Eravacycline for Intra-abdominal Infections
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications, but certain medications are restricted. You cannot use tetracyclines, certain antibiotics, or medications affecting specific liver enzymes and transporters within 14 days of screening. Please discuss your current medications with the trial team to ensure they are not restricted.
What data supports the effectiveness of the drug Eravacycline for treating complicated intra-abdominal infections?
Is eravacycline safe for human use?
Eravacycline is generally well tolerated in humans, with common side effects including mild reactions at the infusion site, nausea, vomiting, and diarrhea. It has been tested in clinical trials for complicated intra-abdominal infections and showed a good safety profile compared to other antibiotics.12678
How is the drug Eravacycline unique for treating intra-abdominal infections?
Eravacycline is unique because it is a fully synthetic tetracycline derivative that works against a wide range of resistant bacteria, including those that are resistant to other common antibiotics. It is administered intravenously and does not require dose adjustments for kidney function, making it a flexible option for patients with complicated intra-abdominal infections.12579
What is the purpose of this trial?
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.
Eligibility Criteria
This trial is for children aged 8 to 17 who have complicated intra-abdominal infections such as peritonitis or yeast infections within the abdomen. Specific details on inclusion and exclusion criteria are not provided, but typically these would relate to the severity of infection, previous treatment responses, and overall health.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Eravacycline intravenous formulation administered as a single 60-minute IV infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Eravacycline
Find a Clinic Near You
Who Is Running the Clinical Trial?
Innoviva Specialty Therapeutics
Lead Sponsor
Tetraphase Pharmaceuticals, Inc.
Industry Sponsor