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Study of the safety and effects of gepotidacin in children aged 2 to 12 years with bacterial infections such as urinary tract infections

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What is this study about?

This study is being conducted to evaluate how the body processes a new medication called gepotidacin. The research focuses on children between the ages of 2 and 12 who have a suspected or confirmed Urinary Tract Infection, which is an infection in the parts of the body that produce and hold urine, or those receiving prophylaxis, which is medicine taken to prevent an infection from happening.

Participants in this study will receive a single dose of gepotidacin in the form of a powder for oral suspension, which is a liquid medicine made by mixing powder with water. This new medicine will be given in addition to the standard antibacterial treatments currently used to treat infections. During the study, researchers will monitor how the medicine moves through the bloodstream and check for any adverse events, which are unexpected or unwanted side effects. Other measurements include tracking changes in vital signs, such as temperature, blood pressure, and pulse, as well as using an electrocardiogram to check the heart’s electrical activity.

Who Can Join the Study?

  • You must be between 2 and 12 years old at the time of joining the study and weigh at least 10 kilograms.
  • You must be receiving Standard of Care, which means the usual medical treatment provided by doctors, for a suspected or confirmed infection, or to prevent an infection.
  • You must be able to swallow a single dose of gepotidacin (the study medicine) in a powder form mixed with liquid after eating a meal.
  • You must be staying in a hospital or an overnight clinic and be able to stay for at least 24 hours after taking the medicine.
  • You must have an indwelling venous catheter, which is a small tube placed into a vein to give fluids or medicine, as part of your regular medical care.
  • You can be male or female based on the biological sex you were assigned at birth.
  • If applicable, pregnancy tests must be performed to ensure the participant is not pregnant.
  • Female participants who could become pregnant must have a negative pregnancy test using a highly sensitive serum (blood) or urine test before starting.
  • Female participants must not be breastfeeding.
  • A Legally Authorized Representative (LAR), which is a person legally allowed to make decisions for you, must be able to understand, agree to, and sign the permission forms.
  • The participant and their LAR must be willing to follow all study instructions, visit schedules, and medical procedures.

Who Cannot Join the Study?

  • Participants whose Body Mass Index (BMI), which is a measure of body fat based on height and weight, is too low or too high for their age.
  • Participants with high levels of ALT, an enzyme that can indicate liver issues, or high levels of total bilirubin, a substance produced by the liver that can cause jaundice (yellowing of the skin and eyes).
  • People with a history of malignancy (cancer), unusual chromosomes (the structures that carry genetic information), neurological disorders (conditions affecting the brain or nervous system), or seizures (sudden electrical disturbances in the brain).
  • People with chronic immunosuppressive disease (conditions that weaken the immune system), tuberculosis (a serious infection), or acute hepatitis (sudden inflammation of the liver).
  • Participants with cirrhosis (scarring of the liver) or unstable liver or gallbladder diseases, which may include ascites (fluid buildup in the abdomen), encephalopathy (brain dysfunction caused by liver issues), coagulopathy (difficulty with blood clotting), hypoalbuminemia (low levels of a specific protein in the blood), or varices (swollen veins).
  • Participants with congenital long QT syndrome or a known prolongation of the QTc interval, which are issues related to the electrical timing of the heartbeat.
  • People with uncompensated heart failure (the heart cannot pump enough blood) or severe left ventricular hypertrophy (thickening of the heart’s main pumping chamber).
  • Participants with a family history of heart rhythm issues (QT prolongation) or sudden death.
  • People with life-threatening conditions, such as septicemia (blood poisoning), sepsis (a severe body response to infection), or organ failure.
  • Participants with severe renal dysfunction (kidney problems), including anuria (lack of urine production) or oliguria (low urine production).
  • Anyone with medical or surgical conditions that might change how the body absorbs, distributes, metabolizes, or excretes (processes how the body takes in, moves, breaks down, or gets rid of) the study medicine.
  • Participants with significant cardiovascular (heart and blood vessel) history or abnormal ECG (an electrical test of the heart) readings.
  • People with birth defects or abnormalities in the gastrointestinal (GI) tract (the digestive system), heart, or liver.
  • Participants who have had an allergic reaction to the study drug or its components.
  • People who are immunocompromised (having a weakened immune system), such as those with uncontrolled diabetes, transplant recipients, or those taking certain corticosteroid (steroid) medications.
  • Participants with conditions like asthma, peptic ulcer disease (sores in the stomach or intestine), Parkinson disease, or Myasthenia gravis (a condition affecting muscle strength) that require specific medications.
  • People who have recently experienced vasovagal syncope (fainting) or bradycardia (a heart rate that is too slow).
  • Participants taking medications that affect the heart rhythm or strong CYP3A4 inhibitors (a type of drug that interferes with how the liver processes other medicines).
  • Participants with a QTc measurement (a specific part of a heart rhythm test) that is outside the safe range.
  • People with a recent history of hypokalemia (low levels of potassium in the blood) that has not been corrected.
  • Participants planning to use any prohibited medications or treatments during the study.
  • People who have already participated in this specific study or have previously taken gepotidacin.
  • Participants who have received other investigational study products within the last 30 days.
  • Anyone the investigator believes will be unable or unwilling to follow the study rules or complete the follow-up visits.
  • For breastfeeding mothers, those with suspected alcohol or substance use, or those taking medications that could pass into breast milk.
  • Participants with severe hepatic organ dysfunction (serious liver failure).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie Rzeszow Poland

Other Sites

Site Name City Country Status
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Costa del Sol Marbella Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not yet recruiting
05.05.2026
Spain Spain
Not yet recruiting
05.05.2026

Trial locations

Gepotidacin is an experimental antibiotic medication taken by mouth in the form of a powder that is mixed with liquid. It is being studied to see how it moves through the body and how safe it is for children when used alongside standard bacterial infection treatments.

Urinary Tract Infection – This condition occurs when bacteria enter the urinary system and begin to multiply. The infection can affect various parts of the tract, including the bladder or the kidneys. As the bacteria spread, they cause irritation and inflammation within the urinary passages. Symptoms typically develop as the microbial presence increases in the area. The progression depends on how quickly the bacteria colonize the tissues.

Trial ID:
2025-522916-17-00
Protocol code:
222778
Trial Phase:
Human Pharmacology (Phase I) – Other

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