Urinary Tract InfectionsPhase 1NCT07371429
A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics
A Phase 1 study testing Gepotidacin and SOC in people with Urinary Tract Infections, run by GlaxoSmithKline at 4 sites in United States.
Trial summary
The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment with antibacterials for a confirmed or suspected infection or for its prevention. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Gepotidacin and SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Sep 2026to 23 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants having ≥2 to <12 years of age at the time of signing the informed consent/assent and have a body weight >=10 kilograms (kg).
- Participants receiving SoC antibacterial therapy for a confirmed/suspected infection or for prophylaxis AND is able to take a single dose of the powder for oral suspension formulation of gepotidacin after a meal.
- Participants either hospitalized or in an overnight clinic. Participant is expected to be in hospital/clinic for at least 24 hours post administration of study intervention.
- Participant has an indwelling venous catheter in place as part of the clinical SoC.
- Male or female according to their reproductive organs at birth.
- Pregnancy testing is required as appropriate for the age, sexual activity, and sexual maturity of pediatric participants and as required by local regulations. Investigator should apply clinical judgment.
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- A female participant is eligible to participate if she is a WOCBP who is not pregnant as confirmed by a high sensitivity serum or urine pregnancy test at baseline (Day 1) regardless of current or prior contraception use or abstinence, is not breastfeeding, or is not a WOCBP.
- Participant LAR(s) who has the ability to understand, agree to, and sign the informed consent form before initiation of any protocol-related procedures; participant has the ability to give documented assent.
- Participant and participant's LAR are willing and able to comply with study instructions, study visits, and procedures.
Who cannot join
- Participants having a BMI-for-age that is less than the 5th percentile or greater than the 95th percentile based on the CDC percentiles [CDC NCHS Growth Charts].
- Participants having a clinically significant medical history, including malignancy, significant chromosome abnormality, neurological disorder or history of seizure (excluding simple febrile seizure), chronic immunosuppressive disease, active tuberculosis or acute hepatitis.
- Participants with serious disease/condition that could be imminently life-threatening (e.g. is clinically/hemodynamically unstable, is septicemic, has severe sepsis, organ failure, requiring ITU care or has clinical laboratory tests either nonstable or anticipated to be nonstable) or the participant is unlikely to survive for the duration of the study period.
- The participant has severe renal organ dysfunction or has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 mL/min or clinically significant elevated serum creatinine as determined by the investigator).
- The participant has a significant CV history or based on investigator judgment any clinically significant abnormal ECG reading at Screening/baseline (e.g., prolonged QT syndrome).
- The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of complications (e.g., uncontrolled diabetes in the judgment of the investigator, transplant recipients (with the exception of cornea and autologous BMT), participants with clinically significant persistent granulocytopenia [absolute neutrophil count <1000/μL], and participants receiving immunosuppressive therapy, including corticosteroid therapy at a dose of >1 mg/kg/day of prednisolone or equivalent for >1 week or 0.5-<1 mg/kg/day prednisolone or equivalent for >2 weeks). Participants aged ≥6 years with a known CD4 count of <200 cells/mm3 and participants aged <6 years with a known CD4 count of <500 cells/mm3 are to not be enrolled.
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- The participant has any of the following medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as:
- Poorly controlled asthma or obstructive pulmonary disease at baseline and, in the opinion of the investigator, not stable on current therapy.
- Active peptic ulcer disease
- Juvenile Parkinson disease
- Juvenile Myasthenia gravis
- The participant has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention (e.g., ileostomy or malabsorption syndrome).
- The participant plans to use any of the prohibited medications or nondrug therapies from the Baseline Visit through Follow-up Visit at 7 ±3 days after the single dose of study intervention.
- The participant has received a prohibited medication within 14 days or 5 half-lives prior to gepotidacin administration, whichever is longer.
- The participant has been previously enrolled in this study or has previously been treated with gepotidacin.
- The participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives prior to gepotidacin administration, whichever is longer.
- The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
- If the child is being breastfed:
- There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother.
- The breastfeeding mother is taking any medication or any substances containing any of the medications included in the prohibited medication list with known or unknown lactation excretion.
- The participant has severe hepatic organ dysfunction.
- The participant has an ALT value >2 × ULN.
- The participant has a total bilirubin >1.5xULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is ≤1.5xULN.
- Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
- The participant has congenital long QT syndrome or known prolongation of the QTc interval.
- The participant has uncompensated heart failure.
- The participant has severe left ventricular hypertrophy.
- The participant has a family history of QT prolongation or sudden death or history of sudden infant death in a sibling.
- The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months.
- The participant is taking QT-prolonging drugs or drugs known to increase the risk of TdP per the ww.crediblemeds.org. "Known Risk of TdP" category at the time of the Baseline Visit, which cannot be safely discontinued from the Baseline Visit (Day 1) through 7 (+3) days after the single dose of study intervention; or the participant is taking a strong CYP3A4 inhibitor.
- The participant has a mean triplicate QTc >450 msec or a mean triplicate QTc >480 msec for participants with complete bundle branch block.
- The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
GSK Investigational Site
Baltimore, Maryland, 21827
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Orange, California, 92868
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Shreveport, Louisiana, 71101
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
GSK Investigational Site
St Louis, Missouri, 63110-1010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: Phase 1, Open-Label, Single Arm (Non-comparator) Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Oral Gepotidacin in Addition to Antibacterial Standard of Care in Pediatric Participants From 2 to Less Than 12 Years of Age With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis With Antibiotics
The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment with antibacterials for a confirmed or suspected infection or for its prevention.
