RecruitingComplicated Intra-abdominal Infections (cIAI)
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
Eligible age
8–17 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.
Sponsor: Tetraphase Pharmaceuticals, Inc
You may qualify if…
- ✓ 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 one or more systemic signs or symptoms that accompany cIAI, such as fever, leukocytosis, hypotension, abdominal pain, nausea/vomiting, anorexia, abdominal mass on clinical examination, or altered mental status
- ✓ 3. Written informed consent from parent(s) or other legally authorized representative(s) and assent (according to local requirements).
You may not qualify if…
- ✕ 1. Patient is considered by the investigator to be unlikely to survive the trial period, and/or has any rapidly progressing disease or immediately life-threatening illness.
- ✕ 2. Patient's laboratory test results reveal alanine aminotransferase or aspartate transaminase \>5×upper limit of normal range (ULN).
- ✕ 3. Patient's laboratory test results reveal total bilirubin \>2×ULN, unless isolated hyperbilirubinemia is directly related to the acute process.
- ✕ 4. Patient requires peritoneal dialysis, hemodialysis, or hemofiltration at screening. Patient has an estimated glomerular filtration rate (eGFR) \<50 mL/minute/1.73 m².
- ✕ 5. Patient has previously received eravacycline or have enrolled previously in the current trial and been discontinued.
- ✕ 6. Patient has evidence or history of a clinically significant medical condition that may, in the opinion of the investigator, impair trial participation or pose a significant safety risk or diminish the patient's availability to undergo all trial procedures and assessments.
- ✕ 7. Patient is likely to require more than 14 days of treatment with eravacycline, in the opinion of the investigator.
- ✕ 8. Patient is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days or \<5 half-lives of the investigational compound (whichever is longer) prior to screening.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06794541 · last updated 2026-05-05