NCT06709196

Brief Summary

The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis. Participants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently given at Rigshospitalet, Copenhagen or (B) a conventional orally administered antibiotic prophylaxis targeting bacteria found in the urine postoperatively. The investigators' hypothesis is that the targeted prophylactic antibiotic strategy will reduce the number of infection-related readmissions within 90 days of surgery compared to the standardised prophylaxis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for phase_4

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jan 2025Jan 2027

First Submitted

Initial submission to the registry

November 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 7, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 9, 2025

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

November 25, 2024

Last Update Submit

January 8, 2025

Conditions

CystectomyBladder Cancer Requiring CystectomyPostoperative InfectionsAntibiotic ProphylaxisIleal Conduit

Keywords

Targeted antimicrobial prophylaxisInfection-related readmissions

Outcome Measures

Primary Outcomes (1)

  • Infection-related readmission rate

    The rate of readmissions where the main cause of readmission is symptoms of infection.

    90 days after surgery

Secondary Outcomes (7)

  • Postoperative complications

    30 and 90 days after surgery

  • Postoperative readmissions

    30 and 90 days after surgery

  • Days alive and out of hospital

    30 and 90 days after surgery

  • Quality of life

    90 days after surgery

  • Quality of life

    90 days after surgery

  • +2 more secondary outcomes

Study Arms (2)

Targeted antimicrobial prophylaxis

EXPERIMENTAL

The participants in this arm will receive a single-day orally administered targeted antimicrobial prophylaxis on the day of ureteral stent removal based on the microbiological analysis of a postoperative urine culture.

Drug: PivmecillinamDrug: Amoxicillin clavulanic acidDrug: AmoxicillinDrug: CefuroximeDrug: CiprofloxacinDrug: LinezolidDrug: NitrofurantoinDrug: TrimethoprimDrug: Sulfamethoxazole trimethoprimDrug: Fluconazole

Empiric antimicrobial prophylaxis

ACTIVE COMPARATOR

The participants in this arm will receive three doses of orally administered pivmecillinam 400mg morning, noon, and evening on the day of ureteral stent removal.

Drug: Pivmecillinam

Interventions

PivmecillinamDRUG

Orally administered pivmecillinam 400mg

Empiric antimicrobial prophylaxis
Amoxicillin clavulanic acidDRUG

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Targeted antimicrobial prophylaxis
AmoxicillinDRUG

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Targeted antimicrobial prophylaxis
CefuroximeDRUG

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Targeted antimicrobial prophylaxis
CiprofloxacinDRUG

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Targeted antimicrobial prophylaxis
LinezolidDRUG

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Targeted antimicrobial prophylaxis
NitrofurantoinDRUG

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Targeted antimicrobial prophylaxis
TrimethoprimDRUG

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Targeted antimicrobial prophylaxis
Sulfamethoxazole trimethoprimDRUG

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Targeted antimicrobial prophylaxis
FluconazoleDRUG

Orally administered targeted antimicrobial prophylaxis based on a urine culture.

Targeted antimicrobial prophylaxis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous severe allergic reaction to antimicrobial treatment
  • Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Urology, Aalborg University Hospital

Aalborg, 9100, Denmark

NOT YET RECRUITING

Department of Urology, Aarhus University Hospital

Aarhus, 8200, Denmark

NOT YET RECRUITING

Department of Urology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Department of Urology, Herlev and Gentofte Hospital

Herlev, 2730, Denmark

NOT YET RECRUITING

Department of Urology, Odense University Hospital

Odense, 5000, Denmark

NOT YET RECRUITING

Related Publications (1)

  • Vejlgaard M, Stroomberg HV, Ynddal MS, Moser C, Joensen UN, Roder A. Multicentre, open-label, phase IV, randomised trial testing superiority of individualised targeted antibiotic prophylaxis over empiric prophylaxis at ureteral stent removal following cystectomy: study protocol for the REINFORCE trial. Trials. 2025 Jul 28;26(1):258. doi: 10.1186/s13063-025-08981-w.

    PMID: 40722189DERIVED

MeSH Terms

Interventions

Amdinocillin PivoxilAmoxicillin-Potassium Clavulanate CombinationAmoxicillinCefuroximeCiprofloxacinLinezolidNitrofurantoinTrimethoprimTrimethoprim, Sulfamethoxazole Drug CombinationFluconazole

Intervention Hierarchy (Ancestors)

AmdinocillinPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsClavulanic AcidClavulanic AcidsAmpicillinPenicillin GDrug CombinationsPharmaceutical PreparationsCephalosporinsThiazinesFluoroquinolones4-QuinolonesQuinolonesQuinolinesAcetamidesAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingNitrofuransNitro CompoundsFuransPyrimidinesSulfamethoxazoleBenzenesulfonamidesSulfonamidesSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesTriazoles

Study Officials

  • Andreas Røder, Prof, MD, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Vejlgaard

CONTACT

+4535456152maja.vejlgaard.02@regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating investigator, MD

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 29, 2024

Study Start

January 7, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 9, 2025

Record last verified: 2024-12

Locations

DK(5)