Your session is about to expire
← Back to Search
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 belowSelect...
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
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
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
Find a Location
Who is running the clinical trial?
Kaizen Bioscience Co.Lead Sponsor
Share this study with friends
Copy Link
Messenger