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Clinical Trials/NCT03962920
NCT03962920
Recruiting
Not Applicable

Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Zealand University Hospital1 site in 1 country28 target enrollmentMay 1, 2020
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ConditionsMicrobial Disease
InterventionsTigecycline 50 MGPlacebo
DrugsTigecycline 50 MG

Overview

Phase
Not Applicable
Intervention
Tigecycline 50 MG
Conditions
Microbial Disease
Sponsor
Zealand University Hospital
Enrollment
28
Locations
1
Primary Endpoint
recurrence rate after surgical treatment of tumour
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
May 1, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Biopsy verified diagnosis of urological cancer, localized disease

Exclusion Criteria

  • •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

Arms & Interventions

Surgical treatment + antibiotics

Use antibiotic

Intervention: Tigecycline 50 MG

surgical treatment + placebo

Use placebo

Intervention: Placebo

Outcomes

Primary Outcomes

recurrence rate after surgical treatment of tumour

Time Frame: 5 years after treatment

recurrence rate after surgical treatment of tumour

Study Sites (1)

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