PK Study of Single-Dose ZTI-01 in Children (<12 Years of Age)

Eligibility Criteria

• * Signed consent/assent
• * Male or female subjects aged from Birth (defined as full term: 37 weeks of gestation or greater) but less than 12 years old
• * Hospitalized, currently receiving antibacterial treatment for confirmed or suspected bacterial infection
• * If of reproductive potential, agrees to avoid becoming pregnant or impregnating a partner from the time of consent through 24 hours after completion of study drug administration
• * Has sufficient intravascular access to receive study drug through peripheral or central line
• * Has history of known allergy, hypersensitivity, or intolerance to oral or intravenous fosfomycin
• * Screening serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3x ULN or total bilirubin \>2x ULN
• * Female is post onset of menarche and currently pregnant, or breast feeding, or has a positive serum or urine β-human chorionic gonadotropin (β-hCG) pregnancy test
• * Impaired renal function at screening based on the Revised Schwartz Formula using actual body height
• * Known infection with immunodeficiency virus (HIV), hepatitis C virus, or hepatitis B virus
• * Other laboratory tests, obtained as standard of care, that are outside the normal limits, considered by the Investigator, to be clinically significant
• * Have surgery scheduled during collection period of plasma for fosfomycin concentrations
• * Weighs outside of the 3rd to less than \<97th percentile based on age
• * History of a seizure disorder requiring ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years
• * Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) of administration of the study drug
• * Has enrolled previously in the current trial or has received ZTI-01 or fosfomycin (IV or oral) for any other reason within the last 30 days
• * Is expected to survive less than 72 hours after completion of study drug administration
• * Plans to use cardiopulmonary bypass, extracorporeal membrane oxygenation, hemodialysis, or peritoneal dialysis during the study
• * Clinically significant abnormalities on the ECG; or have or be at risk for major cardiac events or dysfunction including QTc prolongation, clinically unstable cardiac disease, receipt within 24 hours before the start of study drug of a medication that is labelled to prolong the QT interval, and for breastfed infant subjects only - receipt by the subject's mother within 24 hours before the start of study drug of a medication that is labelled to prolong the QT interval
• * Planned blood transfusion within 24 hours of study drug administration or expected before the end of the PK sampling, or has had significant blood loss (≥5% of total blood volume) within 4 weeks before the screening visit
• * Any condition that, in the opinion of the PI, would compromise the safety of the subject or the quality of the data
• * Subject or caregiver/parent is unable or unwilling to adhere to the study-specified procedures and restrictions