Microbial DiseaseNCT03962920
Personalized Treatment of Urogenital Cancers Depends on the Microbiome
A study testing Tigecycline 50 MG in people with Microbial Disease, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Microbial Disease
- What is being tested?
- Tigecycline 50 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2020to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy verified diagnosis of urological cancer, localized disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Roskilde, 4000
Nessn H. Azawi, M.D., 004526393034, nesa@regionsjaelland.dk
Nessn Azawi, M.D.
About this study
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.
- Conditions
- Microbial Disease
- Being tested
- Tigecycline 50 MG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tigecycline 50 MGDrug
Also called Tigecycline
Local instillation of drug directly to the tumour tissue
PlaceboOther
Also called Sterile water
Local instillation of sterile water directly to the tumour tissue
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment + antibiotics | Active comparator | Use antibiotic Receives: Drug: Tigecycline 50 MG |
| surgical treatment + placebo | Placebo comparator | Use placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate after surgical treatment of tumour
recurrence rate after surgical treatment of tumour
Measured: 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 May 2020
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial DiseaseStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962920
- Sponsor's protocol ID
- ZUHURO
- Status last verified
- Jan 2024
- First submitted
- 23 May 2019
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Treatment of Urogenital Cancers Depends on the Microbiome
- ClinicalTrials.gov ID
- NCT03962920
- Acronym / sponsor ID
- ZUHURO
- Conditions
- Microbial Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment + antibiotics | Active comparator | Drug: Tigecycline 50 MGUse antibiotic |
| surgical treatment + placebo | Placebo comparator | Other: PlaceboUse placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Biopsy verified diagnosis of urological cancer, localized disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tigecycline 50 MGAlso: TigecyclineLocal instillation of drug directly to the tumour tissue | Drug | Surgical treatment + antibiotics |
| PlaceboAlso: Sterile waterLocal instillation of sterile water directly to the tumour tissue | Other | surgical treatment + placebo |
Primary outcome
recurrence rate after surgical treatment of tumour
Time frame: 5 years after treatment
recurrence rate after surgical treatment of tumour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tigecycline 50 MG in people with Microbial Disease, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate after surgical treatment of tumour (time frame: 5 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.