Uncomplicated Urinary Tract InfectionsPhase 1NCT05138822
Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections
A Phase 1 study testing GSK3882347 and Nitrofurantoin in people with Uncomplicated Urinary Tract Infections and Urinary Tract Infections, run by GlaxoSmithKline at 15 sites in United States.
Trial summary
This phase 1b study is a double-blind, double-dummy, nitrofurantoin-controlled study designed to evaluate microbiological response at the test of cure (ToC) visit along with safety, tolerability and pharmacokinetic (PK) response following oral dosing for 5 days of GSK3882347 in an adult female with uncomplicated… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Uncomplicated Urinary Tract Infections, Urinary Tract Infections
- What is being tested?
- GSK3882347 and Nitrofurantoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 15 sitesUnited States
- Study dates
- 18 May 2022to 3 Dec 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
GSK Investigational Site
Anniston, Alabama, 36207
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Chicago, Illinois, 60643
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Doral, Florida, 33166
GSK Investigational Site
Houston, Texas, 77061
GSK Investigational Site
Lomita, California, 90717
GSK Investigational Site
Miami, Florida, 33186
GSK Investigational Site
Miami Lakes, Florida, 33016-1507
GSK Investigational Site
Missouri City, Texas, 77459
GSK Investigational Site
Modesto, California, 95350-5365
GSK Investigational Site
Palmetto Bay, Florida, 33157
GSK Investigational Site
Smithfield, Pennsylvania, 15478
GSK Investigational Site
Sweetwater, Florida, 33172
GSK Investigational Site
The Bronx, New York, 10456
About this study
Official title: A Double-Blind, Double Dummy, Randomized, Phase 1b, Nitrofurantoin Controlled, Repeat Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Microbiological Response of GSK3882347 in Female Participants With Acute Uncomplicated Urinary Tract Infection
This phase 1b study is a double-blind, double-dummy, nitrofurantoin-controlled study designed to evaluate microbiological response at the test of cure (ToC) visit along with safety, tolerability and pharmacokinetic (PK) response following oral dosing for 5 days of GSK3882347 in an adult female with uncomplicated urinary tract infections (uUTI). Comparator nitrofurantoin will be included in the study to ensure unbiased reporting of safety events. The study will be separated into 2 cohorts. Cohort 1 consists of an inpatient treatment period and PK analysis at frequent timepoints. Cohort 2 includes an outpatient treatment period and PK analysis conducted less frequently, at key trough timepoints.
- Being tested
- GSK3882347, Nitrofurantoin, Placebo
- Keywords
- Microbiological response, Urinary tract infections (UTI), GSK3882347, Nitrofurantoin, Pharmacokinetics, Escherichia coli (E. coli)
- Medical subject headings
- Urinary Tract Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3882347Drug
GSK3882347 was administered.
NitrofurantoinDrug
Nitrofurantoin was administered.
PlaceboDrug
Placebo matching GSK3882347 or Nitrofurantoin was administered.
| Study group | Role | What they receive |
|---|---|---|
| GSK3882347+ Placebo | Experimental | Participants received GSK3882347 oral capsules plus placebo oral capsules from Day 1 to Day 5. Receives: Drug: GSK3882347; Drug: Placebo |
| Nitrofurantoin + Placebo | Active comparator | Participants received 100 milligrams (mg) of nitrofurantoin oral capsules plus placebo oral capsules from Day 1 to Day 5. Receives: Drug: Nitrofurantoin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Microbiological Response at the Test of Cure (ToC) Visit
Microbiological response (success/failure) is used to measure microbiological efficacy. Microbiological success was defined as a reduction in E. coli count to less than (<) 10^3 colony-forming units (CFU) per milliliter (CFU/mL) for any E. coli at the ToC visit. Microbiological failure included all other microbiological outcomes (for example but not limited to >=10^3 CFU/mL for any E. coli identified at ToC visit, use of rescue medication prior to ToC, lost to follow-up before ToC, missing/unevaluable samples at ToC, etc).
Measured: Day 10 to Day 13 (ToC Visit)
Secondary outcomes (11)
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Measured: From the first dose of study intervention up to Follow-up Visit (up to Day 31)
Number of Participants With Serious AEs (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability or incapacity; is a congenital anomaly or birth defect; or any other situation according to the medical or scientific judgment of the investigator.
Measured: From the signing of informed consent up to Follow-up Visit (up to Day 31)
Number of Participants With Clinically Significant Changes in Vital Signs Findings
Vital signs included tympanic-measured temperature, pulse and respiratory rate, systolic and diastolic blood pressure. Blood pressure and pulse measurements were assessed in a semi-supine or seated position with a completely automated device and were measured after at least 10 minutes of rest for the participant in a quiet setting without distractions. Clinical significance of any change in vital signs was determined by the investigator.
Measured: Up to Day 31
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECG) Findings
Twelve-lead ECGs were obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. Clinical significance of any change in ECG findings was determined by the investigator.
Measured: Up to Day 31
Number of Participants With Clinically Significant Changes in Hematology Parameters
Blood samples were collected for hematology parameters including platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, reticulocytes, white blood cell (WBC) count (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Clinical significance of any change in hematology parameters was determined by the investigator.
Measured: Up to Day 31
Number of Participants With Clinically Significant Changes in Chemistry Parameters
Blood samples were collected for chemistry parameters including blood urea nitrogen (BUN), creatinine (including estimated glomerular filtration rate [eGFR]), glucose (non-fasting), potassium, sodium, calcium, total and direct bilirubin, total protein, aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT), and alkaline phosphatase. Clinical significance of any change in clinical chemistry parameters was determined by the investigator.
