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

Status unconfirmed · Phase 1

Conditions studied: Pediatric ALL

In brief

Phase 1 study, a single dose of ZTI-01 given to pediatric subjects (under 12 years of age) who require antibiotic therapy to see what the body does to the drug (pharmacokinetics) and to compare if these effects are similar to those observed in adults at a 6g ZTI-01 dose. Study will help establish pediatric dosing in younger children by age cohort. This is a multiple-center, open-label, PK study of ZTI-01 (fosfomycin for injection) single dose scaled by allometric weight-modeling from an adult ZTI-01 dose of 6 grams. Eligible subjects must be receiving standard of care antibiotics for proven or suspected bacterial infection or for peri-operative prophylaxis surgery (in or out of hospital).

Key facts

Study ID

NCT03709914

Run by

Nabriva Therapeutics AG

People needed

21

Starts

2018-05-24

Expected to finish

2026-01-10

Last updated by the study team

2023-09-15

Who can join

Age: any, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• Rady Children's Hospital — San Diego, California, United States (enrolling)
• Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States (enrolling)
• Children's Hospital of Michigan — Detroit, Michigan, United States (enrolling)
• University of New Mexico Hospital — Albuquerque, New Mexico, United States (enrolling)

Full record on ClinicalTrials.gov

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