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Clinical Trials/2024-520251-24-00
2024-520251-24-00RecruitingPhase 4

Evidence based empirical antibiotic treatment for urinary tract infections requiring hospitalisation - TRI-AB trial

Odense University Hospital7 sites in 1 country618 target enrollmentStarted: January 5, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
618
Locations
7
Primary Endpoint
Clinical cure on day 3 (resolution of cUTI-related symptoms and fever, together with clinical improvement and no need for escalating systemic antimicrobial therapy)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To assess whether tablet pivmecillinam 800 mg three times daily combined with a single iv dose of gentamicin 5 mg/kg is non-inferior to current standard empirical treatments (iv ampicillin plus gentamicin or iv piperacillin/tazobactam) for achieving clinical cure on day 3 in hospitalised adults with cUTI

Study Design

Allocation
Randomized
Primary Purpose
Tri-ab
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age ≥18 years
  • •Hospitalised with symptoms and/or signs of acute pyelonephritis or lower cUTI
  • •Empirical intravenous antibiotic treatment is planned by the treating physician

Exclusion Criteria

  • •quick Sequential Organ Failure Assessment Score (qSOFA) ≥2 (qSOFA score allocates one point for each of the following criteria: respiratory rate ≥22/min, altered mental status, and systolic blood pressure ≤100 mmHg)
  • •Known myasthenia gravis
  • •Acute mononucleosis or porphyria
  • •Pre-existing complicated urogenital conditions
  • •Current or earlier treatment with cisplatin and/or carboplatin
  • •Descent from the Faroe Islands without prior negative screening for Carnitine Transporter Deficiency (CTD)
  • •Receipt of iv antibiotics covering cUTI prior to enrollment
  • •Kidney transplant recipients or patients on hemodialysis or periotoneal dialysis
  • •Informed consent prior to inclusion unobtainable.
  • •estimated Glomerular Filtration Rate <30ml/min/1.73m^2
  • •Urine culture within 72 hours showing a microorganism resistant to one of the study regimens
  • •Known allergy or hypersensitivity to pivmecillinam, penicillins, cephalosporins, aminoglycosides or excipients
  • •Pregnancy or breastfeeding
  • •Inability to ingest oral medication

Arms & Interventions

PIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Comparator

Intervention: PIPERACILLIN AND BETA-LACTAMASE INHIBITOR (Drug)

PIVMECILLINAM

Test

Intervention: PIVMECILLINAM (Drug)

AMPICILLIN

Comparator

Intervention: AMPICILLIN (Drug)

GENTAMICIN

Test

Intervention: GENTAMICIN (Drug)

Outcomes

Primary Outcomes

Clinical cure on day 3 (resolution of cUTI-related symptoms and fever, together with clinical improvement and no need for escalating systemic antimicrobial therapy)

Clinical cure on day 3 (resolution of cUTI-related symptoms and fever, together with clinical improvement and no need for escalating systemic antimicrobial therapy)

Secondary Outcomes

  • 30/90/365-day mortality
  • Microbiological cure on Day 3
  • Time to oral-only antibiotic therapy
  • Length of hospital stay
  • Antibiotic treatment duration (combined iv and oral)
  • Nephrotoxicity within 30 days
  • Proportion of treatment-related serious adverse reactions (SAE) and suspected unexpected serious adverse reactions (SUSAR)
  • Secondary infections (C. difficile or genital/oral Candida within 30 days of enrollment)
  • Hospital readmission within 90 days due to UTI
  • Post-discharge antibiotic prescription redemption within 90 days for UTI associated antibiotics.

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

TRI-AB

Scientific

Odense University Hospital

Study Sites (7)

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