Single-Dose ZTI-01 for Pediatric Patients
(Pediatric_PK Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be receiving standard antibiotics for a bacterial infection to participate.
Is ZTI-01 (fosfomycin for injection) safe for use in humans?
ZTI-01 (fosfomycin for injection) has been used in many countries outside the USA since the 1970s for treating various infections, suggesting a history of use in humans. However, specific safety data for pediatric patients or for conditions other than complicated urinary tract infections and acute pyelonephritis is not detailed in the provided research articles.12345
How is the drug ZTI-01 different from other treatments for pediatric patients?
ZTI-01, or fosfomycin for injection, is unique because it is administered as a single-dose intravenous treatment, which can be more convenient and potentially improve adherence compared to multi-dose regimens. This is particularly beneficial for pediatric patients who may have difficulty with frequent dosing.678910
What is the purpose of this trial?
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).
Research Team
John S Bradley, MD
Principal Investigator
Rady Children's Hospital / Department of Pediatrics, University of California, School of Medicine
Jennifer Schranz, MD
Principal Investigator
Nabriva Therapeutics
Eligibility Criteria
This trial is for children under 12 years old who are hospitalized and currently receiving antibiotics for a bacterial infection or as prevention around surgery. They must have normal organ function, not be at risk of pregnancy, and have proper intravascular access. Children with seizure disorders, significant lab abnormalities, known drug allergies, impaired kidney function, or certain viral infections cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single, weight-adjusted dose of ZTI-01 via continuous IV infusion or syringe pump over a 1-hour period
Follow-up
Participants are monitored for safety and pharmacokinetics, including blood collection for fosfomycin concentration measurement and assessment of adverse events
Treatment Details
Interventions
- ZTI-01
ZTI-01 is already approved in United States for the following indications:
- Complicated urinary tract infections (cUTI)
- Acute pyelonephritis (AP)
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Who Is Running the Clinical Trial?
Nabriva Therapeutics AG
Lead Sponsor