A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)

Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Intravenous Eravacycline in Pediatric Patients From 8 Years to Less Than 18 Years of Age With Complicated Intra-abdominal Infections (cIAI)

A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to <18 years with cIAI.

Study Overview

• Status: Recruiting
• Conditions: Complicated Intra-abdominal Infections (cIAI)
• Intervention / Treatment: Drug: IV Eravacycline 1.5mg/kg; Drug: IV Eravacycline 2mg/kg

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ISTX Clinical Trials; Phone Number: 617-715-3600; Email: clinicaltrials@istx.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Ronald Reagan University of California Los Angeles Medical Center
    • Orange, California, United States, 92868
      • Recruiting
      • Children's Hospital of Orange County
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann and Robert H Lurie Children's Hospital of Chicago
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Recruiting
      • Children's Hospital of LSU Health Sciences Center Shreveport
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University Medicine Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children from 8 to <18 years of age (as of the day of the informed consent [and assent, if applicable] is obtained), hospitalized for cIAI with one of the following diagnoses:

   1. Intra-abdominal abscess (including hepatic and splenic abscesses).
   2. Gastric or intestinal perforation associated with diffuse peritonitis.
   3. Peritonitis: diffuse infection of the peritoneum (but not spontaneous bacterial peritonitis associated with cirrhosis and chronic ascites).
   4. Appendicitis with perforation, peritonitis, or abscess (complicated appendicitis).
   5. Cholecystitis with perforation or abscess.
2. Patient has one or more systemic signs or symptoms that accompany cIAI, such as fever, leukocytosis, hypotension, abdominal pain, nausea/vomiting, anorexia, abdominal mass on clinical examination, or altered mental status
3. Written informed consent from parent(s) or other legally authorized representative(s) and assent (according to local requirements).
4. In the investigator's opinion, the patient will require hospitalization for at least 4 days.
5. The patient must require hospitalization initially and antibacterial therapy for 4 to 14 days in addition to surgical intervention for the treatment of the current cIAI based on the judgment of the investigator.
6. The patient has sufficient intravascular access (peripheral or central) to receive eravacycline.

7. The patient meets either (A or B) of the following criteria:

   1. Pre-operative enrollment:

      • i. Has a sonogram or radiographic imaging result consistent with the diagnosis of cIAI, and
      • ii. Acute surgical or percutaneous intervention (open laparotomy, laparoscopic surgery, or percutaneous drainage of an abscess) is foreseen within 24 hours.

      OR

   2. Intra-operative/postoperative enrollment:

      • i. Visual confirmation of cIAI (presence of pus within the abdominal cavity), and
      • ii. Surgical intervention includes open laparotomy, laparoscopic surgery, or percutaneous draining of an abscess, and
      • iii. Intervention is considered adequate by the surgical team.

Exclusion Criteria:

