A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 1… (NCT06794541) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
United States35 participantsStarted 2025-05-22
Plain-language summary
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.
Who can participate
Age range8 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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.
What they're measuring
1
Proportion of patients with Adverse Events (AEs) from the first dose of any amount of eravacycline
Timeframe: 28 days
2
Change from baseline values over time in electrocardiogram (ECG) QT measurements
Timeframe: Day 28
3
Change from baseline values over time in diastolic blood pressure
Timeframe: Day 28
4
Change from baseline values over time in systolic blood pressure
Timeframe: Day 28
5
Change from baseline values over time in liver function tests assessed by Comprehensive Metabolic Panel (CMP)
Timeframe: Day 28
6
Change from baseline values over time of hemoglobin
Timeframe: Day 28
7
Change from baseline values over time in white blood count
Timeframe: Day 28
8
Change from baseline values over time in platelets
✕. 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.
9
Change from baseline values over time in kidney function assessed by CMP