A Safety and PK Study of IV Eravacycline

• Status: Unknown status
• Trial end date: 2020-11-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tetraphase Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Male or female from 8 to <18 years of age on the day informed consent (and assent, if applicable) is obtained

2. Written informed consent from parent(s) or other legally authorized representative(s) and informed assent from subject (if age appropriate according to local requirements)

3. 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

4. Likely to survive the current illness

5. In the Investigator's opinion, the subject will require hospitalization for at least 24 hours following administration of the study drug

6. The subject appears to have sufficient intravascular access (peripheral or central) to receive study drug

Exclusion Criteria:

1. Male or female from 8 to <18 years of age on the day informed consent (and assent, if applicable) is obtained

2. Written informed consent from parent(s) or other legally authorized representative(s) and informed assent from subject (if age appropriate according to local requirements)

3. 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

4. Likely to survive the current illness

5. In the Investigator's opinion, the subject will require hospitalization for at least 24 hours following administration of the study drug

6. The subject appears to have sufficient intravascular access (peripheral or central) to receive study drug

7. 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

8. Breastfeeding females

9. 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

10. Positive pregnancy test in females of childbearing potential

11. Any other circumstance that, in the opinion of the Investigator, would preclude subject participation in the study