Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03299387
Status:
WITHDRAWN
Last Update Posted:
2019-06-06
First Post:
2017-09-20
Brief Title:
INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never recruited
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSTANT
Brief 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None