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A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Single Dose Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Pediatric Patients Receiving Either LP-001 or Augmentin ES-600 Orally

NCT05584683•Kaizen Bioscience Co.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation compared to the pharmacokinetic profiles of Augmentin ES-600 for use in pediatric patients with a bacterial infection.

Detailed Description

This is a single site, open-label, single dose Phase 1 pharmacokinetic study of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients between 3 and 24 months of age with a bacterial infection. 24 pediatric patients will each receive a single dose of LP-001 in a fed state while 15 pediatric patients will each receive a single dose of Augmentin ES-600 in a fed state. 3-4 blood draws per patient will be attempted up to 8 hours post dose.

Eligibility

Age

0 - 2 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•2\. Since amoxicillin/clavulanic acid is currently only approved for acute otitis media (AOM) by the Food and Drug Administration in the 3-24 month old age range, we will also include a portion of patients recruited from urgent care/emergency room or outpatient setting with a documented AOM diagnosis per provider's exam with planned prescription for amoxicillin or amoxicillin/clavulanic acid to address any of the concerns below: i) onset of symptoms within 48 hours ii) middle ear effusion as demonstrated by ≥2 of the following:
•1. decreased or absent mobility of the tympanic membrane
•2. yellow or white discoloration of the tympanic membrane
•3. opacification of the tympanic membrane. iii) acute inflammation demonstrated by:
•(1) moderate or marked bulging of the tympanic membrane, or slight bulging accompanied with apparent otalgia or marked tympanic membrane erythema.
•Or A documented OM diagnosis per provider's exam with planned prescription for amoxicillin or amoxicillin/clavulanic acid.
•3\. Patients recruited from the inpatient setting who have not yet received an amoxicillin containing product (i.e. on an IV antibiotic, or diagnosis and treatment not started until after admission, or diagnosis does not warrant an antibiotic). Examples could include, but are not limited to one of the following diagnosis: acute otitis media, otitis media, community acquired pneumonia, aspiration (pneumonia), urinary tract infections, lymphadenitis, retropharyngeal abscess, peritonsillar abscess, animal or human bite, cellulitis, skin abscess, bronchiolitis or dental infection. If the clinical team decides to transition the patient to an amoxicillin-containing product for continuation of treatment, a single test dose of LP-001 would serve as the first dose of enteral treatment.
•4\. Written informed consent by the patient's parent or legal guardian and where appropriate.
•5\. Based upon IRB guidelines, blood volume for PK sampling, based on body weight, will be less than 5% of blood volume per day based upon 70-80 mL blood/kg. Blood sampling will be done between 1-4 time points per patient totaling a blood volume of between 1-3ml.

Exclusion Criteria

•Patients will be excluded from the study if they satisfy any of the following criteria:
•1. Definite or suspected personal history or family history of significant hypersensitivity, intolerance, or allergy to penicillin, amoxicillin, amoxicillin clavulanate, or aspartame. History of reaction to multiple allergens (if considered clinically relevant by the principal investigator or designee).
•2. Children who weigh less than 5 kg or more than 40kg. Patients who are younger than 3 months or older than 24 months (i.e. past their 2nd birthday).
•3. Patients with a serious underlying disease, including failure to thrive, which could affect the safety, efficacy, or pharmacokinetics of the study medication.
•4. History or presence of gastrointestinal, hepatic, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism or excretion of study medication.
•5. History of diarrhea due to Clostridium difficile following treatment with antibiotics.
•Have a serious underlying systemic clinical manifestation that may obscure response to infection (eg, cystic fibrosis, neoplasms, or juvenile diabetes), as determined by the investigator (or designee).
•7\. Have renal or hepatic dysfunction or insufficiency. 8. Have immune dysfunction or are receiving immunosuppressive therapy. 9. Have a chronic gastrointestinal condition (eg, malabsorption or inflammatory bowel disease), as determined by the investigator (or designee).
•10\. Have phenylketonuria or history of amoxicillin clavulanate associated cholestatic jaundice.
•11\. Have a systolic blood pressure \<60 mmHg or capillary refill \>3 seconds. 12. Use of any amoxicillin product within the previous 96 hours. 13. Poor peripheral venous access. 14. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days, current enrollment in another clinical study that could impact the results of this study, or previous enrollment in this clinical study.
+2 more criteria

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

August 9, 2023

Primary Completion Date

December 16, 2024

Completion Date

December 16, 2024

Last Updated

February 5, 2025

Enrollment

ACTUAL participants

Conditions

PediatricBacterial Infections

Interventions

Amoxicillin potassium clavulanate

DRUG

Amoxicillin potassium clavulanate (Augmentin ES-600)

DRUG

Transcutaneous pO₂ Monitoring in PICU

NCT07478380

Pediatric Critical Illness

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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: February 5, 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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A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection

Inclusion Criteria

Exclusion Criteria

Transcutaneous pO₂ Monitoring in PICU

Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

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