Complicated Intra-abdominal Infections (cIAI)Phase 2NCT06794541
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
A Phase 2 study testing IV Eravacycline 2mg/kg and IV Eravacycline 1.5mg/kg in people with Complicated Intra-abdominal Infections (cIAI), run by Tetraphase Pharmaceuticals, Inc at 5 sites in United States.
Trial summary
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to <18 years with cIAI. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Complicated Intra-abdominal Infections (cIAI)
- What is being tested?
- IV Eravacycline 2mg/kg and IV Eravacycline 1.5mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 May 2025to 19 Mar 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
- OR
- 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.
Who cannot join
- 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.
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- 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.
- Patient has received any tetracycline within 14 days of screening.
- 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)
- Patient is currently using or anticipates use of anticoagulant therapy during the treatment period.
- Patient is unable or unwilling, in the opinion of the investigator, to comply with the protocol.
- Patients who are known to be pregnant (positive pregnancy test) and/or breastfeeding at the time of screening.
- 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.
- Patient has any other circumstance that, in the opinion of the investigator, precludes the patient's participation in the trial.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, 90095
- Recruiting
West Virginia University Medicine Children's Hospital
Morgantown, West Virginia, 26506
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
- Recruiting
Children's Hospital of LSU Health Sciences Center Shreveport
Shreveport, Louisiana, 71101
About this study
Official title: 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.
- Being tested
- IV Eravacycline 2mg/kg, IV Eravacycline 1.5mg/kg
- Keywords
- Complicated Intra-abdominal Infections, cIAI, eravacycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Eravacycline 2mg/kgDrug
infused over a 60-minute period
IV Eravacycline 1.5mg/kgDrug
infused over a 60-minute period
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Eravacycline intravenous (IV) will be administered every 12 hours for participants 12 to <18 years of age Receives: 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 Receives: 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 Receives: Drug: IV Eravacycline 2mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Adverse Events (AEs) from the first dose of any amount of eravacycline
Measured: 28 days
Change from baseline values over time in electrocardiogram (ECG) QT measurements
Measured: Day 28
Change from baseline values over time in diastolic blood pressure
Measured: Day 28
Change from baseline values over time in systolic blood pressure
Measured: Day 28
Change from baseline values over time in liver function tests assessed by Comprehensive Metabolic Panel (CMP)
Measured: Day 28
Change from baseline values over time of hemoglobin
Measured: Day 28
Change from baseline values over time in white blood count
Measured: Day 28
Change from baseline values over time in platelets
Measured: Day 28
Change from baseline values over time in kidney function assessed by CMP
Measured: Day 28
Secondary outcomes (2)
Steady state area under the curve (AUC (0-24)) of eravacycline
Measured: Dose cycle 4
Steady state maximum concentration (Cmax) of eravacycline
Measured: Dose cycle 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start22 May 2025
- Primary completion17 Feb 2029 (estimated)
- Study completion19 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Intra-abdominal Infections (cIAI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tetraphase Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innoviva Specialty Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794541
- Sponsor's protocol ID
- CS434-2023-001
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes