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
Saptalis Pharmaceuticals LLC
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
Eligibility
- Age range
- 1–4 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Clinical diagnosis with suspected or culture-confirmed anaerobic bacterial infection with pathogens known to be sensitive to metronidazole and requiring treatment for any of the below mentioned infections: 1. Septicaemia and Bacteraemia 2. Intra-abdominal infections (including peritonitis, intra-abdominal abscess, and liver abscess) 3. Bone and joint infections (inclu…
Interventions
- DrugLikmez® (metronidazole) Oral Suspension
Each patient will receive 7.5 mg/kg of Likmez® every 6 hours, with a concentration of 100 mg metronidazole/mL
Locations (3)
- Bioresearch PartnerMiami, Florida
- Empire Medical Clinical TrialsMiami, Florida
- Aavon Clinical TrialsRichmond, Texas