Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction

May 17, 2026 updated by: Jeferson Rodrigo Zanon, Barretos Cancer Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Jales, São Paulo, Brazil, 15706-396
        • Jales Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated for cancer who required percutaneous nephrostomies

Description

Inclusion Criteria:

  • Patients treated for cancer who required percutaneous nephrostomies

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No antibiotic prophylaxis (NAP) - Group
No antibiotic prophylaxis before percutaneous nephrostomy
Antibiotic prophylaxis (AP) - Group
With antibiotic prophylaxis before percutaneous nephrostomy
Drug: antibiotic prophylaxis
Antibiotic prophylaxis before percutaneous nephrostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 7 days after percutaneous nephrostomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Investigators

  • Study Chair: Ricardo RD Reis, Barretos Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2021

Primary Completion (Actual)

October 10, 2024

Study Completion (Actual)

October 10, 2024

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 44395921.4.0000.5437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication in a peer-reviewed journal and release of data upon plausible justification

IPD Sharing Time Frame

For an indefinite period

IPD Sharing Access Criteria

Justification sent by e-mail

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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