Infection, Bacterial, Kidney Stone, Renal Stone
Conditions
Brief summary
This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.
Detailed description
NGS will be performed on voided urine collected as routine care approximately 30 days prior to surgery. Results will be presented to Infectious Disease pharmacist within 48-72 hours to help select the most appropriate antibiotics, and independently as part of routine care, surgeons will choose the antibiotic that they would use in each case, while the Infectious Disease pharmacists would select their optimum choice. Approximately 220 subjects will be randomly assigned in a 1:1 ratio to receive either NGS antibiotic recommendation or standard of care (SOC) prophylaxis prescribed treatment. Subjects assigned to standard of care will have urine cultures sent for analysis, and the physician will choose antibiotics based on results as per usual practice. Subjects assigned to the NGS group, in addition to routine urine culture results, will have NGS urine culture results sent to an investigational drrug (ID) pharmacist, and recommendations will be shared with the physician to determine the antibiotic selection. The physician will ultimately decide the appropriate antibiotics to prescribe. Approximately 7-14 days after surgery, the research staff will conduct a telephone call to ask about any post-operative infections, complications, and any additional antibiotics that were prescribed.
Interventions
OTHERNGS + Antibiotic Recommendation
NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
PROCEDUREStandard of Care treatment
Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
Sponsors
Microgen LLC
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy or any other transurethral procedure * Age 18 or older * Able to give informed consent
Exclusion criteria
* Unwilling or unable to provide informed consent * Age \< 18 * Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Infection Post Surgery | One to two weeks after surgery (approximately 100 days from baseline) | Number of participants that develop post surgical infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants for Whom Additional Antibiotics Were Selected | Within 30 days of urine culture and date of surgery (approximately 100 days from baseline) | The number of participants who required their antibiotic treatment to be augmented (additional antibiotic given) or escalated (broader-spectrum antibiotic chosen). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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. | 86 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subjects who did not complete were either screened positive for infection or non compliant | 69 | 35 |
Baseline characteristics
| Characteristic | Total | Control Group | Intervention Group (NGS + Antibiotic Recommendation) |
|---|---|---|---|
| Age, Continuous | 52 years | 52 years | 50 years |
| Body Mass Index (BMI) | 32 Kg/m^2 | 32 Kg/m^2 | 31 Kg/m^2 |
| Diabetes diagnosis | 34 Participants | 20 Participants | 14 Participants |
| Race/Ethnicity, Customized Black | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic | 56 participants | 38 participants | 18 participants |
| Race/Ethnicity, Customized Other | 7 participants | 5 participants | 2 participants |
| Race/Ethnicity, Customized White | 70 participants | 43 participants | 27 participants |
| Region of Enrollment United States | 136 participants | 86 participants | 50 participants |
| Sex/Gender, Customized Female | 56 Participants | 40 Participants | 16 Participants |
| Sex/Gender, Customized Male | 76 Participants | 44 Participants | 32 Participants |
| Sex/Gender, Customized Non-binary | 4 Participants | 2 Participants | 2 Participants |
| Surgery type Nephrolithotomy (PCNL) | 4 Participants | 2 Participants | 2 Participants |
| Surgery type Other (ESWL or cystolithopaxy) | 7 Participants | 7 Participants | 0 Participants |
| Surgery type Percutaneous | 17 Participants | 14 Participants | 3 Participants |
| Surgery type Ureteroscopy (URS) | 115 Participants | 70 Participants | 45 Participants |
| Ureteral stent in place | 31 Participants | 18 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 86 |
| other Total, other adverse events | 0 / 50 | 1 / 86 |
| serious Total, serious adverse events | 0 / 50 | 0 / 86 |
Outcome results
Primary
Incidence of Infection Post Surgery
Number of participants that develop post surgical infection
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group (NGS + Antibiotic Recommendation) | Incidence of Infection Post Surgery | 0 participants |
| Control Group | Incidence of Infection Post Surgery | 7 participants |
Secondary
Number of Participants for Whom Additional Antibiotics Were Selected
The number of participants who required their antibiotic treatment to be augmented (additional antibiotic given) or escalated (broader-spectrum antibiotic chosen).
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group (NGS + Antibiotic Recommendation) | Number of Participants for Whom Additional Antibiotics Were Selected | 3 Participants |
| Control Group | Number of Participants for Whom Additional Antibiotics Were Selected | 0 Participants |