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A Pharmacokinetic and Pharmacodynamic Study of Phenoxymethylpenicillin for Children

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ClinicalTrials.gov Identifier: NCT01499875
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : October 1, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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
Phenoxymethylpenicillin Drug: Phenoxymethylpenicillin 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  (Clinical Trial)
Actual Enrollment : 80 participants
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 : January 2012
Primary Completion Date : June 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Phenoxymethylpenicillin concentrations [ Time Frame: up to 7 hours after the penicillin is taken ]
    The data will be presented before June 2013


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499875


Locations
Denmark
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
More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01499875     History of Changes
Other Study ID Numbers: Penicillin
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: January 2013

Keywords provided by University of Aarhus:
Pharmacokinetic
Pharmacodynamic
Phenoxymethylpenicillin
Children

Additional relevant MeSH terms:
Penicillin V
Anti-Bacterial Agents
Anti-Infective Agents