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Study identifier: NCT07236944 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care

Condition: Febrile Urinary Tract Infection  ·  Sponsor: Uppsala University

PhasePhase 4
Planned participants560
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Thomas Tängdén, MD, Professor  ·  +46 708 370323  ·  thomas.tangden@medsci.uu.se

Lisa Faxén, MD, PhD student  ·  +46 768 721806  ·  lisa.faxen@medsci.uu.se

Always discuss trial participation with your own doctor first.

Locations (13)

Haukeland University HospitalHaukeland, NorwayNot Yet Recruiting
Oslo University HospitalOslo, NorwayNot Yet Recruiting
Södra Älvsborg HospitalBorås, SwedenNot Yet Recruiting
Eskilstuna HospitalEskilstuna, SwedenNot Yet Recruiting
Sahlgrenska University HospitalGothenburg, SwedenRecruiting
Blekinge HospitalKarlskrona, SwedenNot Yet Recruiting
Skåne University HospitalLund, SwedenNot Yet Recruiting
Örebro University HospitalÖrebro, SwedenRecruiting
Karolinska University HospitalStockholm, SwedenNot Yet Recruiting
Sundsvall HospitalSundsvall, SwedenNot Yet Recruiting
Umeå University HospitalUmeå, SwedenNot Yet Recruiting
Uppsala University HospitalUppsala, SwedenRecruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07236944