Metronidazole for Bacterial Infection

Not yet recruiting at 2 trial locations

Overseen By Veera Somasani

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Saptalis Pharmaceuticals LLC

Must be taking: Antibacterials

Must not be taking: Barbiturates, Disulfiram, others

Disqualifiers: Seizures, Neuropathy, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how Likmez® (metronidazole) works in children with certain bacterial infections. It focuses on those with infections such as pneumonia, bone infections, or abdominal infections requiring antibiotic treatment. The goal is to understand the drug's safety and how it moves through the body. Eligible children have a known bacterial infection and can swallow liquids. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important medical advancements.

Do I need to stop my current medications to join the trial?

The trial allows participants to take other antibacterial drugs that do not interact with metronidazole. However, if you are taking medications that interact with metronidazole, you may need to stop them. Check with the trial team for specific guidance on your medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that metronidazole, the main ingredient in Likmez®, treats bacterial infections in various parts of the body. However, its safety for young children remains uncertain. Studies have found that metronidazole can combat certain bacteria, but it also carries some risks. For instance, it caused cancer in animal studies, so it should only be used when necessary.

Metronidazole may cause side effects such as nausea, dizziness, and headaches in some people. These side effects are usually mild but can still be uncomfortable. This study is in an early stage and aims to learn more about the safety and tolerability of Likmez® for children aged 12 months to under 4 years. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for bacterial infections, which are often available as tablets or injections, Likmez® (metronidazole) is an oral suspension. This liquid form can be particularly beneficial for individuals who have difficulty swallowing pills, such as children or the elderly. Researchers are excited about Likmez® because it offers a potentially more accessible and easier-to-administer option without compromising on effectiveness.

What evidence suggests that this treatment might be an effective treatment for bacterial infection?

Research has shown that metronidazole is an important treatment for infections caused by bacteria that don't need oxygen to grow. It effectively treats various bacterial infections, including those caused by Bacteroides species. One study found that taking metronidazole every 12 hours works just as well as taking it every 8 hours for these infections. This trial will specifically evaluate the safety and effectiveness of the liquid form, Likmez® (metronidazole) Oral Suspension, which has not yet been proven in young children. ^{1 6 7 8 9}

Who Is on the Research Team?

Polireddy Dondeti, PhD

Principal Investigator

President & CEO

Are You a Good Fit for This Trial?

This trial is for young children aged 12 months to less than 4 years who have an infection caused by bacteria that can live without oxygen (anaerobic). Specific eligibility details are not provided, but typically participants must have a confirmed diagnosis and be in stable health.

Inclusion Criteria

I can have blood drawn without difficulty.

I can swallow liquids.

My child is between 1 and 4 years old.

Exclusion Criteria

I have not taken metronidazole in the last 30 days.

I have a history of hepatitis B, hepatitis C, HIV, or latent TB.

History of anaphylactic reaction to metronidazole or other nitroimidazole derivatives (e.g., tinidazole)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Likmez® (metronidazole) oral suspension and undergo pharmacokinetic assessments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Metronidazole

Trial Overview

The study is testing Likmez®, which is a liquid form of metronidazole, to see how it's processed in the body and its safety. It's given to kids with anaerobic bacterial infections. This trial does not compare against other treatments and all participants receive Likmez®.

How Is the Trial Designed?

Group I: Likmez® (metronidazole) Oral Suspension Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Saptalis Pharmaceuticals LLC

Lead Sponsor

Trials

1

Recruited

130+

CBCC Global Research

Collaborator

Trials

8

Recruited

1,300+

Citations

1.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2023/216755s000lbl.pdf

LIKMEZ (metronidazole) - accessdata.fda.gov

The safety and effectiveness of LIKMEZ for the treatment of trichomoniasis and anaerobic bacterial infections have not been established in pediatric patients.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10761045/

A comparison of clinical outcomes associated with dosing ...

This review suggests that dosing metronidazole every 12 hours is as effective as every-8-hour dosing for hospitalized patients with anaerobic infections.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0924857924003194

Clinical outcomes of a twice-daily metronidazole dosing ...

The purpose of this study was to evaluate the efficacy and safety of metronidazole 500 mg twice daily in patients with Bacteroides spp. bacteraemia.

4.

mdpi.com

mdpi.com/2079-6382/14/7/688

Assessing Clinical Outcomes of Metronidazole for Intra ...

In this study, there was no difference in clinical cure between metronidazole dosed q8hr vs. q12hr in patients treated for IAI. These findings support ...

5.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK539728/

Metronidazole - StatPearls - NCBI Bookshelf - NIH

Metronidazole is one of the mainstay drugs for the treatment of anaerobic bacterial infections, protozoal infections, and microaerophilic bacterial infections.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07146217

Pharmacokinetic and Safety Study of Metronidazole Oral ...

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

7.

likmez.com

likmez.com/

LIKMEZ® FDA-Approved Liquid Formulation of Metronidazole

Metronidazole has been shown to be carcinogenic in mice and rats. Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: ...

8.

mayoclinic.org

mayoclinic.org/drugs-supplements/metronidazole-oral-route/description/drg-20064745

Metronidazole (oral route) - Side effects & dosage

Metronidazole is used to treat bacterial infections in different areas of the body. ... Safety and efficacy have not been established. Appropriate studies ...

9.

empr.com

empr.com/drug/likmez/

LIKMEZ Prescription & Dosage Information - MPR

Metronidazole exerts antibacterial effects in an anaerobic environment against most obligate anaerobes. Once metronidazole enters the organism by passive ...