A Pharmacokinetic and Pharmacodynamic Study of Phenoxymethylpenicillin for Children

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Aarhus University Hospital
Department of Microbiological Surveillance and Research, SSI.
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01499875
First received: August 18, 2011
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

The aim of this trial is to evaluate the pharmacokinetics and pharmacodynamics of penicillin V in non-infectious children to estimate the optimum dosage regime in children.


Condition Intervention Phase
Phenoxymethylpenicillin
Drug: Phenoxymethylpenicillin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic and Pharmacodynamic Study of Phenoxymethylpenicillin for Children

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Phenoxymethylpenicillin concentrations [ Time Frame: up to 7 hours after the penicillin is taken ] [ Designated as safety issue: No ]
    The data will be presented before June 2013


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phenoxymethylpenicillin
It is a descriptive trial to find out about the pharmacokinetics
Drug: Phenoxymethylpenicillin
mixture, 25 or 50 mg/kg taken once.
Other Name: Primcillin

Detailed Description:

Although occasionally questioned, the efficacy of penicillin in eradication of respiratory tract infections in children has not been convincingly reported in the literature. Two randomized multicenter antibiotic efficacy trials have been reported in eradication of group A streptococci where both oral and intramuscular administration of penicillin had relatively high microbiologic failure rates. But the trials only confirm that the treatment is not effective in the given dose. The recent recommendations on penicillin are unfortunately based upon past practices, clinical trial results and recent resistance trends and pharmacodynamics have not been considered to support the choice of drug and dosage regimen. Some pharmacodynamic trials have been made on meropenem, cefotaxime, piperacillin-tazobactam and amoxicillin in children but so fare no trials have been described on penicillin. It is well described in adults but the absorption and secretion might be depended on age. Penicillin exhibit a time-dependent killing which means that the time over minimal inhibitory concentration (MIC) is the parameter best related to efficacy.

Methods:

The investigators evaluate the pharmacokinetics and pharmacodynamics of penicillin V in non-infectious Danish children at age 0-10 years who were admitted for a chromium-51-EDTA-clearance test. The investigators excluded children with allergy to penicillin and children with a prior known reduced glomerular filtration rate. The parents of each child who participated gave written informed consent before the study and ethical approval was obtained.

Antimicrobial dosage and administration:

40 children were assigned to receive per oral penicillin suspension 22-32 mg/kg. The dosage was estimated 25 mg/kg by the weight the parents rapported and they had a weight control at admission. The exact given dose was then calculated. The penicillin were not taken on an empty stomach to imitate reality as much as possible and the time of administration was noted. Another 40 children were given 50 mg/kg penicillin mixture.

Samples:

Blod samples of 1 ml were taken after 0, 15, 30, 60, 90, 120 minutes after the Crom-EDTA examination had started giving a dispersion in time compared to the intake of penicillin. The samples were collected in vacuum tubes containing EDTA as an anticoagulant and then centrifuged quickly. The separated serum were placed in cryovials before frozen.

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-infectious Danish children at age 0-10 years who were admitted for a chromium51EDTA clearance test

Exclusion Criteria:

  • Children with allergy to penicillin and children with a prior known reduced glomerular filtration rate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499875

Locations
Denmark
Department of Pediatrics, Århus University Hospital
Skejby, Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Department of Microbiological Surveillance and Research, SSI.
Investigators
Study Chair: Niels H Birkebæk, PhD Department of Pediatrics, Århus University Hospital, Skejby
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01499875     History of Changes
Other Study ID Numbers: Penicillin
Study First Received: August 18, 2011
Last Updated: January 23, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Pharmacokinetic
Pharmacodynamic
Phenoxymethylpenicillin
Children

Additional relevant MeSH terms:
Penicillin V
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014