A Phase 3 interventional study of cephalosporins and Fluoroquinolones in Kidney Stones, sponsored by Northwell Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Northwell Health · Phase 3, Interventional, and Other
The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
For large renal stone burdens and/or complex stones, Percutaneous Nephrolithotomy (PCNL) has become the mainstay for treatment, replacing open kidney stone surgery since it's introduction in 1976. However, PCNL is not without its complications, specifically infectious. The procedure carries up to 25% incidence of infectious complications with approximately 1% rate of severe sepsis even with completely sterile conditions. Therefore, the use of antibiotics becomes paramount, but to date there are no PNCL specific guidelines for the appropriate duration and class of antibiotics. This fact leaves the practicing urologists to their own subjective experiences to the guide them. In addition, in an age where there are increasing numbers of resistant microbes the judicious use of antibiotics is in even more paramount.
The investigators of this project, purpose a randomized intention to treat prospective study to explore the duration and type of antibiotics in a larger population then previously studied. The investigators hypothesize that there will be no difference in complications between two groups: 1) 24 hours of perioperative antibiotics versus 2) Continued antibiotics until the removal of any external catheters. The investigators will model the antibiotics choices and duration after the 2013 American Urological Association, (AUA) Urologic Surgery Antimicrobial Prophylaxis recommendations, modified by our local antibiogram as necessary. The investigators' objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. Our hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
Antibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone
Looking at the same drugs and doses the variable is the timeframe of the medication
605 studies on the registry are indexed under Kidney Calculi; 164 are open to participants now.
This study's enrollment of 98 is close to the median of 90 across 464 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Northwell Health is the lead sponsor of 473 studies on the registry; 106 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 22 (51%) have results posted.
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Exclusion Criteria:
Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc.
Drug: cephalosporins · Drug: Fluoroquinolones · Drug: Clindamycin · Drug: Ampicillin/Gentamicin
Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc.
Drug: cephalosporins · Drug: Fluoroquinolones · Drug: Clindamycin · Drug: Ampicillin/Gentamicin
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. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed
Also known as: ancef
If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance
Also known as: ciprofloxacin
If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.
Also known as: Lincosamides
Drug pages: Ampicillin · Gentamicins
5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin
Also known as: Penicillinase-sensitive penicillin\Aminoglycoside
Number of Participants With Infectious Complications
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.
Time frame: 0-30 days post-operatively
Length of Stay (Days)
Length of Hospital Stay After Surgery (days)
Time frame: 0-30 days post operatively
Number of Participants With Associated Clavien Grade of Adverse Event
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.
Time frame: 0 to 30 days after surgery
| Milestone | Antibiotics for a 24 Hour Period | Continued Antibiotics |
|---|---|---|
| Started | 49 | 49 |
| Completed | 49 | 49 |
| Not completed | 0 | 0 |
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.
| Participants | Antibiotics for a 24 Hour Period | Continued Antibiotics |
|---|---|---|
| Fever | 6 | 7 |
| SIRS | 6 | 8 |
| Bacteriuria | 1 | 2 |
| Bacteremia | 1 | 1 |
Length of Hospital Stay After Surgery (days)
| Days | Antibiotics for a 24 Hour Period | Continued Antibiotics |
|---|---|---|
| Length of Stay (Days) | 1.7 ± 0.8 | 1.5 ± 1.9 |
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.
| Participants | Antibiotics for a 24 Hour Period | Continued Antibiotics |
|---|---|---|
| Grade I | 4 | 3 |
| Grade II | 2 | 5 |
| Grade IIIA | 3 | 2 |
| Grade IIIB | 1 | 2 |
Collected over All adverse events occurring within the first 30 post-operative days were recorded for each patient.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antibiotics for a 24 Hour Period | 0/49 (0%) | 1/49 (2%) | 9/49 (18.4%) |
| Continued Antibiotics | 0/49 (0%) | 2/49 (4.1%) | 10/49 (20.4%) |
| Event | Antibiotics for a 24 Hour Period | Continued Antibiotics |
|---|---|---|
| Hemothorax/PneumothoraxSurgical and medical procedures | 1/49 | 1/49 |
| Fevers with HydronephrosisRenal and urinary disorders | 0/49 | 1/49 |
| Event | Antibiotics for a 24 Hour Period | Continued Antibiotics |
|---|---|---|
| fevers post operativeBlood and lymphatic system disorders | 2/49 | 5/49 |
| Post operative urinary retentionRenal and urinary disorders | 3/49 | 1/49 |
| Post-operative embolizationSurgical and medical procedures | 3/49 | 2/49 |
| Post operative painGeneral disorders | 1/49 | 1/49 |
| Post operative anemia requiring transfusionSurgical and medical procedures | 0/49 | 1/49 |
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.
| Age, Categorical(Participants) | Antibiotics for a 24 Hour Period | Continued Antibiotics | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 37 | 31 | 68 |
| >=65 years | 12 | 18 | 30 |
| Age, Continuous(years) | Antibiotics for a 24 Hour Period | Continued Antibiotics | Total |
|---|---|---|---|
| Mean | 57.1 ± 11.3 | 59.7 ± 11.9 | 58.9 ± 11.5 |
| Sex: Female, Male(Participants) | Antibiotics for a 24 Hour Period | Continued Antibiotics | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 36 | 36 | 72 |
| Race and Ethnicity Not Collected(Participants) | Antibiotics for a 24 Hour Period | Continued Antibiotics | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Antibiotics for a 24 Hour Period | Continued Antibiotics | Total |
|---|---|---|---|
| United States | 49 | 49 | 98 |
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Studies of the drugs tested here: Cephalosporins · Fluoroquinolones · Clindamycin · Ampicillin · Gentamicins