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Antibiotic

Single-Dose ZTI-01 for Pediatric Patients. However, without clear information linking ZTI-01 to Acute Lymphoblastic Leukemia treatment within your description, I cannot confidently include "Acute Lymphoblastic Leukemia" as part of this clinical trial's title based solely on its presence on a layman condition list. If you have more details connecting ZTI-01 to leukemia treatment specifically, please provide them so I can give an accurate title (Pediatric_PK Trial)

Phase 1
Recruiting
Led By John S Bradley, MD
Research Sponsored by Nabriva Therapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time end of 1-hour infusion on day 1, up to 8-12 hours post infusion on day 1
Awards & highlights

Pediatric_PK Trial Summary

This trial is to see what effects a single dose of ZTI-01 has on children under the age of 12, and to compare those effects to adults who have received a 6g dose of the drug. The study will help establish an appropriate dosing for younger children by age cohort.

Who is the study for?
This trial is for children under 12 years old who are hospitalized and currently receiving antibiotics for a bacterial infection or as prevention around surgery. They must have normal organ function, not be at risk of pregnancy, and have proper intravascular access. Children with seizure disorders, significant lab abnormalities, known drug allergies, impaired kidney function, or certain viral infections cannot participate.Check my eligibility
What is being tested?
The study tests how a single dose of ZTI-01 (an antibiotic) behaves in the bodies of children compared to adults. It's an open-label Phase 1 trial across multiple centers aiming to find the right pediatric dosage by scaling from an adult dose using weight-based calculations.See study design
What are the potential side effects?
While specific side effects for ZTI-01 in children aren't listed here, common antibiotic-related side effects can include digestive issues like diarrhea or nausea, potential allergic reactions ranging from rashes to more severe responses depending on sensitivity to fosfomycin.

Pediatric_PK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 12 years old and was born at or after 37 weeks of gestation.
Select...
I am in the hospital getting antibiotics for a bacterial infection.

Pediatric_PK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time end of 1-hour infusion on day 1, up to 8-12 hours post infusion on day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time end of 1-hour infusion on day 1, up to 8-12 hours post infusion on day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under plasma concentration-time curve (AUC) after a single dose of ZTI-01
Secondary outcome measures
Maximum concentration (Cmax) after a single dose of ZTI-01
Safety: Treatment Emergent Adverse Events (TEAE)

Side effects data

From 2016 Phase 1 trial • 19 Patients • NCT02570074
79%
Diarrhoea
11%
Dermatitis contact
11%
Abdominal Pain
5%
Abdominal distension
5%
Nausea
5%
Headache
5%
Vomiting
5%
Oropharyngeal pain
5%
Fatigue
5%
Madarosis
5%
Dysuria
5%
Sinus Congestion
5%
Transaminases increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fosfomycin - 3 Doses QoD
Fosfomycin - 7 Doses QD

Pediatric_PK Trial Design

5Treatment groups
Experimental Treatment
Group I: ZTI-01 Cohort 3c ≥ 6 to < 24 mos of ageExperimental Treatment1 Intervention
ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age
Group II: ZTI-01 Cohort 3b ≥ 3 to < 6 mos of ageExperimental Treatment1 Intervention
ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age
Group III: ZTI-01 Cohort 3a Birth to < 3 mos of ageExperimental Treatment1 Intervention
ZTI-01 (fosfomycin IV) 75 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age
Group IV: ZTI-01 Cohort 2 ≥ 2 to <6 years of ageExperimental Treatment1 Intervention
ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age
Group V: ZTI-01 Cohort 1 ≥ 6 to <12 years of ageExperimental Treatment1 Intervention
ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age

Find a Location

Who is running the clinical trial?

Nabriva Therapeutics AGLead Sponsor
9 Previous Clinical Trials
2,060 Total Patients Enrolled
John S Bradley, MDPrincipal InvestigatorRady Children's Hospital / Department of Pediatrics, University of California, School of Medicine
Jennifer Schranz, MDStudy ChairNabriva Therapeutics
1 Previous Clinical Trials
551 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental research the inaugural of its kind?

"Currently, 6 trials of the ZTI-01 100 mg/kg drug exist in 14 cities and 5 countries. The original evaluation was completed by Nabriva Therapeutics AG back in 2018; 21 patients participated in Phase 1 of the trial before it received approval from authorities. Since then, 22 finished studies have been logged."

Answered by AI

How many research centers are engaged with this experimental trial?

"The current recruitment efforts are focusing on 5 major medical centres, such as the Kosair Charities Pediatric Clinical Research Unit in Louisville and the Children's Hospital of Michigan in Detroit. Two other sites located in Orange County and multiple additional locations have also opened enrollment for this trial."

Answered by AI

What other research endeavors have employed ZTI-01 100 mg/kg?

"Presently, there are six live clinical trials assessing the efficacy of ZTI-01 100 mg/kg. Technically, none of these investigations have advanced to Phase 3 yet; nevertheless they are conducted in 23 different sites with a majority being located in Albuquerque, New mexico."

Answered by AI

What is the magnitude of individuals participating in this experiment?

"Affirmative, based on the clinicaltrials.gov portal, this medical trial is actively recruiting volunteers. It was first published on May 24th 2018 and last edited on March 3rd 2022; 21 patients are expected to be enrolled in total across 5 sites."

Answered by AI

Is ZTI-01 100 mg/kg capable of providing safe medical benefits for patients?

"Due to the limited data surrounding ZTI-01 100 mg/kg, its safety rating is 1 on a scale from 1 to 3. This assessment is based upon this medication's status as a Phase 1 trial without much prior evidence attesting its efficacy or security."

Answered by AI

Is this experiment currently recruiting participants?

"Affirmative. The clinicaltrials.gov database indicates that the trial, which commenced on May 24th 2018, is currently accepting recruits. Twenty one individuals are required from 5 medical centres for enrollment in this study."

Answered by AI
~5 spots leftby Dec 2025