Pediatric ALLPhase 1Pediatric_PKNCT03709914
PK Study of Single-Dose ZTI-01 in Children (<12 Years of Age)
A Phase 1 study testing ZTI-01 100 mg/kg and ZTI-01 75 mg/kg in people with Pediatric ALL, run by Nabriva Therapeutics AG at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- ZTI-01 100 mg/kg and ZTI-01 75 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 May 2018to 10 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
- Recruiting
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
- Recruiting
Rady Children's Hospital
San Diego, California, 92123
About this study
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)
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).
Read the 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.
- Conditions
- Pediatric ALL
- Being tested
- ZTI-01 100 mg/kg, ZTI-01 75 mg/kg
- Keywords
- Pediatric PK
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZTI-01 100 mg/kgDrug
Also called IV fosfomycin, fosfomycin disodium, fosfomycin for injection
ZTI-01 intravenous (IV)
ZTI-01 75 mg/kgDrug
Also called IV fosfomycin, fosfomycin disodium, fosfomycin for injection
ZTI-01 intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| ZTI-01 Cohort 1 ≥ 6 to <12 years of age | Experimental | ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age Receives: Drug: ZTI-01 100 mg/kg |
| ZTI-01 Cohort 2 ≥ 2 to <6 years of age | Experimental | ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age Receives: Drug: ZTI-01 100 mg/kg |
| ZTI-01 Cohort 3a Birth to < 3 mos of age | Experimental | ZTI-01 (fosfomycin IV) 75 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age Receives: Drug: ZTI-01 75 mg/kg |
| ZTI-01 Cohort 3b ≥ 3 to < 6 mos of age | Experimental | ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age Receives: Drug: ZTI-01 100 mg/kg |
| ZTI-01 Cohort 3c ≥ 6 to < 24 mos of age | Experimental | ZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age Receives: Drug: ZTI-01 100 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve (AUC) after a single dose of ZTI-01
By age cohort, determine the ZTI-01 pharmacokinetic area under the plasma concentration-time curve
Measured: From time end of 1-hour infusion on Day 1, up to 8-12 hours post infusion on Day 1
Secondary outcomes (2)
Safety: Treatment Emergent Adverse Events (TEAE)
Number and Incidence of TEAEs by age cohort
Measured: Baseline (start of dosing) through end of study follow-up (Day 2)
Maximum concentration (Cmax) after a single dose of ZTI-01
By age cohort, determine the ZTI-01 pharmacokinetic maximum concentration (Cmax)
Measured: From time end of 1-hour infusion on Day 1, up to 8-12 hours post infusion on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start24 May 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- multiple-center, non-comparative, open-label, PK study
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nabriva Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John S Bradley, MD, Principal investigator, Rady Children's Hospital / Department of Pediatrics, University of California, School of MedicineJennifer Schranz, MD, Study chair, Nabriva Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709914
- Sponsor's protocol ID
- ZTI-01-100
- Acronym
- Pediatric_PK
- Status last verified
- Sep 2023
- First submitted
- 10 Oct 2018
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03709914
- Acronym / sponsor ID
- Pediatric_PK / ZTI-01-100
- Conditions
- Pediatric ALL
- Keywords
- Pediatric PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Nabriva Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 24 May 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- multiple-center, non-comparative, open-label, PK study
| Arm | Type | Receives |
|---|---|---|
| ZTI-01 Cohort 1 ≥ 6 to <12 years of age | Experimental | Drug: ZTI-01 100 mg/kgZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age |
| ZTI-01 Cohort 2 ≥ 2 to <6 years of age | Experimental | Drug: ZTI-01 100 mg/kgZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age |
| ZTI-01 Cohort 3a Birth to < 3 mos of age | Experimental | Drug: ZTI-01 75 mg/kgZTI-01 (fosfomycin IV) 75 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age |
| ZTI-01 Cohort 3b ≥ 3 to < 6 mos of age | Experimental | Drug: ZTI-01 100 mg/kgZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age |
| ZTI-01 Cohort 3c ≥ 6 to < 24 mos of age | Experimental | Drug: ZTI-01 100 mg/kgZTI-01 (fosfomycin IV) 100 mg/kg (single dose) Subjects weighing within the 3rd to < 97th percentile for age |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZTI-01 100 mg/kgAlso: IV fosfomycin, fosfomycin disodium, fosfomycin for injectionZTI-01 intravenous (IV) | Drug | ZTI-01 Cohort 1 ≥ 6 to <12 years of age, ZTI-01 Cohort 2 ≥ 2 to <6 years of age, ZTI-01 Cohort 3b ≥ 3 to < 6 mos of age, ZTI-01 Cohort 3c ≥ 6 to < 24 mos of age |
| ZTI-01 75 mg/kgAlso: IV fosfomycin, fosfomycin disodium, fosfomycin for injectionZTI-01 intravenous (IV) | Drug | ZTI-01 Cohort 3a Birth to < 3 mos of age |
Primary outcome
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
2 secondary outcomes
Safety: Treatment Emergent Adverse Events (TEAE)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Pediatric ALL
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZTI-01 100 mg/kg and ZTI-01 75 mg/kg in people with Pediatric ALL, run by Nabriva Therapeutics AG at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Gelone (6108166641, Steve.Gelone@nabriva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.