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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-4
SponsorSaptalis Pharmaceuticals LLC

About this trial

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

Eligibility criteria

Qualifiers

Age between ≥ 12 months and < 4 years till the time of dosing in the study

Sufficient venous access to permit cannulation for required blood sample collection.

Ability to swallow oral liquids.

Septicaemia and Bacteraemia

Disqualifiers

History of anaphylactic reaction to metronidazole or other nitroimidazole derivatives (e.g., tinidazole).

Presence of clinically significant encephalopathy or peripheral neuropathy.

Presence or history of clinically significant convulsive seizure disorders.

Presence or history of any hematologic condition or blood dyscrasia which may result in leukopenia (even if leukocyte count is normal at screening).

Trial design

Treatments tested in this trial

  • Likmez® (metronidazole) Oral Suspension

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Saptalis Pharmaceuticals LLC

Lead sponsor

CBCC Global Research

Collaborator