Ureteral ObstructionNCT06801405
Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction
An observational study of Ureteral Obstruction and Neoplasms, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ureteral Obstruction, Neoplasms, Acute Kidney Injury
- What is being tested?
- antibiotic prophylaxis
- How many people
- 320 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2021to 10 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated for cancer who required percutaneous nephrostomies
Who may be able to join
- Patients treated for cancer who required percutaneous nephrostomies
Who cannot join
- Patients and/or procedures if percutaneous nephrostomy was used to perform other procedures;
- Patients and/or procedures if percutaneous nephrostomy was used to treat clinical conditions other than malignant ureteral obstruction
- Patients and/or procedures if percutaneous nephrostomy was used to clear the urinary tract of non-malignant causes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction. A Retrospective Cohort Study
This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract infection, compared to not taking antibiotic prophylaxis.
Read the detailed description
The medical records of cancer patients who underwent percutaneous nephrostomy between January 2013 and July 2020 were reviewed. Procedures were excluded if the nephrostomy was used for other procedures (e.g. double-J passage) or for non-malignant urinary tract obstruction (e.g. kidney stones). The association between antibiotic prophylaxis and UTI was assessed using association tests such as Pearson's chi-squared or Fisher's exact test. A significant level of 5% was adopted.
Definitions:
Urinary tract infection - occurs when there are signs and symptoms consistent with a local infection (fever, chills, dysuria, lower back pain, and costovertebral angle tenderness), such as cystitis (bladder or lower UTI) or pyelonephritis (kidney or upper UTI), combined with a positive urine culture (more than 104 colony-forming units of microorganisms per millilitre of urine with a catheter present or more than 105 colony-forming units of microorganisms per millilitre of urine without a catheter present).
UTI related to percutaneous nephrostomy procedure - occurs until seven days after the percutaneous nephrostomy procedure, both for first placement and/or catheter replacement.
UTI related to the nephrostomy catheter - occurs at another time, usually within 90 days of the procedure, in the presence of the nephrostomy catheter, and in the absence of another focus that would justify the infection.
Antibiotic prophylaxis was administered before percutaneous nephrostomy. If there was no record of antibiotics in the cost centre of the institution's database, it was considered that antibiotic prophylaxis was not given.
For the first percutaneous nephrostomy catheter placement, antibiotic prophylaxis was given empirically.
For catheter replacement, antibiotic prophylaxis was both empirical and targeted, based on the result of a pre-procedure urine culture to guide the antibiotic choice.
Percutaneous nephrostomies (first placement and/or catheter replacement) were excluded from analysis if patients were treated for UTI up to 7 days before or during the procedure. However, they were included in analysis outside the period of antibiotic prophylaxis for future UTIs.
- Conditions
- Ureteral Obstruction, Neoplasms, Acute Kidney Injury, Nephrostomy; Complications, Antibiotic Prophylaxis, Urinary Tract Infections
- Being tested
- antibiotic prophylaxis
- Keywords
- antibiotic prophylaxis, percutaneous nephrostomy, urinary tract infections, cancer patients
- Medical subject headings
- Ureteral Obstruction, Neoplasms, Acute Kidney Injury, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic prophylaxisDrug
Antibiotic prophylaxis before percutaneous nephrostomy
| Study group | Role | What they receive |
|---|---|---|
| No antibiotic prophylaxis (NAP) - Group | No antibiotic prophylaxis before percutaneous nephrostomy | |
| Antibiotic prophylaxis (AP) - Group | With antibiotic prophylaxis before percutaneous nephrostomy Receives: Drug: antibiotic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Tract Infection After Percutaneous Nephrostomy Procedure
Proportion of urinary tract infection after each percutaneous nephrostomy
Measured: Up to 7 days after percutaneous nephrostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start2 Apr 2021
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureteral ObstructionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeferson Rodrigo Zanon, Barretos Cancer Hospital
- Investigators
- Ricardo RD Reis, Study chair, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801405
- Sponsor's protocol ID
- 44395921.4.0000.5437
- Status last verified
- May 2026
- First submitted
- 18 Jan 2025
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in a peer-reviewed journal and release of data upon plausible justification
Publications
Zanon JR, Santos TM, Durante H, Hirai WY, Mimica MJ, Fregnani JHTG, Dos Reis R. Antibiotic prophylaxis in percutaneous nephrostomy placements and replacements for malignant urinary tract obstruction. Retrospective cohort study with systematic review and meta-analysis. Front Radiol. 2026 May 19;6:1787168. doi: 10.3389/fradi.2026.1787168. eCollection 2026.
