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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

NCT07146217•Saptalis Pharmaceuticals LLC

View on ClinicalTrials.gov

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

1 - 4 years

Sex

ALL

Healthy Volunteers

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 (including osteomyelitis)
•4. Lower respiratory tract infections (including pneumonia, empyema, and lung abscess)
•Patients with clinical diagnosis of polymicrobial infection who can be administered Likmez® with other antibacterial agents without clinically significant drug-drug interactions. Note: These patients will be allowed concomitant administration with other antibacterial drugs, not having an interaction with metronidazole (Refer APPENDIX B: List of Antibiotic Drugs Having Interaction with Metronidazole, for the list of antibiotic drugs having interaction with metronidazole). If co-administration of such medications cannot be avoided, PI should consider taking steps to minimize the risk of QT/QTc interval prolongation and torsade de pointes (TdP), such as electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
•Any of the above mentioned clinical conditions, which would allow them to initiate the treatment with IV or oral anti-bacterial drugs with activity against anaerobic bacteria (e.g., IV treatment such as a betalactam/beta-lactamase inhibitor or a cephalosporin plus metronidazole; or oral treatment such as amoxicillin, amoxicillin-clavulanate, or azithromycin) followed by treatment with i.e. Likmez® at 7.5 mg/kg, to complete the treatment course and are able to provide PK samples for the study.
+1 more criteria

Exclusion Criteria

•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).
•Abnormal laboratory results for the following analyses showing any of the following abnormal results:
•1. Aspartate aminotransferase (AST), alanine transaminase (ALT)\>2 X the upper limit of the reference range
•2. WBC count \<3.0 X 109 /L
•3. Total bilirubin ≥20 μmol/L (1.17 mg/dL); except in patients with isolated elevation of indirect bilirubin relating to Gilbert syndrome
•4. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 using the Bedside Schwartz methods for estimation (eGFR = 41.3 x height/serum creatinine (Scr), where height is in meters and Scr in mg/dL)
•5. Hemoglobin \<8 g/dL
+12 more criteria

Locations (3)

Bioresearch Partner

Miami, Florida, United States

Empire Medical Clinical Trials

Miami, Florida, United States

Aavon Clinical Trials

Richmond, Texas, United States

Key Dates

Start Date

August 1, 2025

Primary Completion Date

July 1, 2026

Completion Date

October 1, 2026

Last Updated

August 28, 2025

Enrollment

ESTIMATED participants

Conditions

Bacterial Infections

Interventions

Likmez® (metronidazole) Oral Suspension

DRUG

Contacts

Santhy John

CONTACT

631-231-2751 santhy.john@saptalis.com

Veera Somasani

CONTACT

631-231-2751 veera.somasani@saptalis.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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