Bacterial InfectionsPhase 1NCT03696550
A Safety and PK Study of IV Eravacycline
A Phase 1 study testing Eravacycline (TP-434) in people with Bacterial Infections, run by Tetraphase Pharmaceuticals, Inc at 7 sites in United States.
Trial summary
This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics and safety of intravenous Eravacycline in Children with Suspected or Confirmed Bacterial Infection. Male and Female subjects from 8 to <18 years of age who fulfill the inclusion/exclusion criteria will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Eravacycline (TP-434)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Dec 2018to 19 Mar 2021
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female from 8 to <18 years of age on the day informed consent (and assent, if applicable) is obtained
- Written informed consent from parent(s) or other legally authorized representative(s) and informed assent from subject (if age appropriate according to local requirements)
- Hospitalized, in stable condition, and receiving or plan to receive within 24 hours systemic antibiotic therapy, other than eravacycline, for a suspected or confirmed bacterial infection
- Likely to survive the current illness
- In the Investigator's opinion, the subject will require hospitalization for at least 24 hours following administration of the study drug
- The subject appears to have sufficient intravascular access (peripheral or central) to receive study drug
Who cannot join
- Evidence or history of a clinically significant medical condition that may, in the assessment of the Investigator, impair study participation or pose a significant safety risk or diminish the subject's ability to undergo all study procedures and assessments
- Received an investigational product and/or device within 30 days prior to study drug administration or is currently enrolled in any other clinical study involving an investigational product or any other type of medical treatment judged by the Investigator, in consultation with the Medical Monitor, not to be scientifically or medically compatible with this study
- History of hypersensitivity to tetracycline antibiotics
- Prior dosing in this protocol
- Unlikely to survive at least 48 hours following administration of study drug
- Unable or unwilling, in the judgment of the Investigator, to comply with the protocol
Show all 11Show fewer
- Subject is a child of an employee of the Investigator or study center who has direct involvement in the proposed study or other studies under the direction of the same Investigator or study center, or an immediate family member of the employee or the Investigator, defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Breastfeeding females
- Females of childbearing potential [those with menarche and/or thelarche (beginning of breast development)] and sexually active males who are unwilling or unable to use an acceptable method of contraception
- Positive pregnancy test in females of childbearing potential
- Any other circumstance that, in the opinion of the Investigator, would preclude subject participation in the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Lurie Children's Hospital
Chicago, Illinois, 60611
University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, 90095
West Virginia University Hospital
Morgantown, West Virginia, 26506
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
About this study
Official title: A Phase 1, Open-label, Multicenter Study to Determine the Pharmacokinetics and Safety of Intravenous Eravacycline in Children With Suspected or Confirmed Bacterial Infection
This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics and safety of intravenous Eravacycline in Children with Suspected or Confirmed Bacterial Infection. Male and Female subjects from 8 to <18 years of age who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Read the detailed description
This is a Phase 1, open-label, single dose study to evaluate PK, safety, and tolerability of IV eravacycline in children with suspected or confirmed bacterial infection who are receiving systemic antibiotic therapy, other than eravacycline. The study design will allow for evaluation of PK and safety of IV eravacycline in a pediatric population at exposures predicted to be comparable to those already studied in adults. The study design is depicted in Figure 1.
Two cohorts defined by age group will be enrolled simultaneously:
- Cohort 1: 12 to <18 years of age (adolescents)
- Cohort 2: 8 to <12 years of age (younger children) Eravacycline will be administered as a single IV dose using the optimum dosage determined from PK-PD modeling and model-based simulations of phase 1, 2, and 3 adult data. Blood samples will be collected for PK analysis at predetermined timepoints.
- Conditions
- Bacterial Infections
- Being tested
- Eravacycline (TP-434)
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eravacycline (TP-434)Drug
Also called Trade name: Xerava™
Subjects will be stratified by age into 2 cohorts, as follows:
- Cohort 1: from 12 to <18 years of age (N=8)
- Cohort 2: from 8 to <12 years of age (N=12 or at least 60% of subjects)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Eravacycline (TP-434) intravenous formulation Eravacycline will be administered as a single 60 minute IV infusion according to age.
Age group (years) Dose (mg/kg) 12 to <18 (Cohort 1) 1.50 Receives: Drug: Eravacycline (TP-434) |
| Cohort 2 | Experimental | Eravacycline will be administered as a single 60 minute IV infusion according to age.
Age group (years) Dose (mg/kg) 8 to <12 (Cohort 2) 1.75 Receives: Drug: Eravacycline (TP-434) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration
Cmax, maximum observed plasma concentration
Measured: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for AUC0-t, area under the plasma concentration-time curve
AUC0-t, area under the plasma concentration
Measured: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
Measured: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
Measured: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life
t1/2, elimination half-life
Measured: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration
Clast, last observed plasma concentration
Measured: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance
CL, systemic clearance
Measured: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution
Vd, volume of distribution
Measured: Screening (-2 to 1) to Day 7
Secondary outcomes (9)
Adverse Events
Assess Adverse Events to assess safety and tolerability
Measured: From the time of signing the informed consent form to Day 7
A Directed Physical examination including chest/respiratory
Changes in Physical examination findings including chest/respiratory
Measured: Screening (-2 to 1) to Day 7.
A Directed Physical examination including heart/cardiovascular
Changes in Physical examination findings including heart/cardiovascular
Measured: Screening (-2 to 1) to Day 7.
