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

September 14, 2023 updated by: Nabriva Therapeutics AG

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Kosair Charities Pediatric Clinical Research Unit
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Children's Hospital of Michigan
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Hospital

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 11 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: ZTI-01 100 mg/kg
ZTI-01 intravenous (IV)
Other Names:
  • IV fosfomycin
  • fosfomycin disodium
  • fosfomycin for injection
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
Drug: ZTI-01 100 mg/kg
ZTI-01 intravenous (IV)
Other Names:
  • IV fosfomycin
  • fosfomycin disodium
  • fosfomycin for injection
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
Drug: ZTI-01 75 mg/kg
ZTI-01 intravenous (IV)
Other Names:
  • IV fosfomycin
  • fosfomycin disodium
  • fosfomycin for injection
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
Drug: ZTI-01 100 mg/kg
ZTI-01 intravenous (IV)
Other Names:
  • IV fosfomycin
  • fosfomycin disodium
  • fosfomycin for injection
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
Drug: ZTI-01 100 mg/kg
ZTI-01 intravenous (IV)
Other Names:
  • IV fosfomycin
  • fosfomycin disodium
  • fosfomycin for injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
By age cohort, determine the ZTI-01 pharmacokinetic area under the plasma concentration-time curve
From time end of 1-hour infusion on Day 1, up to 8-12 hours post infusion on Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety: Treatment Emergent Adverse Events (TEAE)
Time Frame: Baseline (start of dosing) through end of study follow-up (Day 2)
Number and Incidence of TEAEs by age cohort
Baseline (start of dosing) through end of study follow-up (Day 2)
Maximum concentration (Cmax) 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
By age cohort, determine the ZTI-01 pharmacokinetic maximum concentration (Cmax)
From time end of 1-hour infusion on Day 1, up to 8-12 hours post infusion on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nabriva Therapeutics AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jennifer Schranz, MD, Nabriva Therapeutics
  • Principal Investigator: John S Bradley, MD, Rady Children's Hospital / Department of Pediatrics, University of California, School of Medicine

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZTI-01-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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