1. Patient is considered by the investigator to be unlikely to survive the trial period, and/or has any rapidly progressing disease or immediately life-threatening illness.
2. Patient's laboratory test results reveal alanine aminotransferase or aspartate transaminase >5×upper limit of normal range (ULN).
3. Patient's laboratory test results reveal total bilirubin >2×ULN, unless isolated hyperbilirubinemia is directly related to the acute process.
4. Patient requires peritoneal dialysis, hemodialysis, or hemofiltration at screening. Patient has an estimated glomerular filtration rate (eGFR) <50 mL/minute/1.73 m².
5. Patient has previously received eravacycline or have enrolled previously in the current trial and been discontinued.
6. Patient has evidence or history of a clinically significant medical condition that may, in the opinion of the investigator, impair trial participation or pose a significant safety risk or diminish the patient's availability to undergo all trial procedures and assessments.
7. Patient is likely to require more than 14 days of treatment with eravacycline, in the opinion of the investigator.
8. Patient is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days or <5 half-lives of the investigational compound (whichever is longer) prior to screening.
9. Patient has immunocompromised condition, including acquired immune deficiency syndrome (AIDS), organ (including bone marrow) transplant recipients, and hematologic malignancy, or receiving immunosuppressive therapy, including cancer chemotherapy, medications for prevention of organ transplantation rejection, or chronic administration of systemic corticosteroids (defined as the systemic equivalent of ≥2 mg/kg total daily dose of prednisone for patients ≤20 kg, or >40 mg of prednisone per day for patients >20 kg, administered continuously for more than 14 days in the 30 days prior to the first dose of eravacycline.
10. Patient has known or suspected inflammatory bowel disease.
11. Patient has pancreatitis.
12. Patient has systemic malignancy that required chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the previous 3 months.
13. Patient has history of hypersensitivity or allergic reaction to any tetracycline antibiotics.
14. Patient has cIAI caused by a pathogen(s) resistant to eravacycline at screening.
15. Patient has received antibacterial drug therapy for continuous duration of >72 hours immediately preceding screening unless they are considered treatment failures. Note: Treatment failure is defined as persistent fever and/or clinical symptoms or the development of a new intra-abdominal abscess after ≥72 hours of antibiotic therapy.
16. Patient has received any tetracycline within 14 days of screening.
17. Patient used cytochrome P450 (CYP) 3A inducers or inhibitors within 14 days of screening or is receiving or anticipated to need treatment with CYP3A inducers or inhibitors during the treatment period. (The use of a single dose of a moderate or weak CYP3A inducer used within 14 days prior to screening is allowed)
18. Patient is currently using or anticipates use of anticoagulant therapy during the treatment period.
19. Patient is unable or unwilling, in the opinion of the investigator, to comply with the protocol.
20. Patients who are known to be pregnant (positive pregnancy test) and/or breastfeeding at the time of screening.
21. Sexually active patients of childbearing potential (those with menarche and/or thelarche) who are unwilling or unable to use an acceptable method of contraception (at least 2 medically accepted, effective methods of birth control [e.g., condom, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring]) or sexual abstinence during study treatment and for 14 days after the last dose of study drug.
22. Patient has any other circumstance that, in the opinion of the investigator, precludes the patient's participation in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Eravacycline intravenous (IV) will be administered every 12 hours for participants 12 to <18 years of age	Drug: IV Eravacycline 1.5mg/kg; infused over a 60-minute period
Experimental: Cohort 2a; Eravacycline IV will be administered every 12 hours for participants 10 to <12 years of age	Drug: IV Eravacycline 2mg/kg; infused over a 60-minute period
Experimental: Cohort 2b; Eravacycline IV will be administered every 12 hours for participants aged 8 to <10 years of age	Drug: IV Eravacycline 2mg/kg; infused over a 60-minute period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline values over time of hemoglobin	Day 28
Proportion of patients with Adverse Events (AEs) from the first dose of any amount of eravacycline	28 days
Change from baseline values over time in electrocardiogram (ECG) QT measurements	Day 28
Change from baseline values over time in diastolic blood pressure	Day 28
Change from baseline values over time in systolic blood pressure	Day 28
Change from baseline values over time in liver function tests assessed by Comprehensive Metabolic Panel (CMP)	Day 28
Change from baseline values over time in white blood count	Day 28
Change from baseline values over time in platelets	Day 28
Change from baseline values over time in kidney function assessed by CMP	Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Steady state area under the curve (AUC (0-24)) of eravacycline	Dose cycle 4
Steady state maximum concentration (Cmax) of eravacycline	Dose cycle 4

Collaborators and Investigators

• Sponsor: Tetraphase Pharmaceuticals, Inc
• Collaborators: Innoviva Specialty Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Estimated): February 17, 2029
• Study Completion (Estimated): March 19, 2029

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Complicated Intra-abdominal Infections; cIAI; eravacycline
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Intraabdominal Infections; eravacycline
• Other Study ID Numbers: CS434-2023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data requests may be submitted starting 6 months after primary article publication and the data will be made accessible for up to 24 months; extensions may be considered on a case-by-case basis
• IPD Sharing Access Criteria: Subject to certain criteria, conditions, and exceptions and upon completion of the review and approval of the Research Proposal and Statistical Analysis Plan, Qualified Researchers engaging in independent scientific research can be provided de-identified IPD following the execution of a Data Sharing Agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No