Clincosm LogoSign in Get a demo

A Pharmacokinetic and Pharmacodynamic Study of Phenoxymethylpenicillin for Children

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT01499875
Collaborator
Aarhus University Hospital Skejby (Other), Department of Microbiological Surveillance and Research, SSI. (Other)
80
Enrollment
1
Location
1
Arm
19
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pharmacokinetic and Pharmacodynamic Study of Phenoxymethylpenicillin for Children
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: Phenoxymethylpenicillin

It is a descriptive trial to find out about the pharmacokinetics

Drug: Phenoxymethylpenicillin
mixture, 25 or 50 mg/kg taken once.
Other Names:
  • Primcillin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Phenoxymethylpenicillin concentrations [up to 7 hours after the penicillin is taken]

      The data will be presented before June 2013

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Department of Pediatrics, Århus University Hospital Skejby Aarhus Denmark 8200

    Sponsors and Collaborators

    • University of Aarhus
    • Aarhus University Hospital Skejby
    • Department of Microbiological Surveillance and Research, SSI.

    Investigators

    • Study Chair: Niels H Birkebæk, PhD, Department of Pediatrics, Århus University Hospital, Skejby

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT01499875
    Other Study ID Numbers:
    • Penicillin
    First Posted:
    Dec 26, 2011
    Last Update Posted:
    Oct 1, 2014
    Last Verified:
    Jan 1, 2013
    Keywords provided by University of Aarhus
    Pharmacokinetic
    Pharmacodynamic
    Phenoxymethylpenicillin
    Children
    Additional relevant MeSH terms:
    Penicillin V

    Study Results

    No Results Posted as of Oct 1, 2014