PK Study of Single-Dose ZTI-01 in Children (<12 Years of Age)
Status:
Recruiting
Trial end date:
2022-01-10
Target enrollment:
Participant gender:
Summary
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).