Treatment and/or Prevention of Urinary Tract Infections

NCT00801021 | Completed Phase 1

• 2 other identifiers: H-232811R41DK082089-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis; Urinary Tract Infections

Keywords

Cystitis; Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

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

  7 to 10 Days

Secondary Outcomes (1)

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

  28-35 Days

Study Arms (1)

Frio Oral Rinse

EXPERIMENTAL

Prescription Mouth Rinse

Drug: Frio Mouth Rinse

Interventions

Frio Mouth Rinse DRUG

Rinse with 15ml twice daily then expectorate

Also known as: Prescription Mouth Rinse

Frio Oral Rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pregnant adult females;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biomedical Development Corporation: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cystitis; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Study Officials

• Barbara W. Trautner, M.D., Ph.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 8, 2010

Record last verified: 2009-11

Locations

US (1)