Bacterial InfectionsPhase 2NCT07146217
Pharmacokinetic and Safety Study of Metronidazole Oral Suspension in Pediatric Patients With Anaerobic Bacterial Infection
A Phase 2 study testing Likmez® (metronidazole) Oral Suspension in people with Bacterial Infections, run by Saptalis Pharmaceuticals LLC at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 months to 4 years
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Likmez® (metronidazole) Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2025to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- Septicaemia and Bacteraemia
- Intra-abdominal infections (including peritonitis, intra-abdominal abscess, and liver abscess)
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- Bone and joint infections (including osteomyelitis)
- 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.
- Parents/legal guardians of the patient have provided Written Informed Consent prior to initiation of any protocol-specific procedures.
Who cannot join
- 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:
- Aspartate aminotransferase (AST), alanine transaminase (ALT)>2 X the upper limit of the reference range
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- WBC count <3.0 X 109 /L
- Total bilirubin ≥20 μmol/L (1.17 mg/dL); except in patients with isolated elevation of indirect bilirubin relating to Gilbert syndrome
- 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)
- Hemoglobin <8 g/dL
- Platelets <100,000/μL
- History or presence of any clinically significant disease or disorder that, in the opinion of the investigator, would put the patient at risk or would potentially influence the results of the study (e.g. evidence of gastrointestinal, hepatic, or renal disease that could affect absorption, distribution, metabolism, or excretion of the orally administered study drug).
- Patients with a history of hereditary fructose intolerance (HFI) or rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
- Patients with a known sensitivity to glucose (e.g. patients with a diagnosis of diabetes or patients taking a ketogenic diet).
- Patients with a history of Severe cutaneous adverse reactions (SCARs), including Stevens Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
- Patients who have used disulfiram within the last two weeks prior to enrollment in study.
- Patients who have consumed products containing propylene glycol within a week prior to enrollment in study and who wish to continue products containing propylene glycol during the study and for at least three days after the end of treatment period.
- Patients with known status of Cockayne syndrome.
- Patients with treatment with any another drug that is known to have pharmacokinetic interaction [For example: barbiturates such as phenytoin or phenobarbital] with metronidazole, within 30 days prior to enrollment or within 5.5 half-lives of the drug, (whichever is longer), until the end of study.
- Previous exposure to metronidazole within 30 days of enrollment.
- Patients with a known history of Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human immunodeficiency virus (HIV), and latent tuberculosis (TB) infections.
- Previous participation in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Bioresearch Partner
Miami, Florida, 33155
Tania Franco, 307-206-5889, tfranco@bioresearchpartner.com
Suzelle Costales, scostales@bioresearchpartner.com
Empire Medical Clinical Trials
Miami, Florida, 33183
Estrada Nailan, (786) 667-1617, Nailan.e@empireclinicaltrials.com
Yovanny Blanco, Yovannu.b@empireclinicaltrial.com
Aavon Clinical Trials
Richmond, Texas, 77407
Zitiali Alanis, 713-282-5600, azitiali@aavonclinical.com
Prashant Zanzane, zprashant@aavonclinical.com
About this study
Official title: 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
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
- Conditions
- Bacterial Infections
- Being tested
- Likmez® (metronidazole) Oral Suspension
- Keywords
- Anaerobic Bacterial Infection
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Likmez® (metronidazole) Oral SuspensionDrug
Each patient will receive 7.5 mg/kg of Likmez® every 6 hours, with a concentration of 100 mg metronidazole/mL
| Study group | Role | What they receive |
|---|---|---|
| Likmez® (metronidazole) Oral Suspension | Experimental | Not described Receives: Drug: Likmez® (metronidazole) Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration [Cmax]
Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Cmax
Measured: 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
Time to reach at maximum plasma concentration [Tmax]
Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Tmax
Measured: 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
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
Measured: 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
Volume of distribution [Vd/F]
Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Vd/F
Measured: 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
Apparent clearance of drug from plasma [CLTotal/F]
Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by CLTotal/F. The CLTotal will be calculated by dividing the dose by the AUC for the given dosing interval [Dose/ AUC0-Tau]
Measured: 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 (14)
Comparison of AUC0-t in Pediatric Patients Without Prior IV Metronidazole to Adult Single-Dose PK Data
Measured: 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
Comparison of Cmax in Pediatric Patients Without Prior IV Metronidazole to Adult Single-Dose PK Data
