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

NCT06794541 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-05

No results posted yet for this study

Summary

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

Conditions

  • Complicated Intra-abdominal Infections (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

Sponsors & Collaborators

  • Innoviva Specialty Therapeutics

    collaborator INDUSTRY

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-22
Primary Completion
2029-02-17
Completion
2029-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794541 on ClinicalTrials.gov