21 Participants Needed

Single-Dose ZTI-01 for Pediatric Patients

(Pediatric_PK Trial)

Recruiting at 4 trial locations
SG
Overseen BySteve Gelone
Age: < 18
Sex: Any
Trial Phase: Phase 1
Sponsor: Nabriva Therapeutics AG
Must be taking: Antibiotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be receiving standard antibiotics for a bacterial infection to participate.

Is ZTI-01 (fosfomycin for injection) safe for use in humans?

ZTI-01 (fosfomycin for injection) has been used in many countries outside the USA since the 1970s for treating various infections, suggesting a history of use in humans. However, specific safety data for pediatric patients or for conditions other than complicated urinary tract infections and acute pyelonephritis is not detailed in the provided research articles.12345

How is the drug ZTI-01 different from other treatments for pediatric patients?

ZTI-01, or fosfomycin for injection, is unique because it is administered as a single-dose intravenous treatment, which can be more convenient and potentially improve adherence compared to multi-dose regimens. This is particularly beneficial for pediatric patients who may have difficulty with frequent dosing.678910

What is the purpose of this trial?

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).

Research Team

JS

John S Bradley, MD

Principal Investigator

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

JS

Jennifer Schranz, MD

Principal Investigator

Nabriva Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

Has sufficient intravascular access to receive study drug through peripheral or central line
Signed consent/assent
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
See 2 more

Exclusion Criteria

I have not been in this trial or taken ZTI-01 or fosfomycin in the last 30 days.
I have surgery planned during the time my blood will be tested for fosfomycin levels.
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
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single, weight-adjusted dose of ZTI-01 via continuous IV infusion or syringe pump over a 1-hour period

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics, including blood collection for fosfomycin concentration measurement and assessment of adverse events

1 day
1 visit (in-person)

Treatment Details

Interventions

  • ZTI-01
Trial Overview 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.
Participant Groups
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

ZTI-01 is already approved in United States for the following indications:

🇺🇸
Approved in United States as ZTI-01 for:
  • Complicated urinary tract infections (cUTI)
  • Acute pyelonephritis (AP)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nabriva Therapeutics AG

Lead Sponsor

Trials
10
Recruited
2,100+

Findings from Research

Fosfomycin for injection demonstrated physical compatibility with 77% of the 95 intravenous drugs tested, indicating it can be safely co-administered with many other medications in clinical settings.
However, 22 drugs were found to be incompatible with fosfomycin in at least one of the two diluents tested (0.9% sodium chloride and 5% dextrose), highlighting the need for careful consideration when combining treatments.
Physical compatibility of fosfomycin for injection with select i.v. drugs during simulated Y-site administration.Monogue, ML., Almarzoky Abuhussain, SS., Kuti, JL., et al.[2019]
Fosfomycin, a bactericidal antibiotic that has been used since the 1970s, is being developed for intravenous use in the USA to combat drug-resistant bacteria, particularly for complicated urinary tract infections and acute pyelonephritis.
The review highlights the importance of introducing intravenous fosfomycin (ZTI-01) in the US market as a necessary option to address the growing challenge of antibiotic resistance.
ZTI-01 (fosfomycin for injection) in the treatment of hospitalized patients with complicated urinary tract infections.Burgos, RM., Rodvold, KA.[2019]
Fosfomycin (ZTI-01) shows effective activity against drug-resistant bacteria, including ESBL-producing and carbapenem-resistant strains, in a murine thigh infection model, indicating its potential for treating serious infections.
The study identified that the pharmacokinetic/pharmacodynamic (PK/PD) index, specifically the AUC/MIC ratio, is crucial for determining the efficacy of fosfomycin, with optimal ratios linked to both bacterial stasis and survival in infected mice.
In Vivo Pharmacokinetics and Pharmacodynamics of ZTI-01 (Fosfomycin for Injection) in the Neutropenic Murine Thigh Infection Model against Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.Lepak, AJ., Zhao, M., VanScoy, B., et al.[2020]

References

Physical compatibility of fosfomycin for injection with select i.v. drugs during simulated Y-site administration. [2019]
ZTI-01 (fosfomycin for injection) in the treatment of hospitalized patients with complicated urinary tract infections. [2019]
In Vivo Pharmacokinetics and Pharmacodynamics of ZTI-01 (Fosfomycin for Injection) in the Neutropenic Murine Thigh Infection Model against Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa. [2020]
Exploration of the Pharmacokinetic-Pharmacodynamic Relationships for Fosfomycin Efficacy Using an In Vitro Infection Model. [2018]
Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial. [2020]
Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients. [2022]
Efficacy and safety of antifungals in pediatric patients. [2019]
Mycoses in pediatric patients. [2006]
Dosing considerations in the pediatric patient. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Antifungal prophylaxis in pediatric patients undergoing therapy for cancer: drugs and dosing. [2015]
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