Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
248
Countries
1
Sites
5
Bacterial infection
The main objective of the study is to explore whether the use of targeted antibiotic prophylaxis can reduce infection-related readmissions following cystectomy compared to the current regimen given at ureteral stent removal.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 7 Jan 2025 → ongoing
- Decision date (initial)
- 2024-12-10
- 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: Prophylaxis
The main objective of the study is to explore whether the use of targeted antibiotic prophylaxis can reduce infection-related readmissions following cystectomy compared to the current regimen given at ureteral stent removal.
Conditions and MedDRA coding
Bacterial infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age at surgery ≥ 18 years
- Ability to understand and sign an informed consent
- Malignant or benign indication for undergoing cystectomy
- Planned ileal conduit as urinary diversion
Exclusion criteria 2
- Previous severe allergic reaction to antimicrobial treatment
- Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 90-day infection-related hospital readmission rate
Secondary endpoints 6
- Timing of ureteral stent removal and type of antimicrobial prophylaxis administered at ureteral stent removal
- All-cause readmissions within 30 and 90 days after surgery, including main cause, timing, duration, microbiological tests, and antimicrobial treatment
- Postoperative complications within 30 and 90 days of surgery using the Clavien-Dindo classification score
- Days-alive-and-out-of-hospital (DAOH) at POD 30 and 90
- Quality-of-life using the EORTC QLQ-C30 and QLQ-BLM30 questionnaires filled out preoperatively and on POD 90
- Microbiological findings and antimicrobial susceptibility analyses in pre- and postoperative microbiological samples
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
Trimopan, filmovertrukne tabletter
PRD620953 · Product
- Active substance
- Trimethoprim
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01EA01 — TRIMETHOPRIM
- Marketing authorisation
- 09204
- MA holder
- ORION CORPORATION
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10725796 · Product
- Active substance
- Cefuroxime Axetil
- Substance synonyms
- CEFUROXIMAXETIL, CEFUROXIM-AXETIL, CEFUROXIMUM AXETILUM
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DC02 — -
- Marketing authorisation
- 15/0247/13-S
- MA holder
- SANDOZ PHARMACEUTICALS D.D.
- MA country
- Slovakia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Amoxicillin 500 mg film-coated tablets
PRD10348401 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- PL 25298/0390
- MA holder
- BROWN & BURK UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ciprofloxacin 500 mg, film coated tablets
PRD11148900 · Product
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- PL 18374/0004
- MA holder
- WISE PHARMACEUTICALS LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10237593 · Product
- Active substance
- Nitrofurantoin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XE01 — NITROFURANTOIN
- Marketing authorisation
- PL 04569/2078
- MA holder
- GENERICS [UK] LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sulfametoxazol med trimetoprim SAD, tabletter
PRD351283 · Product
- Active substance
- Sulfamethoxazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 6400 mg milligram(s)
- Max total dose
- 6400 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- 16511
- MA holder
- AMGROS I/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10145350 · Product
- Active substance
- Fluconazole
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AC01 — FLUCONAZOLE
- Marketing authorisation
- PL 20416/0760
- MA holder
- CRESCENT PHARMA LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Linezolid Teva 600 mg filmdragerade tabletter
PRD2362021 · Product
- Active substance
- Linezolid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- 49967
- MA holder
- TEVA SWEDEN AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bioclavid 500 mg/125 mg filmdragerade tabletter
PRD727168 · Product
- Active substance
- Amoxicillin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 3500 mg milligram(s)
- Max total dose
- 3500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 14081
- MA holder
- SANDOZ GMBH
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets
PRD7200361 · Product
- Active substance
- Pivmecillinam Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA08 — PIVMECILLINAM
- Marketing authorisation
- PA22650/003/001
- MA holder
- KARO PHARMA AB
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Maja Vejlgaard
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Maja Vejlgaard
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 248 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Odense University Hospital
Department of Urology, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Department of Urology, Blegdamsvej 9, 2100, Copenhagen Oe
Herlev Hospital
Department of Urology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Aarhus University Hospital
Department of Urology, Palle Juul-Jensens Boulevard 99, 8250, Aarhus
Aalborg University Hospital
Department of Urology, Reberbansgade 15, 9000, Aalborg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-01-07 | 2025-01-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Trial protocol | 2.1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Deltagerinformation og samtykke | 2.0 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | Amoxicillin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Amoxicillin clavulanic acid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Cefuroxime | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ciprofloxacin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Fluconazole | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Linezolid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Nitrofurantoin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pivmecillinam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Sulfametoxazole trimethoprim | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Trimethoprim | 1 |
| Synopsis of the protocol (for publication) | Dansk resume | 2.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-13 | Denmark | Acceptable 2024-11-19
|
2024-12-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-18 | Denmark | Acceptable 2026-02-13
|
2026-02-13 |