- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01499875
A Pharmacokinetic and Pharmacodynamic Study of Phenoxymethylpenicillin for Children
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Aarhus
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Skejby, Aarhus, Denmark, 8200
- Department of Pediatrics, Århus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Phenoxymethylpenicillin
It is a descriptive trial to find out about the pharmacokinetics
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mixture, 25 or 50 mg/kg taken once.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phenoxymethylpenicillin concentrations
Time Frame: up to 7 hours after the penicillin is taken
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The data will be presented before June 2013
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up to 7 hours after the penicillin is taken
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Niels H Birkebæk, PhD, Department of Pediatrics, Århus University Hospital, Skejby
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Penicillin
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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