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Pivmecillinam as oral step-down treatment for Escherichia coli febrile urinary tract infection versus standard of care; a randomized controlled non-inferiority multicenter trial
EU CTIS ID: 2023-503447-33-00
What this study is testing
The primary objective is to investigate if the clinical response with oral follow-up treatment with pivmecillinam 400 mg QID is non-inferior to standard of care in patients with E. coli fUTI 7 (+/-2) days after end of treatment (EOT).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age.
- Diagnosis of fUTI, defined as i) fever ≥ 38°C measured in a healthcare institution and ii) at least one of the following: flank pain or pelvic pain, nausea or vomiting, dysuria, urinary frequency or urgency, and costovertebral angle tenderness on physical examination.
- Growth of E. coli in urine with antimicrobial susceptibility to mecillinam.
- Adequate intravenous antibiotic treatment for fUTI (defined below) for >=2 days to which the isolated E. coli is determined susceptible.
- Defervescence and hemodynamic stability for at least 24 hours, according to the responsible physician.
- Signed informed consent.
You likely can't join if
- Adequate intravenous antibiotic treatment for > 4 days prior to randomization or other adequate (microbiologically active) oral antibiotic treatment for the same fUTI episode prior to recruitment.
- Other intravenous or oral antibiotic treatment; ongoing or planned during the follow-up period (i.e. until 28 days after EOT for fUTI).
- Severe renal impairment (eGFR < 20 mL/min) at randomization.
- Morbid obesity (BMI > 40 kg/m2).
- Pregnancy or breastfeeding.
- Unlikely to follow instructions or the study protocol.
See the full eligibility criteria
- ≥18 years of age.
- Diagnosis of fUTI, defined as i) fever ≥ 38°C measured in a healthcare institution and ii) at least one of the following: flank pain or pelvic pain, nausea or vomiting, dysuria, urinary frequency or urgency, and costovertebral angle tenderness on physical examination.
- Growth of E. coli in urine with antimicrobial susceptibility to mecillinam.
- Adequate intravenous antibiotic treatment for fUTI (defined below) for >=2 days to which the isolated E. coli is determined susceptible.
- Defervescence and hemodynamic stability for at least 24 hours, according to the responsible physician.
- Signed informed consent.
- Adequate intravenous antibiotic treatment for > 4 days prior to randomization or other adequate (microbiologically active) oral antibiotic treatment for the same fUTI episode prior to recruitment.
- Other intravenous or oral antibiotic treatment; ongoing or planned during the follow-up period (i.e. until 28 days after EOT for fUTI).
- Severe renal impairment (eGFR < 20 mL/min) at randomization.
- Morbid obesity (BMI > 40 kg/m2).
- Pregnancy or breastfeeding.
- Unlikely to follow instructions or the study protocol.
- Previous participation in the study.
- If consenting to microbiome analysis: i) contraindication for ciprofloxacin (e.g. allergy), ii) unlikely to be able to provide fecal samples per protocol, iii) treatment with antibiotics in the past 3 months before the current fUTI episode, iv) chronic intestinal disease or previous surgery in the gastrointestinal tract.
- If consenting to pharmacokinetic analysis: expected difficulties in taking blood and urine samples per protocol.
- Growth of other bacterial species than E. coli, or fungi, in urine.
- Contraindication for pivmecillinam (e.g. allergy).
- Clinical suspicion of bacterial prostatitis.
- Renal abscess.
- Kidney transplant.
- Myelosuppressive disorder with neutrophil count < 0.5 x 10^9/L at randomization.
- Planned antibiotic treatment for fUTI > 14 days.
- Likely to be prescribed antibiotic prophylaxis after treatment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.