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

NCT06794541 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CS434-2023-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Complicated Intra-abdominal Infections (cIAI)

Keywords

Complicated Intra-abdominal Infections; cIAI; eravacycline

Outcome Measures

Primary Outcomes (9)

• 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 of hemoglobin

  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 Outcomes (2)

• Steady state area under the curve (AUC (0-24)) of eravacycline

  Dose cycle 4

• Steady state maximum concentration (Cmax) of eravacycline

  Dose cycle 4

Study Arms (3)

Cohort 1

EXPERIMENTAL

Eravacycline intravenous (IV) will be administered every 12 hours for participants 12 to \<18 years of age

Drug: IV Eravacycline 1.5mg/kg

Cohort 2a

EXPERIMENTAL

Eravacycline IV will be administered every 12 hours for participants 10 to \<12 years of age

Drug: IV Eravacycline 2mg/kg

Cohort 2b

EXPERIMENTAL

Eravacycline IV will be administered every 12 hours for participants aged 8 to \<10 years of age

Drug: IV Eravacycline 2mg/kg

Interventions

IV Eravacycline 2mg/kg DRUG

infused over a 60-minute period

Cohort 2a; Cohort 2b

IV Eravacycline 1.5mg/kg DRUG

infused over a 60-minute period

Cohort 1

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Intra-abdominal abscess (including hepatic and splenic abscesses).
• Gastric or intestinal perforation associated with diffuse peritonitis.
• Peritonitis: diffuse infection of the peritoneum (but not spontaneous bacterial peritonitis associated with cirrhosis and chronic ascites).
• Appendicitis with perforation, peritonitis, or abscess (complicated appendicitis).
• Cholecystitis with perforation or abscess.
• 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
• Written informed consent from parent(s) or other legally authorized representative(s) and assent (according to local requirements).
• In the investigator's opinion, the patient will require hospitalization for at least 4 days.
• 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.
• The patient has sufficient intravascular access (peripheral or central) to receive eravacycline.
• The patient meets either (A or B) of the following criteria:
• 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.

You may not qualify if:

• 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.
• Patient's laboratory test results reveal alanine aminotransferase or aspartate transaminase \>5×upper limit of normal range (ULN).
• Patient's laboratory test results reveal total bilirubin \>2×ULN, unless isolated hyperbilirubinemia is directly related to the acute process.
• Patient requires peritoneal dialysis, hemodialysis, or hemofiltration at screening. Patient has an estimated glomerular filtration rate (eGFR) \<50 mL/minute/1.73 m².
• Patient has previously received eravacycline or have enrolled previously in the current trial and been discontinued.
• 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.
• Patient is likely to require more than 14 days of treatment with eravacycline, in the opinion of the investigator.
• 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.
• 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.
• Patient has known or suspected inflammatory bowel disease.
• Patient has pancreatitis.
• Patient has systemic malignancy that required chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the previous 3 months.
• Patient has history of hypersensitivity or allergic reaction to any tetracycline antibiotics.
• Patient has cIAI caused by a pathogen(s) resistant to eravacycline at screening.
• 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.

Sponsors & Collaborators

• Tetraphase Pharmaceuticals, Inc: lead
• Innoviva Specialty Therapeutics: collaborator

Study Sites (5)

UCLA Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

Ann and Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Children's Hospital of LSU Health Sciences Center Shreveport

Shreveport, Louisiana, 71101, United States

RECRUITING

West Virginia University Medicine Children's Hospital

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Interventions

eravacycline

Central Study Contacts

ISTX Clinical Trials

CONTACT

617-715-3600; clinicaltrials@istx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 27, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): February 17, 2029
• Study Completion (Estimated): March 19, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• 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

Locations

US (5)