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Antibiotic Prophylaxis Before Shock Wave Lithotripsy (APPEAL)

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ClinicalTrials.gov Identifier: NCT03692715
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborators:
University of Western Ontario, Canada
Hospital District of Helsinki and Uusimaa
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
King Abdulaziz University
Hospital Sao Luiz
Information provided by (Responsible Party):
Kari Tikkinen, Clinical Urology and Epidemiology Working Group

Brief Summary:
This is a two arm, double blind RCT comparing the use of a single dose ciprofloxacin prior to SWL to saline alone. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.

Condition or disease Intervention/treatment Phase
Ureteral Stones Ureteral Calculi Nephrolithiasis Drug: Ciprofloxacin Drug: Placebo Phase 4

Detailed Description:

This is a two arm, double blind randomized controlled trial (RCT) comparing the use of a single dose ciprofloxacin prior to shock wave lithotripsy (SWL) to placebo. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.

Eligibility criteria include patients older than 18 years presenting for SWL who do not meet one of the pre-defined exclusion criteria (outlined below).

Eligible patients will provide written informed consent. Patients will undergo central randomization, which will be accessed by phone or internet. Un-blinding will occur only once statistical analysis is complete.

Patients will undergo SWL using standard procedures at the participating center. Participants will asked to provide a pre-procedure study questionnaire, a modified International Prostate Symptom Score (IPSS) questionnaire and a urine sample for analysis prior to SWL and follow-up. Follow-up questionnaires and a requisition for urine culture will be provided in a pre-stamped, self-addressed envelope along with instructions to return both culture and questionnaires to their participating center at 7-14 days post-SWL. If the follow-up questionnaire has not been received by post-operative day 10 patients will receive a reminder phone call. A second envelope will be sent containing a requisition for urine culture and follow-up questionnaire when necessary.

Alternatively, if a 2 week follow-up is conducted at the participating site then data-forms can be completed and collected at that time. In the event that a urine culture was not submitted 7 days post-operatively, one can be collected up to 14 days post-op. Additional clinical parameters such as presence of double J, stone characteristics and renal insufficiency will be recorded at the time of SWL by the dedicated research staff at the participating center. Data acquisition and occurrence of outcomes will be monitored continuously with scheduled audits.

Primary and secondary outcomes are outlined below.

The power calculation for this protocol was performed using Stata v.10.1 (StataCorp, College Station, TX). The investigators used the American Urological Association Best Practice Statement on antibiotic prophylaxis to estimate a 60% relative risk reduction with treatment arm. Therefore to achieve a power of 90% with a significance level of p<0.05, 661 patients will need to be recruited in each arm for a total of 1,322 patients. Accounting for 10% loss to follow-up, the total required will be 1454, or approximately 1500 patients. Assuming that 25% of patients screened will either refuse to be randomized or will meet one of the pre-defined exclusion criteria, a minimum of 2000 patients will need to be screened in order to randomize 1500 patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients will undergo central randomization, which will be accessed by phone or internet. Un-blinding will occur only once statistical analysis is complete.
Primary Purpose: Prevention
Official Title: A Multicenter Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection
Estimated Study Start Date : September 27, 2018
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: ciprofloxacin
Single dose oral or intravenous ciprofloxacin prior to shockwave lithotripsy
Drug: Ciprofloxacin
Oral or intravenous ciprofloxacin prior to shockwave lithotripsy.
Other Name: Cipro

Placebo Comparator: Placebo
identical oral placebo if oral cipro was used, or intravenous saline alone in a blinded fashion if IV cipro was used prior to shockwave lithotripsy.
Drug: Placebo
identical oral placebo if oral cipro was used, or intravenous saline alone in a blinded fashion if IV cipro was used prior to shockwave lithotripsy.




Primary Outcome Measures :
  1. Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis [ Time Frame: 7-14 days post-shockwave lithotripsy ]
    The composite outcome with be assessed as a dichotomous variable. The presence of Positive post-SWL urine culture (≥ 10e5 Colony Forming Unit/ ml), with one or more of symptoms of cystitis (defined as new onset burning sensation or pain with voiding, frequency, urgency), or pyelonephritis or urosepsis (hospital admission with fever ≥38.5 C) will be considered as an event.


