Trial Outcomes & Findings for Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy (NCT NCT02579161)

Results Overview

Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

98 participants

Primary outcome timeframe

0-30 days post-operatively

Results posted on

2023-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Antibiotics for a 24 Hour Period Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones	Continued Antibiotics Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones
Overall Study STARTED	49	49
Overall Study COMPLETED	49	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antibiotics for a 24 Hour Period n=49 Participants Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones	Continued Antibiotics n=49 Participants Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=49 Participants	0 Participants n=49 Participants	0 Participants n=98 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=49 Participants	31 Participants n=49 Participants	68 Participants n=98 Participants
Age, Categorical >=65 years	12 Participants n=49 Participants	18 Participants n=49 Participants	30 Participants n=98 Participants
Age, Continuous	57.1 years STANDARD_DEVIATION 11.3 • n=49 Participants	59.7 years STANDARD_DEVIATION 11.9 • n=49 Participants	58.9 years STANDARD_DEVIATION 11.5 • n=98 Participants
Sex: Female, Male Female	13 Participants n=49 Participants	13 Participants n=49 Participants	26 Participants n=98 Participants
Sex: Female, Male Male	36 Participants n=49 Participants	36 Participants n=49 Participants	72 Participants n=98 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	49 participants n=49 Participants	49 participants n=49 Participants	98 participants n=98 Participants

PRIMARY outcome

Timeframe: 0-30 days post-operatively

Population: Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure while those in the control arm received antibiotics until external catheters were removed based on surgeon preference

Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response.

Outcome measures

Outcome measures
Measure	Antibiotics for a 24 Hour Period n=49 Participants Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones	Continued Antibiotics n=49 Participants Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones
Number of Participants With Infectious Complications Fever	6 Participants	7 Participants
Number of Participants With Infectious Complications SIRS	6 Participants	8 Participants
Number of Participants With Infectious Complications Bacteriuria	1 Participants	2 Participants
Number of Participants With Infectious Complications Bacteremia	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 0-30 days post operatively

Length of Hospital Stay After Surgery (days)

Outcome measures

Outcome measures
Measure	Antibiotics for a 24 Hour Period n=49 Participants Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones	Continued Antibiotics n=49 Participants Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones
Length of Stay (Days)	1.7 Days Standard Deviation 0.8	1.5 Days Standard Deviation 1.9

SECONDARY outcome

Timeframe: 0 to 30 days after surgery

Overall complication rates are reported based on Clavien-Dindo scale. The numbers reported are recorded Clavien complications. There is only one Clavien complication per patient as such a recorded number indicates one complication of this classification and also one patient with this complication. For example, if a Clavien III is recorded, it is indicating that one patient in that study group had one Clavien III complication. Grade I are any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention. Grade II complications require drug treatments other than those allowed for Grade I complications; Grade III complications require surgical, endoscopic or radiological intervention either IIIa, not under general anesthesia or IIIb, under general anesthesia. Grade IV are Life-threatening complications. Grade V are most severe and result in death of the patient.

Outcome measures

Outcome measures
Measure	Antibiotics for a 24 Hour Period n=49 Participants Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones	Continued Antibiotics n=49 Participants Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones
Number of Participants With Associated Clavien Grade of Adverse Event Grade II	2 Participants	5 Participants
Number of Participants With Associated Clavien Grade of Adverse Event Grade I	4 Participants	3 Participants
Number of Participants With Associated Clavien Grade of Adverse Event Grade IIIA	3 Participants	2 Participants
Number of Participants With Associated Clavien Grade of Adverse Event Grade IIIB	1 Participants	2 Participants

Adverse Events

Antibiotics for a 24 Hour Period

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Continued Antibiotics

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Antibiotics for a 24 Hour Period n=49 participants at risk Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones	Continued Antibiotics n=49 participants at risk Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones
Surgical and medical procedures Hemothorax/Pneumothorax	2.0% 1/49 • Number of events 1 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.	2.0% 1/49 • Number of events 1 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.
Renal and urinary disorders Fevers with Hydronephrosis	0.00% 0/49 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.	2.0% 1/49 • Number of events 1 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.

Other adverse events

Other adverse events
Measure	Antibiotics for a 24 Hour Period n=49 participants at risk Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones	Continued Antibiotics n=49 participants at risk Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication aminoglycoside metronidazole Clindamycin aminoglycoside/ sulbactam: If allergies to above medicines Fluoroquinolones
Blood and lymphatic system disorders fevers post operative	4.1% 2/49 • Number of events 2 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.	10.2% 5/49 • Number of events 5 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.
Renal and urinary disorders Post operative urinary retention	6.1% 3/49 • Number of events 3 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.	2.0% 1/49 • Number of events 1 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.
General disorders Post operative pain	2.0% 1/49 • Number of events 1 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.	2.0% 1/49 • Number of events 1 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.
Surgical and medical procedures Post operative anemia requiring transfusion	0.00% 0/49 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.	2.0% 1/49 • Number of events 1 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.
Surgical and medical procedures Post-operative embolization	6.1% 3/49 • Number of events 3 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.	4.1% 2/49 • Number of events 2 • All adverse events occurring within the first 30 post-operative days were recorded for each patient. The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.

Additional Information

Dr. Zeph Okeke

Northwell Health

Phone: 516-734-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place