Measured: Up to Day 31
Number of Participants With Clinically Significant Changes in Urinalysis Parameters
Urine samples were collected for the analysis of urine parameters including specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase, microscopic examination (if blood or protein was abnormal), and protein/creatinine ratio. Clinical significance of any change in urinalysis parameters was determined by the investigator.
Measured: Up to Day 31
Cohort 1: Plasma Concentration at the End of the Dosing Interval Tau (Ctau) of GSK3882347 Post-dose on Day 1 and Day 5
Measured: 24 hours post-dose on Day 1 and Day 5
Cohort 1: Urine Concentration of GSK3882347 at 22-24-hour (h) Interval Collection Post-dose on Day 1 and Day 5
Measured: 22-24 hour interval post-dose on Day 1 and Day 5
Cohort 2: Plasma Ctau of GSK3882347 Post-dose on Day 1 and Day 5
Measured: 24 hours post-dose on Day 1 and Day 5
Cohort 2: Urine Concentration of GSK3882347 at 22-24h Interval Collection Post-dose on Day 1 and Day 5
Measured: 22-24 hour interval post-dose on Day 1 and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start18 May 2022
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uncomplicated Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized double-blind study and participants will be randomized to receive either GSK3882347 or nitrofurantoin in a 3:1 allocation ratio using an interactive response technology (IRT).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138822
- Sponsor's protocol ID
- 212943
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2021
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Double Dummy, Randomized, Phase 1b, Nitrofurantoin Controlled, Repeat Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Microbiological Response of GSK3882347 in Female Participants With Acute Uncomplicated Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT05138822
- Acronym / sponsor ID
- 212943
- Keywords
- Microbiological response, Urinary tract infections (UTI), GSK3882347, Nitrofurantoin, Pharmacokinetics, Escherichia coli (E. coli)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 May 2022 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 13 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 1b study is a double-blind, double-dummy, nitrofurantoin-controlled study designed to evaluate microbiological response at the test of cure (ToC) visit along with safety, tolerability and pharmacokinetic (PK) response following oral dosing for 5 days of GSK3882347 in an adult female with uncomplicated urinary tract infections (uUTI). Comparator nitrofurantoin will be included in the study to ensure unbiased reporting of safety events. The study will be separated into 2 cohorts. Cohort 1 consists of an inpatient treatment period and PK analysis at frequent timepoints. Cohort 2 includes an outpatient treatment period and PK analysis conducted less frequently, at key trough timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This will be a randomized double-blind study and participants will be randomized to receive either GSK3882347 or nitrofurantoin in a 3:1 allocation ratio using an interactive response technology (IRT).
| Arm | Type | Receives |
|---|---|---|
| GSK3882347+ Placebo | Experimental | Drug: GSK3882347, Drug: PlaceboParticipants received GSK3882347 oral capsules plus placebo oral capsules from Day 1 to Day 5. |
| Nitrofurantoin + Placebo | Active comparator | Drug: Nitrofurantoin, Drug: PlaceboParticipants received 100 milligrams (mg) of nitrofurantoin oral capsules plus placebo oral capsules from Day 1 to Day 5. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK3882347GSK3882347 was administered. | Drug | GSK3882347+ Placebo |
| NitrofurantoinNitrofurantoin was administered. | Drug | Nitrofurantoin + Placebo |
| PlaceboPlacebo matching GSK3882347 or Nitrofurantoin was administered. | Drug | GSK3882347+ Placebo, Nitrofurantoin + Placebo |
Primary outcome
Number of Participants With Microbiological Response at the Test of Cure (ToC) Visit
Time frame: Day 10 to Day 13 (ToC Visit)
Microbiological response (success/failure) is used to measure microbiological efficacy. Microbiological success was defined as a reduction in E. coli count to less than (<) 10^3 colony-forming units (CFU) per milliliter (CFU/mL) for any E. coli at the ToC visit. Microbiological failure included all other microbiological outcomes (for example but not limited to >=10^3 CFU/mL for any E. coli identified at ToC visit, use of rescue medication prior to ToC, lost to follow-up before ToC, missing/unevaluable samples at ToC, etc).
11 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: From the first dose of study intervention up to Follow-up Visit (up to Day 31)
Number of Participants With Serious AEs (SAEs)
Time frame: From the signing of informed consent up to Follow-up Visit (up to Day 31)
Number of Participants With Clinically Significant Changes in Vital Signs Findings
Time frame: Up to Day 31
Number of Participants With Clinically Significant Changes in Electrocardiograms (ECG) Findings
Time frame: Up to Day 31
Number of Participants With Clinically Significant Changes in Hematology Parameters
Time frame: Up to Day 31
Number of Participants With Clinically Significant Changes in Chemistry Parameters
Time frame: Up to Day 31
Number of Participants With Clinically Significant Changes in Urinalysis Parameters
Time frame: Up to Day 31
Cohort 1: Plasma Concentration at the End of the Dosing Interval Tau (Ctau) of GSK3882347 Post-dose on Day 1 and Day 5
Time frame: 24 hours post-dose on Day 1 and Day 5
Cohort 1: Urine Concentration of GSK3882347 at 22-24-hour (h) Interval Collection Post-dose on Day 1 and Day 5
Time frame: 22-24 hour interval post-dose on Day 1 and Day 5
Cohort 2: Plasma Ctau of GSK3882347 Post-dose on Day 1 and Day 5
Time frame: 24 hours post-dose on Day 1 and Day 5
Cohort 2: Urine Concentration of GSK3882347 at 22-24h Interval Collection Post-dose on Day 1 and Day 5
Time frame: 22-24 hour interval post-dose on Day 1 and Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK3882347 and Nitrofurantoin in people with Uncomplicated Urinary Tract Infections and Urinary Tract Infections, run by GlaxoSmithKline at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Microbiological Response at the Test of Cure (ToC) Visit (time frame: Day 10 to Day 13 (ToC Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.