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Penicillin antibiotic

Pediatric patients with a bacterial infection for Bacterial Infection

Phase 1

Recruiting

Research Sponsored by Kaizen Bioscience Co.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female children between 3 months and 24 months of age

Patients recruited from inpatient/urgent care/emergency room with a bacterial infection. Examples of bacterial infections could include acute otitis media, community-acquired pneumonia, aspiration pneumonia, urinary tract infections, lymphadenitis, retropharyngeal abscess, peritonsillar abscess, animal or human bite, cellulitis, skin abscess, or dental infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 hours post dose

Awards & highlights

Study Summary

This trial tests a medicine to see if it's safe & effective for kids with bacterial infections. #medicine #kids #bacterialinfections

Who is the study for?

This trial is for male or female children aged 3 months to 24 months with bacterial infections such as ear, lung, urinary tract infections, abscesses, cellulitis, or dental infection. They must be recruited from inpatient/urgent care/emergency settings and have parental consent. Children with gastrointestinal, liver or kidney diseases; severe allergies to penicillin; immune issues; on steroids; underweight or overweight; younger than 3 months or older than 2 years are excluded.Check my eligibility

What is being tested?

The study tests LP-001's pharmacokinetic profiles—a combination of amoxicillin and clavulanate—in treating pediatric bacterial infections. It aims to understand how the drug moves into, through, and out of young children's bodies.See study design

What are the potential side effects?

Potential side effects may include allergic reactions (if not previously known), digestive problems like diarrhea (especially if caused by Clostridium difficile after antibiotic use), potential liver issues like jaundice associated with amoxicillin clavulanate use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 3 months and 24 months old.

Select...

I was admitted for a bacterial infection like pneumonia or a skin abscess.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 hours post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 hours post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination

Amoxicillin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pediatric patients with a bacterial infectionExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

amoxicillin-clavulanic acid

2003

Completed Phase 1

~110

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaizen Bioscience Co.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this medical trial?

"This clinical trial seeks 24 infants between 3 and 24 months of age who have contracted a bacterial infection. The selection criteria necessitates that the subject is either male or female, with parents/guardians having consented to their participation in writing. Furthermore, participants must be recruited from emergency rooms and other urgent care centres - examples of infections include acute otitis media, community acquired pneumonia, aspiration (pneumonia), urinary tract infections etcetera."

Answered by AI

Are subjects aged 40 or above accepted for this clinical experiment?

"In accordance with this study's guidelines, the lower age limit for participation is 3 Months and the upper age boundary is 24 Months."

Answered by AI

Has the FDA sanctioned the use of antibacterial medications for pediatric cases?

"The safety of Pediatric patients with a bacterial infection was rated as 1 on our team's scale, due to the limited data ascertaining its efficacy and security in this Phase 1 trial."

Answered by AI

Are there any vacancies for participants in this clinical trial?

"As seen on clinicaltrials.gov, this particular study has concluded its patient recruitment phase and is no longer enrolling candidates. This trial was inaugurated in December 12th 2022 but had a final update posted on October 14th of the same year. Fortunately, there are 813 other trials actively recruiting patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection

2023. "A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05584683.