Trial Outcomes & Findings for Antibiotic Selection Using Next Generation Sequencing vs Urine Culture (NCT NCT04404855)
NCT ID: NCT04404855
Last Updated: 2024-03-12
Results Overview
Number of participants that develop post surgical infection
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
One to two weeks after surgery (approximately 100 days from baseline)
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Intervention Group (NGS + Antibiotic Recommendation)
Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
NGS + Antibiotic Recommendation: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
|
Control Group
NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
121
|
|
Overall Study
COMPLETED
|
50
|
86
|
|
Overall Study
NOT COMPLETED
|
69
|
35
|
Reasons for withdrawal
| Measure |
Intervention Group (NGS + Antibiotic Recommendation)
Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
NGS + Antibiotic Recommendation: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
|
Control Group
NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
|
|---|---|---|
|
Overall Study
Subjects who did not complete were either screened positive for infection or non compliant
|
69
|
35
|
Baseline Characteristics
Antibiotic Selection Using Next Generation Sequencing vs Urine Culture
Baseline characteristics by cohort
| Measure |
Intervention Group (NGS + Antibiotic Recommendation)
n=50 Participants
Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
NGS + Antibiotic Recommendation: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
|
Control Group
n=86 Participants
NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
52 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
32 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
16 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
18 participants
n=5 Participants
|
38 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
27 participants
n=5 Participants
|
43 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
86 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Diabetes diagnosis
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ureteral stent in place
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Surgery type
Ureteroscopy (URS)
|
45 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Surgery type
Percutaneous
|
3 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Surgery type
Nephrolithotomy (PCNL)
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Surgery type
Other (ESWL or cystolithopaxy)
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31 Kg/m^2
n=5 Participants
|
32 Kg/m^2
n=7 Participants
|
32 Kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: One to two weeks after surgery (approximately 100 days from baseline)Population: Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy
Number of participants that develop post surgical infection
Outcome measures
| Measure |
Intervention Group (NGS + Antibiotic Recommendation)
n=50 Participants
Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
NGS + Antibiotic Recommendation: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
|
Control Group
n=86 Participants
NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
|
|---|---|---|
|
Incidence of Infection Post Surgery
|
0 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Within 30 days of urine culture and date of surgery (approximately 100 days from baseline)Population: Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy
The number of participants who required their antibiotic treatment to be augmented (additional antibiotic given) or escalated (broader-spectrum antibiotic chosen).
Outcome measures
| Measure |
Intervention Group (NGS + Antibiotic Recommendation)
n=50 Participants
Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
NGS + Antibiotic Recommendation: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
|
Control Group
n=86 Participants
NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
|
|---|---|---|
|
Number of Participants for Whom Additional Antibiotics Were Selected
|
3 Participants
|
0 Participants
|
Adverse Events
Intervention Group (NGS + Antibiotic Recommendation)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group (NGS + Antibiotic Recommendation)
n=50 participants at risk
Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
NGS + Antibiotic Recommendation: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
|
Control Group
n=86 participants at risk
NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
Standard of Care treatment: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/50 • Adverse events are collected from Baseline (day 1) up to 90 days from enrollment
|
1.2%
1/86 • Number of events 1 • Adverse events are collected from Baseline (day 1) up to 90 days from enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place