Efficacy of Antimicrobial Prophylaxis for Shock Wave Lith... | NCT01873690

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the low recruitment rate and the large number lost to follow-up

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jun 3, 2013

First Submission Date that Met QC Criteria

Jun 7, 2013

First Posted Date

Jun 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2016

Last Update Posted Date

Feb 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hassan Razvi, Principle Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Name	Class
The Physicians' Services Incorporated Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research study is to test whether administering one dose of an antibiotic before a routine shock wave lithotripsy procedure is more effective at avoiding any urinary infections compared to not taking an antibiotic. This is an important topic to study because urinary tract infections are one of the most common complications after this procedure and there is no clear standard of care regarding the use of pre-procedure antibiotics. Our study results will benefit future patients either by decreasing the rate of infections or decreasing the use of unnecessary antibiotics.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo	Drug: Placebo
Ciprofloxacin	Active Comparator	Ciprofloxacin	Drug: Ciprofloxacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciprofloxacin	Drug	Once, 400 mg IV	Ciprofloxacin	Ciprofloxacin Hydrochloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of antibiotic prophylaxis on the rate of urinary tract infection	Our primary outcome will be a composite endpoint comprised of: Positive post-SWL urine culture (≥ 105 colony forming units / millilitre (CFU/ml), 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).	Post SWL Day 7

Secondary Outcomes

Measure	Description	Time Frame
Bacteriuria post-SWL (≥105 cfu/ml)		7-14 days
Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency)		7-14 days
Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for SWL at St. Joseph's Hospital;
18 years of age or older;
Willing and able to complete Questionnaires;
Willing to submit urine sample for analysis at Day 7;
Able to read and speak English.

Exclusion Criteria:

Pre-SWL urine analysis positive for nitrites or urine culture reveals >105 CFU/ml of bacteria (positive urine culture);
Taking antibiotics for UTI or other cause;
Requires an antibiotic post SWL;
Suspected struvite stone (based on previous stone analysis, or partial staghorn);
Presence of nephrostomy tube;
Requiring cystoscopy on the day of SWL;
Requiring ureteral stent on the day of SWL;
Presence of indwelling urinary catheter or on regular clean intermittent catheterization (CIC);
Presence of urinary diversion (ie: ileal conduit);
Any history of urosepsis;
Known allergic reaction to ciprofloxacin/quinolones;
Patient known to be pregnant;
Previous randomization in this trial;
In the opinion of the urologist, it is not in the patient's best interest to participate.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hassan Razvi, MD, FRCSC	Western University & Lawson Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Hospital, St. Joseph's Health Care London		London	Ontario	N6A 4V2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D052878	Urolithiasis
D014552	Urinary Tract Infections

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D007239	Infections

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds