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

NCT06801405 | Completed DMC

• 1 other identifier: 44395921.4.0000.5437
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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 infection, compared to not taking antibiotic prophylaxis.

Conditions

Ureteral Obstruction; Neoplasms; Acute Kidney Injury; Nephrostomy; Complications; Antibiotic Prophylaxis; Urinary Tract Infections

Keywords

antibiotic prophylaxis; percutaneous nephrostomy; urinary tract infections; cancer patients

Outcome Measures

Primary Outcomes (1)

• Urinary tract infection rate

  Proportion of urinary tract infection after each percutaneous nephrostomy

  Up to 7 days after percutaneous nephrostomy

Study Arms (2)

No antibiotic prophylaxis (NAP) - Group

No antibiotic prophylaxis before percutaneous nephrostomy

Antibiotic prophylaxis (AP) - Group

With antibiotic prophylaxis before percutaneous nephrostomy

Drug: antibiotic prophylaxis

Interventions

antibiotic prophylaxis DRUG

Antibiotic prophylaxis before percutaneous nephrostomy

Antibiotic prophylaxis (AP) - Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for cancer who required percutaneous nephrostomies

You may qualify if:

• Patients treated for cancer who required percutaneous nephrostomies

You may not qualify if:

• 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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Jales Cancer Hospital

Jales, São Paulo, 15706-396, Brazil

Location

MeSH Terms

Conditions

Ureteral Obstruction; Neoplasms; Acute Kidney Injury; Urinary Tract Infections

Interventions

Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Kidney Diseases; Infections

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Premedication

Study Officials

• Ricardo RD Reis

  Barretos Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 30, 2025
• Study Start: April 2, 2021
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: For an indefinite period
• Access Criteria: Justification sent by e-mail

Locations

BR (1)