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
Sponsors and collaborators
Saptalis Pharmaceuticals LLC
Lead sponsor
CBCC Global Research
Collaborator