PubMed 42238679
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction. A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06801405
- Acronym / sponsor ID
- 44395921.4.0000.5437
- Conditions
- Ureteral Obstruction, Neoplasms, Acute Kidney Injury, Nephrostomy; Complications, Antibiotic Prophylaxis, Urinary Tract Infections
- Keywords
- antibiotic prophylaxis, percutaneous nephrostomy, urinary tract infections, cancer patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract infection, compared to not taking antibiotic prophylaxis.
Detailed description
The medical records of cancer patients who underwent percutaneous nephrostomy between January 2013 and July 2020 were reviewed. Procedures were excluded if the nephrostomy was used for other procedures (e.g. double-J passage) or for non-malignant urinary tract obstruction (e.g. kidney stones). The association between antibiotic prophylaxis and UTI was assessed using association tests such as Pearson's chi-squared or Fisher's exact test. A significant level of 5% was adopted.
Definitions:
Urinary tract infection - occurs when there are signs and symptoms consistent with a local infection (fever, chills, dysuria, lower back pain, and costovertebral angle tenderness), such as cystitis (bladder or lower UTI) or pyelonephritis (kidney or upper UTI), combined with a positive urine culture (more than 104 colony-forming units of microorganisms per millilitre of urine with a catheter present or more than 105 colony-forming units of microorganisms per millilitre of urine without a catheter present).
UTI related to percutaneous nephrostomy procedure - occurs until seven days after the percutaneous nephrostomy procedure, both for first placement and/or catheter replacement.
UTI related to the nephrostomy catheter - occurs at another time, usually within 90 days of the procedure, in the presence of the nephrostomy catheter, and in the absence of another focus that would justify the infection.
Antibiotic prophylaxis was administered before percutaneous nephrostomy. If there was no record of antibiotics in the cost centre of the institution's database, it was considered that antibiotic prophylaxis was not given.
For the first percutaneous nephrostomy catheter placement, antibiotic prophylaxis was given empirically.
For catheter replacement, antibiotic prophylaxis was both empirical and targeted, based on the result of a pre-procedure urine culture to guide the antibiotic choice.
Percutaneous nephrostomies (first placement and/or catheter replacement) were excluded from analysis if patients were treated for UTI up to 7 days before or during the procedure. However, they were included in analysis outside the period of antibiotic prophylaxis for future UTIs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No antibiotic prophylaxis (NAP) - Group | – | –No antibiotic prophylaxis before percutaneous nephrostomy |
| Antibiotic prophylaxis (AP) - Group | – | Drug: antibiotic prophylaxisWith antibiotic prophylaxis before percutaneous nephrostomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated for cancer who required percutaneous nephrostomies
Key inclusion criteria (1 listed)
- Patients treated for cancer who required percutaneous nephrostomies
Key exclusion criteria (3 listed)
- Patients and/or procedures if percutaneous nephrostomy was used to perform other procedures;
- Patients and/or procedures if percutaneous nephrostomy was used to treat clinical conditions other than malignant ureteral obstruction
- Patients and/or procedures if percutaneous nephrostomy was used to clear the urinary tract of non-malignant causes
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 |
|---|---|---|
| antibiotic prophylaxisAntibiotic prophylaxis before percutaneous nephrostomy | Drug | Antibiotic prophylaxis (AP) - Group |
Primary outcome
Urinary Tract Infection After Percutaneous Nephrostomy Procedure
Time frame: Up to 7 days after percutaneous nephrostomy
Proportion of urinary tract infection after each percutaneous nephrostomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42238679Zanon JR, Santos TM, Durante H, Hirai WY, Mimica MJ, Fregnani JHTG, Dos Reis R. Antibiotic prophylaxis in percutaneous nephrostomy placements and replacements for malignant urinary tract obstruction. Retrospective cohort study with systematic review and meta-analysis. Front Radiol. 2026 May 19;6:1787168. doi: 10.3389/fradi.2026.1787168. eCollection 2026.
- Individual participant dataSharing planned: Yes. Publication in a peer-reviewed journal and release of data upon plausible justification
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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. This study is not recruiting at the moment.
Ricardo RD Reis study chair
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Obstruction and Neoplasms, run by Barretos Cancer Hospital at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 19 May 2026. 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 Brazil. 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. 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?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Tract Infection After Percutaneous Nephrostomy Procedure (time frame: Up to 7 days after percutaneous nephrostomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06801405, which also lists 1 linked publication.
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 19 May 2026.