Actively Recruiting
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
Led by Tetraphase Pharmaceuticals, Inc · Updated on 2026-05-05
35
Participants Needed
5
Research Sites
199 weeks
Total Duration
On this page
Sponsors
T
Tetraphase Pharmaceuticals, Inc
Lead Sponsor
I
Innoviva Specialty Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 8 to less than 18 years hospitalized for complicated intra-abdominal infection with diagnoses such as intra-abdominal abscess, gastric or intestinal perforation with diffuse peritonitis, peritonitis (not spontaneous bacterial peritonitis), complicated appendicitis, or cholecystitis with perforation or abscess
- Presence of one or more systemic signs or symptoms like fever, leukocytosis, hypotension, abdominal pain, nausea/vomiting, anorexia, abdominal mass, or altered mental status
- Written informed consent from parent(s) or legally authorized representative(s) and assent if applicable
- Expected hospitalization for at least 4 days
- Requires hospitalization and antibacterial therapy for 4 to 14 days plus surgical intervention for current cIAI as judged by the investigator
- Has sufficient intravascular access to receive eravacycline
- Meets either pre-operative enrollment criteria with imaging confirming cIAI and planned surgery within 24 hours, or intra-operative/postoperative enrollment with visual confirmation of cIAI and adequate surgical intervention
You will not qualify if you...
- Unlikely to survive trial period or has rapidly progressing or life-threatening illness
- Alanine aminotransferase or aspartate transaminase levels greater than 5 times upper limit of normal
- Total bilirubin greater than 2 times upper limit of normal unless related to acute process
- Requires peritoneal dialysis, hemodialysis, or hemofiltration; estimated glomerular filtration rate less than 50 mL/min/1.73 m²
- Previously received eravacycline or enrolled and discontinued in this trial
- Medical conditions impairing participation or safety, or limiting availability for trial procedures
- Likely to require more than 14 days of eravacycline treatment
- Participation in another investigational trial within 30 days or less than 5 half-lives of prior investigational compound
- Immunocompromised conditions including AIDS, organ transplant, hematologic malignancy, or immunosuppressive therapy
- Known or suspected inflammatory bowel disease
- Pancreatitis
- Systemic malignancy treated with chemotherapy, immunotherapy, radiation, or antineoplastic therapy within 3 months
- History of hypersensitivity to tetracycline antibiotics
- cIAI caused by pathogens resistant to eravacycline
- Received antibacterial therapy continuously for more than 72 hours prior to screening unless treatment failure
- Received any tetracycline within 14 days prior to screening
- Use of CYP3A inducers or inhibitors within 14 days before screening or expected during treatment (except single moderate or weak inducer dose)
- Current or anticipated use of anticoagulant therapy during treatment
- Unable or unwilling to comply with protocol
- Known pregnancy or breastfeeding at screening
- Sexually active patients of childbearing potential unwilling or unable to use two effective contraception methods or abstain during treatment and 14 days after
- Any other condition that may preclude participation as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
3
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Children's Hospital of LSU Health Sciences Center Shreveport
Shreveport, Louisiana, United States, 71101
Actively Recruiting
5
West Virginia University Medicine Children's Hospital
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
I
ISTX Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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