertapenem
- Severe kidney failure with estimated glomerular filtration rate (eGFR) below 10 mL/min or requiring dialysis
- Severe decompensated liver failure (Child Pugh class B or C)
- Genetic metabolic diseases causing severe carnitine deficiency
- Megaloblastic blood cell formation
- Taking valproate or valproic acid medications
- Unfit for inclusion due to reasons like cognitive impairment, inability to speak or read Swedish, missing personal identification or phone number, or planned antibiotic treatment longer than 10 days due to complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 10 days
Participants receive oral antibiotic treatment with either pivmecillinam and amoxicillin/clavulanic acid or standard antibiotics such as ciprofloxacin, trimethoprim-sulfamethoxazole, or ertapenem as step down therapy after intravenous antibiotics.
Visits during treatment as determined by their physician
Follow-up
Duration - Up to 28 days after treatment
Participants are monitored for clinical cure, recurrence of infection, treatment tolerability, and any adverse events after completing antibiotic treatment.
1 to 2 visits within 28 days after treatment
Trial Site Locations
Total: 5 locations
1
Helsingborg hospital
Helsingborg, Sweden
Actively Recruiting
2
Kristianstad hospital
Kristianstad, Sweden
Actively Recruiting
3
Skåne University Hospital, Lund
Lund, Sweden
Actively Recruiting
4
Skåne University Hospital, Malmö
Malmö, Sweden
Actively Recruiting
5
Västmanland hospital Västerås
Västerås, Sweden
Actively Recruiting
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Research Team
O
Oskar Ljungquist, M.D, PhD
J
Jonas Tverring, M.D, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Pivmecillinam with Amoxicillin/Clavulanic acid as step down oral therapy in febrile Urinary Tract Infections caused by ESBL-producing Enterobacterales (PACUTI).
Jonas Tverring, Emeli Månsson, Vigith Andrews...
https://pubmed.ncbi.nlm.nih.gov/37660037