Eravacycline for Intra-abdominal Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new antibiotic, eravacycline, to determine its safety and behavior in the bodies of children with serious abdominal infections. These infections may include conditions like burst appendixes or gallbladders requiring urgent medical treatment. Children aged 8 to under 18, hospitalized for at least four days due to these infections, may qualify for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important medical advancements.
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.
Is there any evidence suggesting that eravacycline is likely to be safe for pediatric patients?
Research has shown that eravacycline is generally safe for adults with complicated intra-abdominal infections (cIAI). A review of safety data found that taking eravacycline every 12 hours was mostly safe. Most side effects were mild to moderate, with some adults experiencing nausea or vomiting, though these were not very common.
Although this trial focuses on younger patients, the safety record in adults offers some reassurance. The data suggests eravacycline is generally safe, but results in children might differ. Discuss any concerns with the trial team.12345Why do researchers think this study treatment might be promising for intra-abdominal infections?
Eravacycline is unique because it offers a new approach to treating intra-abdominal infections, particularly in younger patients. Unlike standard antibiotics like carbapenems, Eravacycline is a tetracycline antibiotic with a novel structure, allowing it to evade common bacterial resistance mechanisms. Its intravenous delivery in a single 60-minute infusion could make it a more convenient and targeted option, especially for pediatric patients. Researchers are excited about its potential to effectively combat resistant bacteria with a streamlined administration process.
What evidence suggests that eravacycline might be an effective treatment for intra-abdominal infections?
Previous studies have shown that eravacycline effectively treats complicated intra-abdominal infections (cIAI) in adults. Research indicates that over 80% of patients treated with eravacycline experienced improvement or disappearance of their infection symptoms. One study found eravacycline to be as effective as the existing antibiotic, meropenem, with similar success rates. The drug effectively targets infections caused by hard-to-treat bacteria, including those producing ESBL, an enzyme that makes bacteria resistant to some antibiotics. These findings suggest that eravacycline could be a promising treatment option for cIAI.
In this trial, participants aged 8 to under 18 will receive eravacycline as a single 60-minute IV infusion to evaluate its effectiveness and safety in younger populations.12678Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Eravacycline
Trial Overview
The study is testing two different doses of a medication called Eravacycline (2mg/kg and 1.5mg/kg) in children with abdominal infections. It's a Phase 2 trial focusing on how safe the drug is, how well it's tolerated by patients, and how it moves through young bodies.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Eravacycline intravenous formulation will be administered as a single 60-minute IV infusion for participants aged 8 to \<10 years of age
Eravacycline intravenous formulation will be administered as a single 60-minute IV infusion for participants 10 to \<12 years of age
Eravacycline intravenous formulation will be administered as a single 60-minute IV infusion for participants 12 to \<18 years of age
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tetraphase Pharmaceuticals, Inc
Lead Sponsor
Innoviva Specialty Therapeutics
Industry Sponsor
Tetraphase Pharmaceuticals, Inc.
Industry Sponsor
Citations
The Efficacy and Safety of Eravacycline in the Treatment ...
This study aims to assess the clinical efficacy and safety of eravacycline for treating complicated intra-abdominal infection (cIAI) in adult patients.
NCT01844856 | Efficacy and Safety Study of Eravacycline ...
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related ...
Eravacycline, the first four years: health outcomes and ...
Infections treated with eravacycline were classified as hospital-acquired in 49.5% (n = 206/416) of cases with a median (IQR) of 3 (1, 14) days ...
Efficacy and safety of eravacycline versus tigecycline for ...
Methods: This is a multicenter, single-blind, parallel randomized controlled trial. Adult patients in the ICU with complex abdominal infections ...
IGNITE4: Results of a Phase 3, Randomized, Multicenter ...
In patients with ESBL-producing Enterobacteriaceae, clinical cure rates were 87.5% (14/16) and 84.6% (11/13) in the eravacycline and meropenem groups, ...
Pooled Analysis of Safety Data from Phase 2 and 3 Clinical ...
Pooled analysis data demonstrated that eravacycline 1 mg/kg every 12 hours is generally well-tolerated for the treatment of complicated intra-abdominal ...
Efficacy & Safety | XERAVA® (eravacycline)
Learn about trial design, clinical response, and safety data for XERAVA® (eravacycline). See Safety Information and Full Prescribing Information.
Efficacy and safety of eravacycline versus tigecycline for ...
This trial will compare eravacycline to tigecycline for treating cIAIs in patients in the ICU, aiming to provide a superior treatment option.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.