Secondary Outcome Measures :
  1. Bacteriuria defined as ≥ 100000 Colony Forming Unit/ml [ Time Frame: 7-14 days post-shockwave lithotripsy ]
    Bacteriuria will be assessed as a dichotomous variable with presence of is ≥100000 Colony Forming Unit/ml will be considered as an event

  2. Symptoms of cystitis defined as new onset burning sensation or pain with voiding, frequency, urgency [ Time Frame: 7-14 days post-shockwave lithotripsy ]
    Symptoms of cystitis will be considered as a dichotomous variable with new onset burning sensation or pain with voiding, frequency, urgency will be considered an event

  3. Pyelonephritis or urosepsis defined as Hospital admission with fever ≥38.5 Celsius [ Time Frame: 7-14 days post-shockwave lithotripsy ]
    Pyelonephritis or urosepsis will be assessed as a dichotomous variable with Hospital admission with fever ≥38.5 Celsius will be considered as an event

  4. Change in International Prostate Symptom Score (IPSS) total score (0-35, higher score indicates worse outcome) [ Time Frame: 14 days post-shockwave lithotripsy ]
    Change in total value of IPSS score will be assessed as a continuous variable with a range from 0-35 with higher scores indicating more severe symptoms. This score is calculated by summation of individual component scores (0-5) across 7 domains

  5. Individual components of International Prostate Symptom Score (0-7 per domain, with higher score indicating worse outcome) [ Time Frame: 14 days post-shockwave lithotripsy ]
    Individual IPSS domains will be assessed as continuous variables and include incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Higher scores as considered as more severe symptoms

  6. Pain scale determined on a range of 0-5 with higher score indicating worse outcome [ Time Frame: 14 days post-shockwave lithotripsy ]
    Pain scale will be assessed as a continuous variable. The scale will be elicited by asking In the past week, how often have you had burning or discomfort with urination? Higher score is considered as more severe symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients older than 18 years presenting for SWL who do not meet one of the pre-defined exclusion criteria.

Exclusion Criteria:

  • Pre-SWL urine analysis positive for nitrites
  • Pre-SWL urine culture reveals >10e5 Colony Forming Unit/ml of bacteria (positive urine culture)
  • Taking antibiotics for Urinary Tract Infection (UTI) or other cause
  • Suspected struvite stone (based on previous stone analysis, or partial staghorn)
  • Presence of nephrostomy tube
  • Requiring cystoscopy and ureteral stent insertion on the day of SWL
  • Presence of Foley catheter or patient on regular clean intermittent catheterization (CIC)
  • Presence of urinary diversion (ie: ileal conduit)
  • History of urosepsis prior to SWL
  • Known allergic reaction to trial antibiotic
  • Previous randomization in this trial
  • In the opinion of the independent treating urologist, it is not in the patient's best interest to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692715


Contacts
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Contact: Kari Tikkinen, MD +358-50-5250971 kari.tikkinen@gmail.com
Contact: Philippe D Violette, MD CM 519-533-6966 philippedenis.violette@gmail.com

Locations
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Brazil
Hospital Sao Luiz Not yet recruiting
São Paulo, Brazil, 05605-050
Contact: Murilo Luz, MD       muriloaluz@gmail.com   
Canada, Quebec
University of Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5H3
Contact: Patrick Richard, MD       Patrick.richard@usherbrooke.ca   
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, 00029
Contact: Kari Tikkinen, MD    +358505250971    kari.tikkinen@gmail.com   
Saudi Arabia
King Abdulaziz University Not yet recruiting
Jeddah, Saudi Arabia, 22252
Contact: Raed Ahzar, MD       raedazhar@gmail.com   
Sponsors and Collaborators
Clinical Urology and Epidemiology Working Group
University of Western Ontario, Canada
Hospital District of Helsinki and Uusimaa
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
King Abdulaziz University
Hospital Sao Luiz
Investigators
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Study Director: Philippe D Violette, MD McMaster University
Study Director: Patrick Richard, MD Université de Sherbrooke
Study Director: Murilo Luz, MD Hospital Sao Luiz
Study Director: Raed Ahzar, MD King Abdulaziz University
  Study Documents (Full-Text)

Documents provided by Kari Tikkinen, Clinical Urology and Epidemiology Working Group:

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Responsible Party: Kari Tikkinen, Adjunct Professor, Departments of Urology and Public Health, Helsinki University Hospital and University of Helsinki, Clinical Urology and Epidemiology Working Group
ClinicalTrials.gov Identifier: NCT03692715     History of Changes
Other Study ID Numbers: CLUE
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kari Tikkinen, Clinical Urology and Epidemiology Working Group:
ureteral stones; ureteral calculi; shockwave lithotripsy
Additional relevant MeSH terms:
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Nephrolithiasis
Kidney Calculi
Ureteral Calculi
Ureterolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Ureteral Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors