A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)

Conditions

• Complicated Intra-abdominal Infections (cIAI)

Eligibility Criteria

Sex

ALL

Age

8 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• IV Eravacycline 2mg/kg — DRUG
  infused over a 60-minute period
• IV Eravacycline 1.5mg/kg — DRUG
  infused over a 60-minute period

Study Details

A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to \<18 years with cIAI.

Key Dates

Start date

May 22, 2025

Status verified

Apr 2026

Primary completion

Feb 17, 2029

Completion

Mar 19, 2029

Study Design

Enrollment

35 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 2b
  Eravacycline IV will be administered every 12 hours for participants aged 8 to \<10 years of age
• Experimental: Cohort 1
  Eravacycline intravenous (IV) will be administered every 12 hours for participants 12 to \<18 years of age
• Experimental: Cohort 2a
  Eravacycline IV will be administered every 12 hours for participants 10 to \<12 years of age

Primary Outcome Measure

Proportion of patients with Adverse Events (AEs) from the first dose of any amount of eravacycline [ Time Frame: 28 days ]

Central Contacts

• ISTX Clinical Trials
  617-715-3600
  [email protected]

Locations (5)

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