Actively Recruiting
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
Led by Lund University · Updated on 2023-08-28
330
Participants Needed
5
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Fever of 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, increased urinary frequency, low abdominal pain, or flank pain with tenderness
- Urine and/or blood culture positive for ESBL-producing Enterobacterales with susceptibility to pivmecillinam
- Hospitalized patient who has received 1 to 5 days of intravenous antibiotics active against ESBL-producing Enterobacterales
- Treating physician considers it safe to switch from intravenous to oral antibiotic treatment
You will not qualify if you...
- Known or suspected pregnancy
- Known or suspected life-threatening allergy to beta-lactam antibiotics
- Infection with bacteria resistant to ciprofloxacin, trimethoprim-sulfamethoxazole, and ertapenem
- Severe kidney failure with eGFR less than 10 mL/min or requiring dialysis
- Severe decompensated liver failure (Child Pugh class B or C)
- Genetic metabolic diseases causing severe carnitine deficiency
- Megaloblastic hematopoiesis
- Taking valproate or valproic acid
- Unfit for study inclusion due to cognitive impairment, inability to communicate in Swedish, missing national ID number or phone number, or need for antibiotic treatment longer than 10 days due to complications
AI-Screening
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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
Research Team
O
Oskar Ljungquist, M.D, PhD
CONTACT
J
Jonas Tverring, M.D, PhD
CONTACT
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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