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Tetracycline Antibiotic
Eravacycline for Intra-abdominal Infections
Chicago, IL
Phase 2
Waitlist Available
Research Sponsored by Innoviva Specialty Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children from 8 to <18 years of age hospitalized for complicated intra-abdominal infections (cIAI) with specific diagnoses
Patient will require hospitalization for at least 4 days
Must not have
Patient has cIAI caused by eravacycline-resistant pathogen(s)
Patient is unlikely to survive the trial period or has rapidly progressing disease or immediately life-threatening illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial will test the safety and effectiveness of eravacycline in children aged 8 to <18 years with complicated intra-abdominal infections."
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Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for Eravacycline in children aren't listed here, common ones from similar antibiotics include stomach pain, nausea, diarrhea, potential allergic reactions, and changes in liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child, aged 8-17, is hospitalized with a complex belly infection.
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I will be in the hospital for at least 4 days.
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I need to be hospitalized for a serious abdominal infection, requiring antibiotics and surgery.
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I can receive medication through my veins.
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I have signs of an unusual immune response for my age.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My infection is resistant to eravacycline.
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My condition is stable and not immediately life-threatening.
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I am using or plan to use blood thinners during treatment.
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I am sexually active and not using birth control.
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My liver function tests are abnormal.
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I need treatment for my kidney problems.
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I have a condition that weakens my immune system.
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I have a history of specific cancers related to the digestive system.
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I have been treated with specific antibiotics.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 Location
Closest Location:Ann and Robert H Lurie Children's Hospital of Chicago· Chicago, IL· 610 miles
Who is running the clinical trial?
Innoviva Specialty TherapeuticsLead Sponsor
2 Previous Clinical Trials
148 Total Patients Enrolled
Tetraphase Pharmaceuticals, Inc.Industry Sponsor
15 Previous Clinical Trials
3,627 Total Patients Enrolled