A Safety and PK Study of IV Eravacycline

Completed · Phase 1

Conditions studied: Bacterial Infections

In brief

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.

Key facts

Study ID

NCT03696550

Run by

Tetraphase Pharmaceuticals, Inc

People needed

19

Starts

2018-12-20

Expected to finish

2021-03-19

Last updated by the study team

2021-12-03

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Ronald Reagan University of California Los Angeles Medical Center — Los Angeles, California, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• West Virginia University Hospital — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.