Vital Signs including blood pressure
Changes in blood pressure
Measured: Screening (-2 to 1) to Day 7
Vital Signs including heart rate
Changes in heart rate
Measured: Screening (-2 to 1) to Day 7
Vital Signs including respiratory rate
Changes in respiratory rate
Measured: Screening (-2 to 1) to Day 7
Vital Signs including body temperature
Changes in body temperature
Measured: Screening (-2 to 1) to Day 7
Safety laboratory results including clinical chemistry
Changes in Clinical laboratory tests including clinical chemistry
Measured: Screening (-2 to 1) to Day 7
Safety laboratory tests including hematology
Changes in Clinical laboratory tests including hematology
Measured: Screening (-2 to 1) to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start20 Dec 2018
- Primary completion14 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696550
- Sponsor's protocol ID
- TP-434-028
- Status last verified
- Dec 2021
- First submitted
- 26 Sep 2018
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter Study to Determine the Pharmacokinetics and Safety of Intravenous Eravacycline in Children With Suspected or Confirmed Bacterial Infection
- ClinicalTrials.gov ID
- NCT03696550
- Acronym / sponsor ID
- TP-434-028
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Tetraphase Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 4 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.
This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics and safety of intravenous Eravacycline in Children with Suspected or Confirmed Bacterial Infection. Male and Female subjects from 8 to <18 years of age who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Detailed description
This is a Phase 1, open-label, single dose study to evaluate PK, safety, and tolerability of IV eravacycline in children with suspected or confirmed bacterial infection who are receiving systemic antibiotic therapy, other than eravacycline. The study design will allow for evaluation of PK and safety of IV eravacycline in a pediatric population at exposures predicted to be comparable to those already studied in adults. The study design is depicted in Figure 1.
Two cohorts defined by age group will be enrolled simultaneously:
- Cohort 1: 12 to <18 years of age (adolescents)
- Cohort 2: 8 to <12 years of age (younger children) Eravacycline will be administered as a single IV dose using the optimum dosage determined from PK-PD modeling and model-based simulations of phase 1, 2, and 3 adult data. Blood samples will be collected for PK analysis at predetermined timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Eravacycline (TP-434)Eravacycline (TP-434) intravenous formulation Eravacycline will be administered as a single 60 minute IV infusion according to age. Age group (years) Dose (mg/kg) 12 to <18 (Cohort 1) 1.50 |
| Cohort 2 | Experimental | Drug: Eravacycline (TP-434)Eravacycline will be administered as a single 60 minute IV infusion according to age. Age group (years) Dose (mg/kg) 8 to <12 (Cohort 2) 1.75 |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female from 8 to <18 years of age on the day informed consent (and assent, if applicable) is obtained
- Written informed consent from parent(s) or other legally authorized representative(s) and informed assent from subject (if age appropriate according to local requirements)
- Hospitalized, in stable condition, and receiving or plan to receive within 24 hours systemic antibiotic therapy, other than eravacycline, for a suspected or confirmed bacterial infection
- Likely to survive the current illness
- In the Investigator's opinion, the subject will require hospitalization for at least 24 hours following administration of the study drug
Key exclusion criteria (11 listed)
- Evidence or history of a clinically significant medical condition that may, in the assessment of the Investigator, impair study participation or pose a significant safety risk or diminish the subject's ability to undergo all study procedures and assessments
- Received an investigational product and/or device within 30 days prior to study drug administration or is currently enrolled in any other clinical study involving an investigational product or any other type of medical treatment judged by the Investigator, in consultation with the Medical Monitor, not to be scientifically or medically compatible with this study
- History of hypersensitivity to tetracycline antibiotics
- Prior dosing in this protocol
- Unlikely to survive at least 48 hours following administration of study drug
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 |
|---|---|---|
| Eravacycline (TP-434)Also: Trade name: Xerava™Subjects will be stratified by age into 2 cohorts, as follows: * Cohort 1: from 12 to <18 years of age (N=8) * Cohort 2: from 8 to <12 years of age (N=12 or at least 60% of subjects) | Drug | Cohort 1, Cohort 2 |
Primary outcome
Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration
Time frame: Screening (-2 to 1) to Day 7
Cmax, maximum observed plasma concentration
Assess the Pharmacokinetics (PK) parameters for AUC0-t, area under the plasma concentration-time curve
Time frame: Screening (-2 to 1) to Day 7
AUC0-t, area under the plasma concentration
Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
Time frame: Screening (-2 to 1) to Day 7
AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
Time frame: Screening (-2 to 1) to Day 7
AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life
Time frame: Screening (-2 to 1) to Day 7
t1/2, elimination half-life
Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration
Time frame: Screening (-2 to 1) to Day 7
Clast, last observed plasma concentration
Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance
Time frame: Screening (-2 to 1) to Day 7
CL, systemic clearance
Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution
Time frame: Screening (-2 to 1) to Day 7
Vd, volume of distribution
9 secondary outcomes
Adverse Events
Time frame: From the time of signing the informed consent form to Day 7
A Directed Physical examination including chest/respiratory
Time frame: Screening (-2 to 1) to Day 7.
A Directed Physical examination including heart/cardiovascular
Time frame: Screening (-2 to 1) to Day 7.
Vital Signs including blood pressure
Time frame: Screening (-2 to 1) to Day 7
Vital Signs including heart rate
Time frame: Screening (-2 to 1) to Day 7
Vital Signs including respiratory rate
Time frame: Screening (-2 to 1) to Day 7
Vital Signs including body temperature
Time frame: Screening (-2 to 1) to Day 7
Safety laboratory results including clinical chemistry
Time frame: Screening (-2 to 1) to Day 7
Safety laboratory tests including hematology
Time frame: Screening (-2 to 1) to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 Eravacycline (TP-434) in people with Bacterial Infections, run by Tetraphase Pharmaceuticals, Inc at 7 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration (time frame: Screening (-2 to 1) to Day 7). The study lists 8 primary outcomes in all. 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 3 Dec 2021.