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Compares treatment options for Febrile Urinary Tract Infection
Official title Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care
ClinicalTrials.gov ID: NCT07236944
What this study is testing
What is Pivmecillinam?
Pivmecillinam is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for febrile urinary tract infection.
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
- The goal of this clinical trial is to learn if oral treatment with pivmecillinam is effective to treat febrile urinary tract infections in adult patients. Hospitalized patients who have received 2-4 days of intravenous antibiotic therapy for febrile urinary tract infections, and have responded to treatment, will be randomized to either pivmecillinam or standard treatment (other oral or intravenous antibiotics).
- Phase 4: studies an already-approved treatment
- 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 and older
You may be able to join if
- ≥18 years of age.
- Diagnosis of fUTI, defined as i) fever ≥ 38°C and ii) at least one of the following: flank pain or pelvic pain, nausea or vomiting, dysuria, urinary...
- 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.
You likely can't join if
- Adequate intravenous antibiotic treatment for \> 4 days prior to randomization or other adequate (microbiologically active) oral antibiotic treatment...
- 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.
See the full eligibility criteria
- ≥18 years of age.
- Diagnosis of fUTI, defined as i) fever ≥ 38°C 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...
- 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.
- Planned treatment with one of the following antibiotics, should the patient be assigned by chance to the standard-of-care arm. Intravenous antibiotics: 1) Penicillins; ampicillin, piperacillin/tazobactam, ≥2)...
- 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.
- 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.
- 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...
- If consenting to pharmacokinetic analysis: expected difficulties in providing blood and urine samples per protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Haukeland, Norway
- Oslo, Norway
- Borås, Sweden
- Eskilstuna, Sweden
- Gothenburg, Sweden
- Karlskrona, Sweden
- Lund, Sweden
- Örebro, Sweden
- Stockholm, Sweden
- Sundsvall, Sweden
- Umeå, Sweden
- Uppsala, Sweden
- Vaxjo, Sweden
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haukeland, Norway; Oslo, Norway; Borås, Sweden; Eskilstuna, Sweden; Gothenburg, Sweden; Karlskrona, Sweden and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.