Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Intravenous Eravacycline in Pediatric Patients From 8 Years to Less Than 18 Years of Age With Complicated Intra-abdominal Infections (cIAI)

Tetraphase Pharmaceuticals, Inc

Summary

A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.

Eligibility

Age range: 8–17 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Children from 8 to \<18 years of age (as of the day of the informed consent \[and assent, if applicable\] is obtained), hospitalized for cIAI with one of the following diagnoses: 1. Intra-abdominal abscess (including hepatic and splenic abscesses). 2. Gastric or intestinal perforation associated with diffuse peritonitis. 3. Peritonitis: diffuse infection of the peritoneum (but not spontaneous bacterial peritonitis associated with cirrhosis and chronic ascites). 4. Appendicitis with perforation, peritonitis, or abscess (complicated appendicitis). 5. Chole…

Interventions

Drug
IV Eravacycline 2mg/kg
infused over a 60-minute period
Drug
IV Eravacycline 1.5mg/kg
infused over a 60-minute period

Locations (5)

UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California
Children's Hospital of Orange County
Orange, California
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois
Children's Hospital of LSU Health Sciences Center Shreveport
Shreveport, Louisiana
West Virginia University Medicine Children's Hospital
Morgantown, West Virginia