Measured: 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
Comparison of AUC0-t in Pediatric Patients With Prior IV Metronidazole to Adult Steady-State PK Data
Measured: 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
Comparison of Cmax in Pediatric Patients With Prior IV Metronidazole to Adult Steady-State PK Data
Measured: 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
Number of Participants With Adverse Events as Assessed by CTCAE v5.0
Measured: From screening to end of study, up to 26 days
Number of Participants with Changes in Systolic Blood Pressure and Diastolic Blood Pressure
Measured: From screening to end of study, up to 26 days
Number of Participants with Changes in Respiratory Rate
Measured: From screening to end of study, up to 26 days
Number of Participants with Changes in Pulse Rate
Measured: From screening to end of study, up to 26 days
Number of Participants with Changes in Body Temperature
Measured: From screening to end of study, up to 26 days
Number of Participants with Changes of P wave in Electrocardiogram (ECG)
Measured: From screening to end of study, up to 26 days
Number of Participants with Changes of QRS complex in Electrocardiogram (ECG)
Measured: From screening to end of study, up to 26 days
Number of Participants with Changes of T wave in Electrocardiogram (ECG)
Measured: From screening to end of study, up to 26 days
Number of Participants with Changes in Clinical Laboratory Values
Measured: From screening to end of study, up to 26 days
Number of Participants With Abnormal Physical Examination Findings
Measured: From screening to end of study, up to 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saptalis Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Responsible party
- Sponsor
- Investigators
- Polireddy Dondeti, PhD, Study chair, President & CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146217
- Sponsor's protocol ID
- ATI-1501-0X
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07146217
- Acronym / sponsor ID
- ATI-1501-0X
- Conditions
- Bacterial Infections
- Keywords
- Anaerobic Bacterial Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Saptalis Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Likmez® (metronidazole) Oral Suspension | Experimental | Drug: Likmez® (metronidazole) Oral Suspension |
Who may qualify
- Ages
- 12 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Likmez® (metronidazole) Oral SuspensionEach patient will receive 7.5 mg/kg of Likmez® every 6 hours, with a concentration of 100 mg metronidazole/mL | Drug | Likmez® (metronidazole) Oral Suspension |
Primary outcome
Maximum plasma concentration [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
Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Cmax
Time to reach at maximum plasma concentration [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
Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Tmax
Area under the concentration-time curve from time 0 to time 't' '[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
Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by AUC0-t
Volume of distribution [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
Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by Vd/F
Apparent clearance of drug from plasma [CLTotal/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
Pharmacokinetic profile of metronidazole and hydroxy-metronidazole (primary metabolite) measured by CLTotal/F. The CLTotal will be calculated by dividing the dose by the AUC for the given dosing interval [Dose/ AUC0-Tau]
14 secondary outcomes
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
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
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
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
Number of Participants With Adverse Events as Assessed by CTCAE v5.0
Time frame: From screening to end of study, up to 26 days
Number of Participants with Changes in Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: From screening to end of study, up to 26 days
Number of Participants with Changes in Respiratory Rate
Time frame: From screening to end of study, up to 26 days
Number of Participants with Changes in Pulse Rate
Time frame: From screening to end of study, up to 26 days
Number of Participants with Changes in Body Temperature
Time frame: From screening to end of study, up to 26 days
Number of Participants with Changes of P wave in Electrocardiogram (ECG)
Time frame: From screening to end of study, up to 26 days
Number of Participants with Changes of QRS complex in Electrocardiogram (ECG)
Time frame: From screening to end of study, up to 26 days
Number of Participants with Changes of T wave in Electrocardiogram (ECG)
Time frame: From screening to end of study, up to 26 days
Number of Participants with Changes in Clinical Laboratory Values
Time frame: From screening to end of study, up to 26 days
Number of Participants With Abnormal Physical Examination Findings
Time frame: From screening to end of study, up to 26 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Polireddy Dondeti, PhD study chair
President & CEO
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Likmez® (metronidazole) Oral Suspension in people with Bacterial Infections, run by Saptalis Pharmaceuticals LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Santhy John (631-231-2751 ext. 111, santhy.john@saptalis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration [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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.