- Conditions
- Urinary Tract Infections
- Being tested
- Gepotidacin, SOC
- Keywords
- Gepotidacin, Antibacterial Standard of Care, Antibiotics, Bacterial Infection, Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GepotidacinDrug
Gepotidacin will be administered
SOCDrug
SOC will be administered
| Study group | Role | What they receive |
|---|---|---|
| Gepotidacin plus Standard of care (SOC) | Experimental | Single Arm Receives: Drug: Gepotidacin; Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin
Measured: Up to 24 hours post dose (Day 1)
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of gepotidacin
Measured: Up to 24 hours post dose (Day 1)
Maximum observed plasma concentration (Cmax) of gepotidacin
Measured: Up to 24 hours post dose (Day 1)
Apparent oral clearance (CL/F) of gepotidacin
Measured: Up to 24 hours post dose (Day 1)
Apparent volume of distribution (Vz/F) of gepotidacin
Measured: Up to 24 hours post dose (Day 1)
Terminal phase half-life (t1/2) of gepotidacin
Measured: Up to 24 hours post dose (Day 1)
Secondary outcomes (5)
Number of participants with Adverse events (AEs), Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs)
Measured: Up to 7 days (±3 days)
Change from baseline in vital signs: Temperature
Measured: At 2 hours (±15 mins) post dose on Day 1
Change from baseline in vital signs: Blood Pressure
Measured: At 2 hours (±15 mins) post dose on Day 1
Change from baseline in vital signs: Pulse Rate
Measured: At 2 hours (±15 mins) post dose on Day 1
Change from baseline in Electrocardiogram (ECG)
Measured: At 2 hours (±15 mins) post dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start18 Sep 2026 (estimated)
- Primary completion23 Aug 2027 (estimated)
- Study completion23 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371429
- Sponsor's protocol ID
- 222778
- Other IDs
- 2025-522916-17, HSSO100201300011C, 2025
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Single Arm (Non-comparator) Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Oral Gepotidacin in Addition to Antibacterial Standard of Care in Pediatric Participants From 2 to Less Than 12 Years of Age With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis With Antibiotics
- ClinicalTrials.gov ID
- NCT07371429
- Acronym / sponsor ID
- 222778
- Conditions
- Urinary Tract Infections
- Keywords
- Gepotidacin, Antibacterial Standard of Care, Antibiotics, Bacterial Infection, Urinary Tract Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- 23 Aug 2027 (estimated)
- Study completion
- 23 Aug 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment with antibacterials for a confirmed or suspected infection or for its prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gepotidacin plus Standard of care (SOC) | Experimental | Drug: Gepotidacin, Drug: SOCSingle Arm |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Participants having ≥2 to <12 years of age at the time of signing the informed consent/assent and have a body weight >=10 kilograms (kg).
- Participants receiving SoC antibacterial therapy for a confirmed/suspected infection or for prophylaxis AND is able to take a single dose of the powder for oral suspension formulation of gepotidacin after a meal.
- Participants either hospitalized or in an overnight clinic. Participant is expected to be in hospital/clinic for at least 24 hours post administration of study intervention.
- Participant has an indwelling venous catheter in place as part of the clinical SoC.
- Male or female according to their reproductive organs at birth.
Key exclusion criteria (32 listed)
- Participants having a BMI-for-age that is less than the 5th percentile or greater than the 95th percentile based on the CDC percentiles [CDC NCHS Growth Charts].
- Participants having a clinically significant medical history, including malignancy, significant chromosome abnormality, neurological disorder or history of seizure (excluding simple febrile seizure), chronic immunosuppressive disease, active tuberculosis or acute hepatitis.
- Participants with serious disease/condition that could be imminently life-threatening (e.g. is clinically/hemodynamically unstable, is septicemic, has severe sepsis, organ failure, requiring ITU care or has clinical laboratory tests either nonstable or anticipated to be nonstable) or the participant is unlikely to survive for the duration of the study period.
- The participant has severe renal organ dysfunction or has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 mL/min or clinically significant elevated serum creatinine as determined by the investigator).
- The participant has a significant CV history or based on investigator judgment any clinically significant abnormal ECG reading at Screening/baseline (e.g., prolonged QT syndrome).
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 |
|---|---|---|
| GepotidacinGepotidacin will be administered | Drug | Gepotidacin plus Standard of care (SOC) |
| SOCSOC will be administered | Drug | Gepotidacin plus Standard of care (SOC) |
Primary outcome
AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin
Time frame: Up to 24 hours post dose (Day 1)
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of gepotidacin
Time frame: Up to 24 hours post dose (Day 1)
Maximum observed plasma concentration (Cmax) of gepotidacin
Time frame: Up to 24 hours post dose (Day 1)
Apparent oral clearance (CL/F) of gepotidacin
Time frame: Up to 24 hours post dose (Day 1)
Apparent volume of distribution (Vz/F) of gepotidacin
Time frame: Up to 24 hours post dose (Day 1)
Terminal phase half-life (t1/2) of gepotidacin
Time frame: Up to 24 hours post dose (Day 1)
5 secondary outcomes
Number of participants with Adverse events (AEs), Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs)
Time frame: Up to 7 days (±3 days)
Change from baseline in vital signs: Temperature
Time frame: At 2 hours (±15 mins) post dose on Day 1
Change from baseline in vital signs: Blood Pressure
Time frame: At 2 hours (±15 mins) post dose on Day 1
Change from baseline in vital signs: Pulse Rate
Time frame: At 2 hours (±15 mins) post dose on Day 1
Change from baseline in Electrocardiogram (ECG)
Time frame: At 2 hours (±15 mins) post dose on Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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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.
4 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 Gepotidacin and SOC in people with Urinary Tract Infections, run by GlaxoSmithKline at 4 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 9 inclusion and 32 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin (time frame: Up to 24 hours post dose (Day 1)). The study lists 6 primary outcomes in all. 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 28 Sep 2026.