A Safety and PK Study of IV Eravacycline (NCT03696550) | Clinical Trial Compass
CompletedPhase 1
A Safety and PK Study of IV Eravacycline
United States19 participantsStarted 2018-12-20
Plain-language 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.
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration
Timeframe: Screening (-2 to 1) to Day 7
2
Assess the Pharmacokinetics (PK) parameters for AUC0-t, area under the plasma concentration-time curve
Timeframe: Screening (-2 to 1) to Day 7
3
Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
Timeframe: Screening (-2 to 1) to Day 7
4
Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
Timeframe: Screening (-2 to 1) to Day 7
5
Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life
Timeframe: Screening (-2 to 1) to Day 7
6
Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration
. 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
. 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
Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance
Timeframe: Screening (-2 to 1) to Day 7
8
Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution