INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI

Urinary Tract Infections Clinical Trial

— INSTANT  

Official title:

INtravesical Antimicrobial Agents Versus STANDard Oral Antibiotics for the Treatment of Acute Urinary Tract Infection in Women With Recurrent Urinary Tract Infection (INSTANT Study)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03299387
• Other study ID #: 11-002887
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 28, 2017
• Est. completion date: July 5, 2018

Study information

• Verified date: June 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.

Description:

Each participant once enrolled returns with an active Urinary Tract Infection (UTI), confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin treatment for 7 days, or intravesical gentamicin instillation once a day for three days. Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and with a repeated questionnaire for symptom relief.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 5, 2018
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

• Patients who report that they are pregnant.

• Patients with a positive urine pregnancy test

• Patients with a history of renal transplantation.

• Patients with bladder augmentation procedures using bowel.

• Patients with poorly controlled Type II diabetes, Hgb A1C >6.5%

• Patients with spinal cord injury, ASIA Impairment Scale of C or higher.

• Patients with pelvic surgery within 6 months.

• Patients with urologic procedure within 6 months.

• Patients with a history of reconstructive urologic surgery, such as reflux, congenital abnormality.

• Immunocompromised patients being treated for malignancy or a history of actively treated malignancy within 5 years.

• Patients with active systemic autoimmune disease.

• Patients on systemic immunosuppression.

• Use of antibiotic prophylaxis within 6 months

• Use of antibiotics within 10 days of active infection

• Allergy/sensitivity to gentamicin or nitrofurantoin.

• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

• Inability or unwillingness of individual to give written informed consent.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Drug:
• Nitrofurantoin
Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days
• Gentamicin
Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microbiologic effect of a chronic acute Urinary Tract Infection	Microbiological culture growth of susceptible organisms obtained on day 0, compared with voided urine culture as no growth in 24-48 hours obtained at 7-10 days	baseline, 7-10 days
Primary	Change in symptomatic relief of a chronic acute Urinary Tract Infection	Completion of a Symptom Urinary Tract Questionnaire. Tracking the symptoms in the past 24 hours. Indicating how severe and how bothersome they were. Severe ranging from 0 (Did not have) to 3 (Severe). Bothersome ranging from 0 (Not at all) to 3 (A lot)	baseline, 7-10 days
Secondary	To establish the clinical FTE needs for providing urgent intravesical treatments	Nursing needs to provide intravesical treatments of acute Urinary Tract Infections (UTI) in women with chronic recurrent UTIs. Measured in amount of participants and FTE requirement for nursing staff.	baseline, through stufy completion, an average of one year

External Links

•   Mayo Clinic Clinical Trials