UrolithiasisPhase 3NCT01873690
Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)
A Phase 3 study testing Ciprofloxacin in people with Urolithiasis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Ciprofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Hospital, St. Joseph's Health Care London
London, Ontario, N6A 4V2
About this study
Official title: A Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection
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.
- Conditions
- Urolithiasis
- Being tested
- Ciprofloxacin, Placebo
- Keywords
- Antibiotics, Shock Wave Lithotripsy, Urinary Tract Infection
- Medical subject headings
- Urolithiasis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Also called Ciprofloxacin Hydrochloride
Once, 400 mg IV
PlaceboDrug
5% Dextrose in water
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Ciprofloxacin | Active comparator | Ciprofloxacin Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post SWL Day 7
Secondary outcomes (4)
Bacteriuria post-SWL (≥105 cfu/ml)
Measured: 7-14 days
Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency)
Measured: 7-14 days
Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C)
Measured: 7-14 days
Change in Urinary Symptom Score(reported as positive or negative integer)
Measured: 7 - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Due to the low recruitment rate and the large number lost to follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Hassan Razvi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Hassan Razvi, MD, FRCSC, Principal investigator, Western University & Lawson Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873690
- Sponsor's protocol ID
- 103696
- Status last verified
- Feb 2016
- First submitted
- 3 Jun 2013
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT01873690
- Acronym / sponsor ID
- 103696
- Conditions
- Urolithiasis
- Keywords
- Antibiotics, Shock Wave Lithotripsy, Urinary Tract Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the low recruitment rate and the large number lost to follow-up
- Enrolment
- 360 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Ciprofloxacin | Active comparator | Drug: CiprofloxacinCiprofloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofloxacinAlso: Ciprofloxacin HydrochlorideOnce, 400 mg IV | Drug | Ciprofloxacin |
| Placebo5% Dextrose in water | Drug | Placebo |
Primary outcome
Impact of antibiotic prophylaxis on the rate of urinary tract infection
Time frame: Post SWL Day 7
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).
4 secondary outcomes
Bacteriuria post-SWL (≥105 cfu/ml)
Time frame: 7-14 days
Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency)
Time frame: 7-14 days
Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C)
Time frame: 7-14 days
Change in Urinary Symptom Score(reported as positive or negative integer)
Time frame: 7 - 14 days
Results and safety
The study was stopped early (reason given: Due to the low recruitment rate and the large number lost to follow-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Razvi, MD, FRCSC principal investigator
Western University & Lawson Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacin in people with Urolithiasis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the low recruitment rate and the large number lost to follow-up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of antibiotic prophylaxis on the rate of urinary tract infection (time frame: Post SWL Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.