Recruiting
Phase 1

ZTI-01

Sponsor:

Nabriva Therapeutics AG

Code:

NCT03709914

Conditions

Pediatric ALL

Eligibility Criteria

Sex: All

Age: 0 - 11

Healthy Volunteers: Not accepted

Interventions

ZTI-01 100 mg/kg

ZTI-01 75 mg/kg

Study Details

Brief 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).

Conditions

Pediatric ALL

Study ID

NCT03709914

Start date

May 24, 2018

Status verified date

Sep, 2023

Completion date

Jan 10, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 11

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: ZTI-01 Cohort 1 ≥ 6 to <12 years of age

ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age

experimental: ZTI-01 Cohort 2 ≥ 2 to <6 years of age

ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age

experimental: ZTI-01 Cohort 3a Birth to < 3 mos of age

ZTI-01 (fosfomycin IV) 75 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age

experimental: ZTI-01 Cohort 3b ≥ 3 to < 6 mos of age

ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age

experimental: ZTI-01 Cohort 3c ≥ 6 to < 24 mos of age

ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age

Interventions

ZTI-01 100 mg/kg

ZTI-01 intravenous (IV)

ZTI-01 75 mg/kg

ZTI-01 intravenous (IV)

Primary outcome measure

  • Area under plasma concentration-time curve (AUC) after a single dose of ZTI-01 [ Time Frame: From time end of 1-hour infusion on Day 1, up to 8-12 hours post infusion on Day 1 ]

Central Contacts and Locations

Central contacts

Steve Gelone

6108166641Steve.Gelone@nabriva.com

Locations

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Kosair Charities Pediatric Clinical Research Unit

Recruiting

Louisville, Kentucky, United States, 40202

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

University of New Mexico Hospital

Recruiting

Albuquerque, New Mexico, United States, 87106

More Information

Sponsor

Nabriva Therapeutics AG

Last update posted

Sep 15, 2023

Last verified

Sep, 2023

Keywords

  • Pediatric PK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nabriva Therapeutics AG on 2023-09-15.