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

NCT03709914 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-09-15

No results posted yet for this study

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

Interventions

DRUG

ZTI-01 100 mg/kg

ZTI-01 intravenous (IV)

DRUG

ZTI-01 75 mg/kg

ZTI-01 intravenous (IV)

Sponsors & Collaborators

  • Nabriva Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • John S Bradley, MD · Rady Children's Hospital / Department of Pediatrics, University of California, School of Medicine

  • Jennifer Schranz, MD · Nabriva Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-24
Primary Completion
2025-12-31
Completion
2026-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03709914 on ClinicalTrials.gov