A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
Trial Parameters
Brief Summary
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.
Eligibility 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. Cholecystitis with perforation or abscess. 2. Patient has evidence of age-appropriate abnormal systemic inflammatory response syndrome 3. Written informed consent from parent(s) or other legally authorized representative(s) and assent (according to local requirements). 4. In the investigator's opinion, the patient will require hospitalization for at least 4 days. 5. The patient must require hospitalization initially an