IMPACT – the introduction of mycotic prophylaxis at cystectomy trial.

2023-506226-36-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 23 Jun 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 5 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 420
Countries 1
Sites 5

Fungal infection

To explore whether treatment with prophylactic antimycotic medicine can reduce complications after radical cystectomy compared to placebo.

Key facts

Sponsor
Rigshospitalet
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
23 Jun 2024 → ongoing
Decision date (initial)
2024-02-16
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

To explore whether treatment with prophylactic antimycotic medicine can reduce complications after radical cystectomy compared to placebo.

Conditions and MedDRA coding

Fungal infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Patients > 18 years
  2. Willingness to participate in the study and the ability to understand and sign an informed consent in Danish
  3. Indication for performing cystectomy
  4. The urinary diversion is limited to the ileal conduit

Exclusion criteria 2

  1. Patients with contraindications to Fluconazole. This includes allergies and treatment with non-pausable medication that in combination is contraindicated
  2. Patients in active treatment for mycotic infections

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Postoperative complications measured by Clavien Dindo III-V classification score

Secondary endpoints 8

  1. Days Alive and Out of Hospital measured within the 90th postoperative day
  2. Time to gastrointestinal function (first bowel movement) postoperatively
  3. Reduction in percentage of patients who require placement of nasogastric tube postoperatively
  4. Quality of Life measured by questionnaires (EORTC QLQ-C30 and QLQ-BLM30) at day 0 and day 90
  5. Length of stay for index admission
  6. Re-admission within 30 and 90 days
  7. Microbiome resistance development in the urinary tract
  8. Urinary tract infections requiring treatment

Investigational products

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

Test 1

Fluconazole Kabi 2mg/ml solution for infusion

PRD10277156 · Product

Active substance
Fluconazole
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
400 mg milligram(s)
Max total dose
12000 mg milligram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
J02AC01 — FLUCONAZOLE
Marketing authorisation
MA1123/00802
MA holder
FRESENIUS KABI ITALIA S.R.L.
MA country
Malta
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Natriumklorid ”B. Braun”

PRD563912 · Product

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
6 mmol/kg millimole(s)/kilogram
Max total dose
10000 ml millilitre(s)
Max treatment duration
1 Month(s)
Authorisation status
Authorised
ATC code
B05BB01 — ELECTROLYTES
Marketing authorisation
13341
MA holder
B.BRAUN MELSUNGEN AG
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

94 Total trials 54 Recruiting 24 Ended
Academic / Non-commercial
Sponsor organisation
Rigshospitalet
Address
Blegdamsvej 9
City
Copenhagen Oe
Postcode
2100
Country
Denmark

Scientific contact point

Organisation
Rigshospitalet
Contact name
Urologisk Forskningsenhed

Public contact point

Organisation
Rigshospitalet
Contact name
Urologisk Forskningsenhed

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 5 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 420 5
Rest of world — 0 —

Investigational sites

Denmark

5 sites · Ongoing, recruiting
Aarhus Universitet
Department of Urology, Palle Juul-Jensens Boulevard 82, 8200, Aarhus N
Rigshospitalet
Department of Urology, Blegdamsvej 9, 2100, Copenhagen Oe
Herlev Hospital
Department of Urology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Aalborg University Hospital
Department of Urology, Reberbansgade 15, 9000, Aalborg
Odense University Hospital
Department of Urology, J B Winsloews Vej 4, 5000, Odense C

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2024-06-23 2024-06-24

Results and documents

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

Documents 11 files

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

TypeTitleVersion
Protocol (for publication) Trial Protokol 1.5
Protocol (for publication) Trial Protokol_TC 1.5
Recruitment arrangements (for publication) Recruitment arrangement 1.1
Recruitment arrangements (for publication) Recruitment arrangements - track changes 1
Subject information and informed consent form (for publication) Deltagerinformation 1.4
Subject information and informed consent form (for publication) Deltagerinformation_TC 1.4
Subject information and informed consent form (for publication) Participant information 1.1
Subject information and informed consent form (for publication) Participant information_TC 1.1
Summary of Product Characteristics (SmPC) (for publication) Produktresume Fluconazol 1
Synopsis of the protocol (for publication) Dansk resume 1.3
Synopsis of the protocol (for publication) Dansk resume_TC 1.3

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-11-10 Denmark Acceptable
2024-01-23
 2024-02-16
2 SUBSTANTIAL MODIFICATION SM-1 2024-04-12 Denmark Acceptable
2024-06-14
 2024-06-14
3 SUBSTANTIAL MODIFICATION SM-4 2025-02-25 Denmark Acceptable 2025-04-07
4 SUBSTANTIAL MODIFICATION SM-7 2025-08-05 Denmark Acceptable 2025-09-16
5 SUBSTANTIAL MODIFICATION SM-9 2025-08-18 Denmark Acceptable
2025-09-04
 2025-09-04
6 NON SUBSTANTIAL MODIFICATION NSM-1 2026-03-24 Denmark Acceptable
2025-09-04
 2026-03-24
7 NON SUBSTANTIAL MODIFICATION NSM-2 2026-05-19 Denmark Acceptable
2025-09-04
 2026-05-19

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