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Treatment and/or Prevention of Urinary Tract Infections (UTI)

Primary Purpose

Cystitis, Urinary Tract Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Frio Mouth Rinse

About this trial

This is an interventional prevention trial for Cystitis focused on measuring Cystitis, Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Non-pregnant adult females;
18 years of age or older;
Clinical signs with one or more symptoms of a UTI (e.g., dysuria, frequency, urgency, suprapubic pain) with onset of symptoms < 72 hours prior to study entry;
One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with > 5 wbc/hpf.
A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism

Exclusion Criteria:

Males;
Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control;
Three or more episodes of acute uncomplicated UTI in the past 12 months;
Known structural abnormality that would predispose the participant to reflux or urinary retention;
Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder;
Patients with significant impaired immunity secondary to chemotherapy, oral corticosteroids, or HIV;
Patients with onset of symptoms > 72 hours prior to entry;
Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection;
Patients with purported hypersensitivity to iodine;
Patients with history of thyroid disease;
Patients who received treatment with other antimicrobials within 48 hours prior to entry;
Any significant medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation; inability to use an oral rinse;
Use of concomitant medication that, in the opinion of the Study Directors, might interfere with the outcome of the study.

Sites / Locations

Ben Taub General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Frio Oral Rinse

Arm Description

Prescription Mouth Rinse

Outcomes

Primary Outcome Measures

The primary efficacy endpoint is the reduction of the baseline pathogen at the Days 7 to 10 "Test of Cure" visit.

Secondary Outcome Measures

The secondary efficacy endpoint of microbiological evaluation classified into four categories (i.e., Eradication, Persistence, Superinfection, and New Infection)

Full Information

NCT ID

NCT00801021

First Posted

December 2, 2008

Last Updated

March 4, 2010

Sponsor

Biomedical Development Corporation

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00801021

Brief Title

Treatment and/or Prevention of Urinary Tract Infections

Acronym

UTI

Official Title

Treatment and/or Prevention of Urinary Tract Infections

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Biomedical Development Corporation

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Baylor College of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections.

Detailed Description

A 7-day treatment with a 28-day follow up has been designed as a "before and after" assessment of the clinical signs and symptoms of an uncomplicated urinary tract infection and the reduction/eradication of urinary pathogens. Enrollment is targeted to achieving 20 evaluable subjects by the end of the study. After enrolling in the trial at Day 0 (first day of dosing), participants will report back to the study site at Days 3, 7, and 28. At Day 3 or any time thereafter, worsening of symptoms and/or increases in quantitative bacteria counts will result in removal from the trial and prescription of a rescue medication, which will be selected based on microbial susceptibility testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystitis, Urinary Tract Infections

Keywords

Cystitis, Urinary Tract Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Frio Oral Rinse

Arm Type

Experimental

Arm Description

Prescription Mouth Rinse

Intervention Type

Drug

Intervention Name(s)

Frio Mouth Rinse

Other Intervention Name(s)

Prescription Mouth Rinse

Intervention Description

Rinse with 15ml twice daily then expectorate

Primary Outcome Measure Information:

Title

The primary efficacy endpoint is the reduction of the baseline pathogen at the Days 7 to 10 "Test of Cure" visit.

Time Frame

7 to 10 Days

Secondary Outcome Measure Information:

Title

The secondary efficacy endpoint of microbiological evaluation classified into four categories (i.e., Eradication, Persistence, Superinfection, and New Infection)

Time Frame

28-35 Days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Non-pregnant adult females; 18 years of age or older; Clinical signs with one or more symptoms of a UTI (e.g., dysuria, frequency, urgency, suprapubic pain) with onset of symptoms < 72 hours prior to study entry; One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with > 5 wbc/hpf. A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism Exclusion Criteria: Males; Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control; Three or more episodes of acute uncomplicated UTI in the past 12 months; Known structural abnormality that would predispose the participant to reflux or urinary retention; Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder; Patients with significant impaired immunity secondary to chemotherapy, oral corticosteroids, or HIV; Patients with onset of symptoms > 72 hours prior to entry; Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection; Patients with purported hypersensitivity to iodine; Patients with history of thyroid disease; Patients who received treatment with other antimicrobials within 48 hours prior to entry; Any significant medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation; inability to use an oral rinse; Use of concomitant medication that, in the opinion of the Study Directors, might interfere with the outcome of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara W. Trautner, M.D., Ph.D.

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ben Taub General Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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Treatment and/or Prevention of Urinary Tract Infections

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