NCT03962920

Brief Summary

This is a randomized controlled trial where patients undergoing surgical treatment for urogenital cancers will be randomized in a two arms study: surgical treatment + antibiotics OR surgical treatment + placebo.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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 Progress86%
May 2020May 2027

First Submitted

Initial submission to the registry

May 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

5 years

First QC Date

May 23, 2019

Last Update Submit

January 28, 2024

Conditions

Microbial Disease

Outcome Measures

Primary Outcomes (1)

  • recurrence rate after surgical treatment of tumour

    recurrence rate after surgical treatment of tumour

    5 years after treatment

Study Arms (2)

Surgical treatment + antibiotics

ACTIVE COMPARATOR

Use antibiotic

Drug: Tigecycline 50 MG

surgical treatment + placebo

PLACEBO COMPARATOR

Use placebo

Other: Placebo

Interventions

Tigecycline 50 MGDRUG

Local instillation of drug directly to the tumour tissue

Also known as: Tigecycline
Surgical treatment + antibiotics
PlaceboOTHER

Local instillation of sterile water directly to the tumour tissue

Also known as: Sterile water
surgical treatment + placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy verified diagnosis of urological cancer, localized disease

You may not qualify if:

  • Hospitalization within three months of surgery
  • Antibiotics within three months of surgery
  • Infectious disease, including UTI's within three months of surgery
  • History of cancers of the genitourinary tract
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Interventions

Tigecycline

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 24, 2019

Study Start

May 1, 2020

Primary Completion

May 1, 2025

Study Completion (Estimated)

May 1, 2027

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

DK(1)