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Not yet recruitingNCT07881822Updated Oct 23, 2026

Novel Antimicrobial Solution to Prevent Infections

An observational study in Kidney Stone, Infection and Infection Associated With Catheter, sponsored by Ohio State University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Ohio State University · Observational

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

Ureteroscopy is the most common surgical treatment for kidney stones. Although rare, sepsis after ureteroscopy can be a life-threatening complication, occuring in \<3% of patients. There are several risk factors for sepsis including history of positive urine culture, pre-existing ureteral stent, or patients with chronic catheters/tubes. the investigators want to study if an antimicrobial solution with chlorhexidine can prevent infections if instilled into the kidney prior to starting ureteroscopy.

02

Conditions studied

  • Kidney Stone
  • Infection
  • Infection Associated With Catheter
  • Sepsis

Keywords

  • kidney stone
  • nephrolithiasis
  • ureteroscopy
  • infection
  • prevention
  • infectious complications
03

In context

Kidney Calculi

605 studies on the registry are indexed under Kidney Calculi; 164 are open to participants now.

This study's planned enrollment of 50 is below the median of 146 across 114 observational studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Ohio State University is the lead sponsor of 658 studies on the registry; 145 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

anyone who is undergoing ureteroscopy for kidney stone treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • candidate for ureteroscopic stone removal

Exclusion criteria

Exclusion Criteria:

  • \< 18 years old
  • women who are pregnant or breast feeding
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • Observational

    Treatment with antimicrobial solution

    Drug: antimicrobial irrigation

Interventions

  • Drugantimicrobial irrigation

    antimicrobial irrigation to be used with ureteroscopy

06

What researchers measure

Primary outcomes

  1. Emergency room visits

    compare rates of ED visits in the prospective cohort to historic controls

    Time frame: 90 days

Secondary outcomes

  1. allergic reaction

    any reactions to the antimicrobial solution

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • CDC: Summary of Recommendations. Infection Control 2024. Available at: https://www.cdc.gov/infection-control/hcp/cauti/summary-of-recommendations.html, accessed July 24, 2024. 2. Anon: Reducing unnecessary urinary catheter use and other strategies to prevent catheter-associated urinary tract infection: an integrative review | BMJ Quality & Safety. Available at: https://qualitysafety.bmj.com/content/23/4/277, accessed May 15, 2025. 3. Anon: Chlorhexidine Irrigation to Reduce Urinary Tract Infections in Patients with Bladder Cancer Undergoing Radical Cystectomy - NCI. 2016. Available at: https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2024-06347, accessed May 15, 2025. 4. Anon: Bladder instillation with Irrisept in Urinary Retention and Neurogenic Bladder - Clinical Trials Registry - ICH GCP. Available at: https://ichgcp.net/clinical-trials-registry/NCT06163469, accessed May 15, 2025.
  • Atkins L, Sallis A, Chadborn T, Shaw K, Schneider A, Hopkins S, Bunten A, Michie S, Lorencatto F. Reducing catheter-associated urinary tract infections: a systematic review of barriers and facilitators and strategic behavioural analysis of interventions. Implement Sci. 2020 Jul 6;15(1):44. doi: 10.1186/s13012-020-01001-2. PubMed 32624002 ↗
  • Marschall J, Carpenter CR, Fowler S, Trautner BW; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis. BMJ. 2013 Jun 11;346:f3147. doi: 10.1136/bmj.f3147. PubMed 23757735 ↗

Individual participant data

Plan to share: No — This is a proof of concept study with limited outcome data. the investigators will not plan to share individual participant data until later potential randomized prospective trials

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.

Of 39 non-industry observational studies under Kidney Calculi, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 1 month is below that.

Counting every sponsor, half of 41 studies reached it within 42 months; a quarter within 12 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Oct 19, 2026
StartEst.
Nov 2026
Primary completionEst.
Dec 2026
CompletionEst.
Mar 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 2 updates
  1. Oct 23, 2026
    Minor edits only
    + 2 other changes: description and data sharing statement
  2. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881822
Responsible party
Matthew Lee (Principal Investigator, Ohio State University) — Principal investigator
First posted
Oct 19, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

principal investigator
Contact
matthew.lee@osumc.edu
614-685-9181

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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