Actively Recruiting
Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care
Led by Uppsala University · Updated on 2025-12-17
560
Participants Needed
13
Research Sites
169 weeks
Total Duration
On this page
Sponsors
U
Uppsala University
Lead Sponsor
T
The Swedish Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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). The main question the study aims to answer is if oral follow-up with pivmecillinam is as effective as standard treatment. Patients will be evaluated for clinical response (resolution of fever and urinary tract symptoms) and microbiological response (no growth of bacteria in urine) 7 and 28 days after the end of treatment. Patients will also be asked about side effects. Some of the participants will also be examined for changes in the gut microbiome and drug exposures in blood and urine. Participants will: 1. Keep a patient diary to record antibiotic intake, body temperature, urinary tract symptoms, and suspected side effects until 7 days after end of treatment. 2. Participate in phone interviews 7 and 28 days after end of treatment to assess clinical response. 3. Provide urine samples 7 and 28 days after end of treatment to evaluate microbiological response. 4. A subgroup (60 patients) will provide fecal samples at five time-points over three months to assess antibiotic-induced changes in the gut microbiome. 5. A subgroup (30 patients) treated with to pivmecillinam will provide blood and urine samples to determine the pharmacokinetics of mecillinam during one dosing interval.
CONDITIONS
Official Title
Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosis of febrile urinary tract infection with fever of 38°C or higher and at least one symptom such as flank pain, pelvic pain, nausea, vomiting, painful urination, frequent urination, or kidney tenderness
- Growth of Escherichia coli in urine that is susceptible to mecillinam
- Received 2 to 4 days of adequate intravenous antibiotic treatment for febrile urinary tract infection to which the isolated E. coli is susceptible
- Defervescence and hemodynamic stability for at least 24 hours as assessed by the responsible physician
- Planned treatment with specified antibiotics if randomized to standard-of-care group
- Signed informed consent
You will not qualify if you...
- Received more than 4 days of adequate intravenous antibiotic treatment or other adequate oral antibiotic treatment for the same infection before randomization
- Growth of bacteria other than E. coli or fungi in urine
- Allergy or contraindication to pivmecillinam
- Clinical suspicion of bacterial prostatitis
- Presence of renal abscess
- Kidney transplant recipient
- Myelosuppressive disorder with very low neutrophil count at randomization
- Planned antibiotic treatment for febrile urinary tract infection longer than 14 days
- Likely to require antibiotic prophylaxis after treatment
- Use or planned use of other antibiotics during the follow-up period up to 28 days after treatment
- Severe kidney impairment (eGFR less than 20 mL/min) at randomization
- Morbid obesity (BMI over 40 kg/m2)
- Pregnancy or breastfeeding
- Unlikely to comply with study instructions or protocol
- Previous participation in this study
- For microbiome analysis participants: allergy to ciprofloxacin, inability to provide fecal samples as required, recent antibiotic use within 3 months, chronic intestinal disease or prior gastrointestinal surgery
- For pharmacokinetic analysis participants: expected difficulties providing blood and urine samples as required
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Trial Site Locations
Total: 13 locations
1
Haukeland University Hospital
Haukeland, Norway
Not Yet Recruiting
2
Oslo University Hospital
Oslo, Norway
Not Yet Recruiting
3
Södra Älvsborg Hospital
Borås, Sweden
Not Yet Recruiting
4
Eskilstuna Hospital
Eskilstuna, Sweden
Not Yet Recruiting
5
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
6
Blekinge Hospital
Karlskrona, Sweden
Not Yet Recruiting
7
Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
8
Örebro University Hospital
Örebro, Sweden
Actively Recruiting
9
Karolinska University Hospital
Stockholm, Sweden
Not Yet Recruiting
10
Sundsvall Hospital
Sundsvall, Sweden
Not Yet Recruiting
11
Umeå University Hospital
Umeå, Sweden
Not Yet Recruiting
12
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
13
Central Hospital Växjö
Vaxjo, Sweden
Not Yet Recruiting
Research Team
T
Thomas Tängdén, MD, Professor
CONTACT
L
Lisa Faxén, MD, PhD student
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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