Eravacycline for Intra-abdominal Infections

Recruiting at 4 trial locations

Overseen By ISTX Clinical Trials

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Tetraphase Pharmaceuticals, Inc

Must not be taking: Tetracyclines, CYP3A inducers, P-gp inducers, Anticoagulants

Disqualifiers: Immunocompromised, Inflammatory bowel disease, Pancreatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

35 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

Are 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

I can receive medication through my veins.

I meet the criteria for surgery-related enrollment.

Written informed consent from parent(s) or other legally authorized representative(s) and assent

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.

Timeline for a Trial Participant

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

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?

Group I: Experimental: Cohort 2b Experimental Treatment 1 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 2a Experimental Treatment 1 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 1 Experimental Treatment 1 Intervention

Eravacycline intravenous formulation will be administered as a single 60-minute IV infusion for participants 12 to \<18 years of age

Who Is Running the Clinical Trial?

Tetraphase Pharmaceuticals, Inc

Lead Sponsor

Innoviva Specialty Therapeutics

Industry Sponsor

Trials

3

Recruited

180+

Tetraphase Pharmaceuticals, Inc.

Industry Sponsor

Trials

16

Recruited

3,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6617347/

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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01844856

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 ...

3. journals.asm.org journals.asm.org/doi/10.1128/spectrum.02351-23

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 ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1496402/pdf

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 ...

5. academic.oup.com academic.oup.com/cid/article/69/6/921/5250914

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, ...

6. ahdbonline.com ahdbonline.com/articles/2629-pooled-analysis-of-safety-data-from-phase-2-and-3-clinical-trials-evaluating-eravacycline-in-complicated-intra-abdominal-infections

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 ...

7. xerava.com xerava.com/efficacy-and-safety

Efficacy & Safety | XERAVA® (eravacycline) Learn about trial design, clinical response, and safety data for XERAVA® (eravacycline). See Safety Information and Full Prescribing Information.

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1496402/full

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.