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

  • STATUS
    Recruiting
  • End date
    Jan 10, 2023
  • participants needed
    21
  • sponsor
    Nabriva Therapeutics AG
Updated on 15 March 2022

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).

Description

Based on pre-dose weight on Day -1, subjects weighing within the 3rd to < 97th percentile based on age - will receive a single, weight adjusted dose of ZTI-01 via continuous IV infusion or syringe pump over a 1- hour (+10 min) period. Pediatric subjects participating in this study will be assigned to one of three cohorts based on age:

Cohort 1: ≥ 6 years to <12 years (n=6 PK evaluable subjects) Cohort 2: ≥ 2 years to <6 years (n=6 PK evaluable subjects)

Cohort 3: Birth to < 2 years (n=9 PK evaluable subjects), split into 3 subgroups:

(3a) Birth (defined as full term: 37 weeks of gestations or greater) to < 3 mos, (3b) ≥ 3 mos to < 6 mos, (3c) ≥ 6 mos to < 24 months

Cohorts 1 and 2 will be enrolled first with safety and PK data evaluated before enrolling the youngest Cohort 3. Blood for fosfomycin concentration measurement will be collected throughout the study. Safety will be assessed by monitoring adverse and serious adverse events based on medical history, vital signs, ECG, laboratory assessment and physical examination.

Details
Condition Pediatric ALL
Treatment ZTI-01 100 mg/kg, ZTI-01 75 mg/kg
Clinical Study IdentifierNCT03709914
SponsorNabriva Therapeutics AG
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

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
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