Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
- Summary
- Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.
- Acronym
- REASSURE
- Short title
- Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
- Official title
- A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2023-11-21
- First posted
- 2022-10-18
- Registry last updated
- 2024-11-20
- Primary completion date
- 2023-11-03
- Start date
- 2022-10-18
- Actual participants
- 2,229
- Participants
- 2,229
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Iterum Therapeutics, International Limited
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05584657
- ClinicalTrials.gov ID
- NCT05584657
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Overall Success
Timeframe: Day 12+/-1 day
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Overall Success Susceptible Population
Timeframe: Day 12+/-1 day
Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Clinical Success Modified Intent-to-treat Population
Timeframe: Day 12+/-1 day
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Clinical Success
Timeframe: Day 12+/-1 day
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Clinical Success Susceptible Population
Timeframe: Day 12+/-1 day
Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms
Microbiologic Success
Timeframe: Day 12+/-1 day
Eradication of the Baseline Pathogen
Microbiologic Success Susceptible Population
Timeframe: Day 12+/-1 day
Microbiologic Success: Eradication of the Baseline Pathogen
- Sex
- Female
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI
- Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.
- A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine
- Presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature > 38° Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
- Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
- Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.
- Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis
- Ongoing urinary retention
- Neurogenic bladder
- Current resident of a long-term care facility
- Instrumentation of urinary tract in the previous 30 days
- An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract
- Any history of trauma to the pelvis or urinary tract
- Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant
- History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients
- Medical FacilityCullman, United States
- Medical FacilitySaraland, United States
- Medical FacilitySheffield, United States
- Medical FacilityPeoria, United States
- Medical Facility3Phoenix, United States
- Medical FacilityPhoenix, United States
- Medical Facility2Phoenix, United States
- Medical FacilityTucson, United States
- Medical Facility2Hot Springs, United States
- Medical FacilityHot Springs, United States
- Medical FacilityBakersfield, United States
- Medical FacilityChula Vista, United States
- Medical FacilityFullerton, United States
- Medical FacilityGarden Grove, United States
- Medical FacilityHuntington Beach, United States
- Medical Facility 2Huntington Park, United States
- Medical FacilityHuntington Park, United States
- Medical FacilityIrvine, United States
- Medical FacilityLa Mesa, United States
- Medical FacilityLancaster, United States
- Medical FacilityLomita, United States
- Medical Facility2Los Angeles, United States
- Medical FacilityLos Angeles, United States
- Medical FacilityPomona, United States
- Medical FacilitySacramento, United States
And 142 more, listed on the interactive page.
- PubMed 40552968Related publication
Related records
Drugs (4)
Lead sponsors (1)
Conditions (2)
- Cystitis
- Urinary tract infection Primary condition