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Pharmacokinetic and Safety Study of Metronidazole Oral Suspension in Pediatric Patients With Anaerobic Bacterial Infection

NCT07146217 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-28

No results posted yet for this study

Summary

This is an open-label, single-arm, pharmacokinetic and safety study of Likmez® in pediatric patients aged 12 months to \<4 years with anaerobic bacterial infection

Conditions

Interventions

DRUG

Likmez® (metronidazole) Oral Suspension

Each patient will receive 7.5 mg/kg of Likmez® every 6 hours, with a concentration of 100 mg metronidazole/mL

Sponsors & Collaborators

  • CBCC Global Research

    collaborator NETWORK

  • Saptalis Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Polireddy Dondeti, PhD · President & CEO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-07-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07146217 on ClinicalTrials.gov