RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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)

Quick Facts

Study Start:2018-05-24

Study Completion:2026-01-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03709914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Steve Gelone

CONTACT

6108166641

Steve.Gelone@nabriva.com

Principal Investigator

John S Bradley, MD

PRINCIPAL_INVESTIGATOR

Rady Children's Hospital / Department of Pediatrics, University of California, School of Medicine

Jennifer Schranz, MD

STUDY_CHAIR

Nabriva Therapeutics

Study Locations (Sites)

Children's Hospital of Orange County

Orange, California, 92868

United States

Rady Children's Hospital

San Diego, California, 92123

United States

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, 40202

United States

Children's Hospital of Michigan

Detroit, Michigan, 48201

United States

University of New Mexico Hospital

Albuquerque, New Mexico, 87106

United States

Collaborators and Investigators

Sponsor: Nabriva Therapeutics AG

John S Bradley, MD, PRINCIPAL_INVESTIGATOR, Rady Children's Hospital / Department of Pediatrics, University of California, School of Medicine
Jennifer Schranz, MD, STUDY_CHAIR, Nabriva Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-24

Study Completion Date2026-01-10

Study Record Updates

Study Start Date2018-05-24

Study Completion Date2026-01-10

Terms related to this study

Keywords Provided by Researchers

Pediatric PK

Additional Relevant MeSH Terms

Pediatric ALL