Clareo Health | Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Participants must be greater than or equal to (\>=)18 years of age and less than or equal to (\<=)70 years
The participant has 2 or more of the following clinical signs and symptoms of uncomplicated urinary tract infections (uUTI) with onset less than (\<) 96 hours of the screening assessment: dysuria, frequency, urgency, or lower abdominal pain
Participant has nitrite OR pyuria (≥ 10 white blood cells/ cubic millimeter \[WBC/mm\^3\], OR \> 5 WBC/high power field \[HPF\]) OR the presence of 2+ leukocyte esterase from a pre-treatment clean-catch midstream urine sample
Participants with body mass index (BMI) \>= 19.0 kilograms per square meter (kg/m\^2)
A female participant is eligible to participate who is not pregnant (as confirmed by a highly sensitive pregnancy test before the first dose of study intervention) or breastfeeding and one of the following conditions apply: 1) Woman participant of non-childbearing potential (WONCBP) Or 2) Woman participant of childbearing potential (WOCBP) using a contraceptive method that is highly effective, with a failure rate of \< 1 percentage (%), during the study intervention period and up to 5 days post intervention
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
You may not be if
The participant has a BMI \>= 40.0 kg/ m\^2 or a BMI \>=35.0 kg/ m\^2 with obesity related health conditions such as high blood pressure or uncontrolled diabetes (non-fasting glucose value \>300 milligram/deciliter \[mg/dL\])
The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications
The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis
The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction of the urinary tract, primary renal disease, or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract
The participant has an indwelling catheter, nephrostomy, ureteral stent, or other foreign material in the urinary tract
The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptoms onset \>=96 hours before the screening assessment, or a temperature \>=101-degree Fahrenheit (°F) (\>=38 degree Celsius \[°C\]), flank pain, chills, or any other manifestations suggestive of upper UTI
The participant has anuria, oliguria, or significant impairment of renal function
The participant presents at enrollment with a suspected sexually transmitted infection
A positive confirmation of Coronavirus Disease 2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19
The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week or 10 weeks for dalbavancin or oritavancin before study entry.
Regular alcohol consumption within 6 months prior to the study with an average weekly intake of \>14 units for females and one unit is equivalent to approximately 8 g of alcohol: a half-pint (250 mL) of beer, one glass (125 mL) of wine or one (35 mL) measure of spirits
Unable to take nitrofurantoin. E.g. hypersensitivity to the active substance
