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Tests treatment safety and results for Complicated Intra-abdominal Infections (cIAI)
Official title A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
ClinicalTrials.gov ID: NCT06794541
What this study is testing
What is IV Eravacycline 2mg/kg?
IV Eravacycline 2mg/kg is an investigational medicine, being studied as a potential treatment for complicated intra-abdominal infections (ciai).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 17
You may be able to join 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...
- 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).
You likely can't join if
- Patient is considered by the investigator to be unlikely to survive the trial period, and/or has any rapidly progressing disease or immediately...
- 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...
- 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...
See the full eligibility criteria
Who can 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.
- 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...
- 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.
What rules you out
- 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...
- 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 treatment clinical trial with an investigational compound or device within 30 days or \<5 half-lives of the investigational compound (whichever is longer)...
- Patient has immunocompromised condition, including acquired immune deficiency syndrome (AIDS), organ (including bone marrow) transplant recipients, and hematologic malignancy, or receiving immunosuppressive therapy...
- 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...
- 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...
- 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...
- Patient has any other circumstance that, in the opinion of the investigator, precludes the patient's participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- Chicago, Illinois, United States
- Shreveport, Louisiana, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; Chicago, Illinois, United States; Shreveport, Louisiana, United States; Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.