Trial Outcomes & Findings for Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction (NCT NCT06801405)

Results Overview

Proportion of urinary tract infection after each percutaneous nephrostomy

Recruitment status

COMPLETED

Target enrollment

320 participants

Primary outcome timeframe

Up to 7 days after percutaneous nephrostomy

Results posted on

2026-05-19

Participant Flow

Data were collected on age, sex, skin colour, number of percutaneous nephrostomies performed, including first placements and catheter replacements. The time spent ill and using the nephrostomy catheter was calculated.

As the same participant can undergo more than one percutaneous nephrostomy procedure, be it placement or replacement, and the aim of the study is to assess the rate of urinary tract infection after percutaneous nephrostomy, this becomes the sampling unit and not the participant. Therefore, the number of participants is 320 and the number of procedures studied is 734, of which 214 (29.2%) were excluded from the analysis due to prior antibiotic use.

Unit of analysis: Percutaneous nephrostomy procedure

Participant milestones

Participant milestones
Measure	No Antibiotic Prophylaxis (NAP) - Group No antibiotic prophylaxis before percutaneous nephrostomy	Antibiotic Prophylaxis (AP) - Group With antibiotic prophylaxis before percutaneous nephrostomy
Overall Study STARTED	66 133	153 387
Overall Study COMPLETED	66 133	153 387
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Antibiotic Prophylaxis (NAP) - Group n=66 Participants No antibiotic prophylaxis before percutaneous nephrostomy	Antibiotic Prophylaxis (AP) - Group n=153 Participants With antibiotic prophylaxis before percutaneous nephrostomy	Total n=219 Participants Total of all reporting groups
Age, Continuous	54.37 year-old n=30 Participants	60.27 year-old n=30 Participants	59.04 year-old n=60 Participants
Sex: Female, Male Female	46 Participants n=30 Participants	87 Participants n=30 Participants	133 Participants n=60 Participants
Sex: Female, Male Male	20 Participants n=30 Participants	66 Participants n=30 Participants	86 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=30 Participants	103 Participants n=30 Participants	145 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	24 Participants n=30 Participants	50 Participants n=30 Participants	74 Participants n=60 Participants

PRIMARY outcome

Timeframe: Up to 7 days after percutaneous nephrostomy

Population: The sampling unit for the analyses was the percutaneous nephrostomy procedure, not the patient, since the same patient may have undergone more than one percutaneous nephrostomy procedure, especially for catheter replacement, during cancer treatment.

Proportion of urinary tract infection after each percutaneous nephrostomy

Outcome measures

Outcome measures
Measure	No Antibiotic Prophylaxis (NAP) - Group n=133 Percutaneous nephrostomy procedure No antibiotic prophylaxis before percutaneous nephrostomy	Antibiotic Prophylaxis (AP) - Group n=387 Percutaneous nephrostomy procedure With antibiotic prophylaxis before percutaneous nephrostomy
Urinary Tract Infection After Percutaneous Nephrostomy Procedure	5 Percutaneous nephrostomy procedure	10 Percutaneous nephrostomy procedure

Adverse Events

No Antibiotic Prophylaxis (NAP) - Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 53 deaths

Antibiotic Prophylaxis (AP) - Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 127 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeferson Rodrigo Zanon

Barretos Cancer Hospital

Phone: +551736243900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place