NCT06794541 · Tetraphase Pharmaceuticals, Inc
A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
What this study is about
A Phase 2 trial to assess safety, tolerability, and how the drug moves through the body of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.
View original scientific description
A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.
Interventions
DRUG
IV Eravacycline 2mg/kg
infused over a 60-minute period
DRUG
IV Eravacycline 1.5mg/kg
infused over a 60-minute period
Primary outcome measures
Proportion of patients with Adverse Events (AEs) from the first dose of any amount of eravacycline
Time frame: 28 days
Change from baseline values over time in electrocardiogram (ECG) QT measurements
Time frame: Day 28
Change from baseline values over time in diastolic blood pressure
Time frame: Day 28
Change from baseline values over time in systolic blood pressure
Time frame: Day 28
Change from baseline values over time in liver function tests assessed by Comprehensive Metabolic Panel (CMP)
Time frame: Day 28
Change from baseline values over time of hemoglobin
Time frame: Day 28
Change from baseline values over time in white blood count
Time frame: Day 28
Change from baseline values over time in platelets
Time frame: Day 28
Change from baseline values over time in kidney function assessed by CMP
Time frame: Day 28
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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: 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 evidence of age-appropriate abnormal systemic inflammatory response syndrome 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 hospitaliza
Where
- Los Angeles, California
- Orange, California
- Chicago, Illinois
- Shreveport, Louisiana
- Morgantown, West Virginia
Collaborators
Innoviva Specialty Therapeutics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations