Single-dose ZTI-01 for children under 12 with bacterial infections

Phase 1, Non-comparative, Open-Label Study of Pharmacokinetics and Safety of a Single-Dose of ZTI-01 (Fosfomycin for Injection) in Pediatric Subjects (<12 Years of Age)

This study is testing a single dose of a new antibiotic called ZTI-01 in children under 12 with bacterial infections to see how safe it is and how well it works compared to adults.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: N/A to 11 Years
• Sex: All
• Sponsor: Nabriva Therapeutics AG (industry)
• Locations: 5 sites (Orange, California and 4 other locations)
• Trial ID: NCT03709914 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates the pharmacokinetics of a single dose of ZTI-01 in pediatric patients under 12 years old who require antibiotic therapy. Participants will receive a weight-adjusted dose of ZTI-01 via continuous IV infusion, with cohorts based on age to assess safety and drug concentration in the body. The study aims to establish appropriate dosing for younger children by comparing the effects of the drug to those observed in adults. Blood samples will be collected throughout the study to measure drug concentration and monitor safety through various assessments.

Who should consider this trial

Good fit: Ideal candidates are children under 12 years old who are hospitalized and receiving standard antibiotic treatment for confirmed or suspected bacterial infections.

Not a fit: Patients with a known allergy to fosfomycin or those with impaired renal function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to optimized antibiotic dosing for pediatric patients, improving treatment outcomes.

How similar studies have performed: Other studies have shown success in pharmacokinetic evaluations in pediatric populations, but this specific approach is novel.

Eligibility criteria

Inclusion 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

Exclusion Criteria:

* 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 this trial is running

Orange, California and 4 other locations

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

Study contacts

• Principal investigator: John S Bradley, MD — Rady Children's Hospital / Department of Pediatrics, University of California, School of Medicine
• Study coordinator: Steve Gelone

Conditions: Pediatric ALL, Pediatric PK