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 range

8 Years – 17 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients with Adverse Events (AEs) from the first dose of any amount of eravacycline

Timeframe: 28 days

Change from baseline values over time in electrocardiogram (ECG) QT measurements

Timeframe: Day 28

Change from baseline values over time in diastolic blood pressure

Timeframe: Day 28

Change from baseline values over time in systolic blood pressure

Timeframe: Day 28

Change from baseline values over time in liver function tests assessed by Comprehensive Metabolic Panel (CMP)

Timeframe: Day 28

Change from baseline values over time of hemoglobin

Timeframe: Day 28

Change from baseline values over time in white blood count

Timeframe: Day 28

Trial details

NCT IDNCT06794541

SponsorTetraphase Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-02-17

Contact for this trial

ISTX Clinical Trials

617-715-3600 clinicaltrials@istx.com

View on ClinicalTrials.gov More Complicated Intra-abdominal Infections (cIAI) trials

Who can participate

Age range

8 Years – 17 Years

Sex

ALL

See this in plain English?

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.

What they're measuring

Proportion of patients with Adverse Events (AEs) from the first dose of any amount of eravacycline

Timeframe: 28 days

Change from baseline values over time in electrocardiogram (ECG) QT measurements

Timeframe: Day 28

Change from baseline values over time in diastolic blood pressure

Timeframe: Day 28

Change from baseline values over time in systolic blood pressure

Timeframe: Day 28

Change from baseline values over time in liver function tests assessed by Comprehensive Metabolic Panel (CMP)

Timeframe: Day 28

Change from baseline values over time of hemoglobin

Timeframe: Day 28

Change from baseline values over time in white blood count

Timeframe: Day 28