35 Participants Needed

Eravacycline for Intra-abdominal Infections

Recruiting at 3 trial locations
IC
Overseen ByISTX Clinical Trials
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Research shows that Eravacycline is effective for treating complicated intra-abdominal infections, with clinical cure rates similar to other antibiotics like ertapenem and meropenem. It is well tolerated and works against a wide range of bacteria, including those resistant to other treatments.12345

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

I can receive medication through my veins.
I meet the criteria for surgery-related enrollment.
I have signs of an unusual immune response for my age.
See 4 more

Exclusion Criteria

I have a history of specific medications or clinical trial participation.
My infection is resistant to eravacycline.
My condition is stable and not immediately life-threatening.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Eravacycline intravenous formulation administered as a single 60-minute IV infusion

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Experimental: Cohort 2bExperimental Treatment1 Intervention
Eravacycline intravenous formulation will be administered as a single 60-minute IV infusion for participants aged 8 to \<10 years of age
Group II: Experimental: Cohort 2aExperimental Treatment1 Intervention
Eravacycline intravenous formulation will be administered as a single 60-minute IV infusion for participants 10 to \<12 years of age
Group III: Experimental: Cohort 1Experimental Treatment1 Intervention
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?

Innoviva Specialty Therapeutics

Lead Sponsor

Trials
3
Recruited
180+

Tetraphase Pharmaceuticals, Inc.

Industry Sponsor

Trials
16
Recruited
3,700+

References

In vitro activity of eravacycline against common ribotypes of Clostridioides difficile. [2021]
Eravacycline: a new treatment option for complicated intra-abdominal infections in the age of multidrug resistance. [2020]
The Efficacy and Safety of Eravacycline in the Treatment of Complicated Intra-Abdominal Infections: A Systemic Review and Meta-Analysis of Randomized Controlled Trials. [2020]
Efficacy and safety of eravacycline: A meta-analysis. [2021]
Eravacycline, a newly approved fluorocycline. [2020]
Eravacycline for the treatment of complicated intra-abdominal infections. [2020]
The efficacy and safety of eravacycline compared with current clinically common antibiotics in the treatment of adults with complicated intra-abdominal infections: A Bayesian network meta-analysis. [2022]
Eravacycline: The Tetracyclines Strike Back. [2020]
A retrospective, multicentre evaluation of eravacycline utilisation in community and academic hospitals. [2022]
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