TRI-AB trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

4 May 2026 → ongoing

Decision date (initial)

2026-03-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

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

Secondary objectives 8

1. To assess all-cause mortality at Days 30, 90 and 365
2. To assess microbiological efficacy, specifically the proportion of patients achieving microbiological cure (eradication of baseline uropathogens) on Day 3
3. To assess time to oral-only antibiotic therapy
4. To assess total duration of antibiotic treatment (combined intravenous and oral)
5. To assess length of hospital stay
6. To assess incidence of treatment failure and relapse within 90 days post-enrollment
7. To assess incidence of treatment-related adverse events, including acute kidney injury, nephrotoxicity, and secondary infections such as Clostridioides difficile or candidiasis
8. To assess post-discharge antibiotic prescription redemption within 90 days

Conditions and MedDRA coding

Complicated urinary tract infections (cUTI) requiring hospitalisation

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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

Exclusion criteria 14

1. 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)
2. Receipt of iv antibiotics covering cUTI prior to enrollment
3. Kidney transplant recipients or patients on hemodialysis or periotoneal dialysis
4. Informed consent prior to inclusion unobtainable.
5. estimated Glomerular Filtration Rate <30ml/min/1.73m^2
6. Urine culture within 72 hours showing a microorganism resistant to one of the study regimens
7. Known allergy or hypersensitivity to pivmecillinam, penicillins, cephalosporins, aminoglycosides or excipients
8. Pregnancy or breastfeeding
9. Inability to ingest oral medication
10. Known myasthenia gravis
11. Acute mononucleosis or porphyria
12. Pre-existing complicated urogenital conditions
13. Current or earlier treatment with cisplatin and/or carboplatin
14. Descent from the Faroe Islands without prior negative screening for Carnitine Transporter Deficiency (CTD)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 10

1. 30/90/365-day mortality
2. Microbiological cure on Day 3
3. Time to oral-only antibiotic therapy
4. Length of hospital stay
5. Antibiotic treatment duration (combined iv and oral)
6. Nephrotoxicity within 30 days
7. Proportion of treatment-related serious adverse reactions (SAE) and suspected unexpected serious adverse reactions (SUSAR)
8. Secondary infections (C. difficile or genital/oral Candida within 30 days of enrollment)
9. Hospital readmission within 90 days due to UTI
10. Post-discharge antibiotic prescription redemption within 90 days for UTI associated antibiotics.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

TRI-AB

Public contact point

Organisation

Odense University Hospital

Contact name

TRI-AB

Third parties 1

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications