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

ConditionBacterial Infections
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Likmez® (metronidazole) Oral Suspension

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Likmez® (metronidazole) Oral SuspensionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum plasma concentration [Cmax]

Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Cmax

Time frame
Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose
2

Time to reach at maximum plasma concentration [Tmax]

Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Tmax

Time frame
Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose
3

Area under the concentration-time curve from time 0 to time 't' '[AUC0-t]

Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by AUC0-t

Time frame
Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose
4

Volume of distribution [Vd/F]

Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Vd/F

Time frame
Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

Secondary outcomes

1

Comparison of AUC0-t in Pediatric Patients Without Prior IV Metronidazole to Adult Single-Dose PK Data

Time frame
Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose
2

Comparison of Cmax in Pediatric Patients Without Prior IV Metronidazole to Adult Single-Dose PK Data

Time frame
Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose
3

Comparison of AUC0-t in Pediatric Patients With Prior IV Metronidazole to Adult Steady-State PK Data

Time frame
Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose
4

Comparison of Cmax in Pediatric Patients With Prior IV Metronidazole to Adult Steady-State PK Data

Time frame
Day 1 at Pre-dose (0.00 hour, within 01 hour prior to dosing) and at 01.00, 02.00, 4.00 and 6.00 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saptalis Pharmaceuticals LLC

Lead sponsor

CBCC Global Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: