NCT07146217

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

An Open-Label, Single-Arm, Pharmacokinetic and Safety Study of Likmez® (Metronidazole Oral Suspension) in Pediatric Patients Aged 12 Months to <4 Years With Anaerobic Bacterial Infection

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Saptalis Pharmaceuticals LLC · Industry
• Sex: All
• Age: 12 Months – 4 Years
• Healthy volunteers: Not accepted

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

• Bacterial Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study