Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01499875 |
| Other study ID # |
Penicillin |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
August 18, 2011 |
| Last updated |
September 30, 2014 |
| Start date |
January 2012 |
| Est. completion date |
August 2013 |
Study information
| Verified date |
January 2013 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: The Danish National Committee on Biomedical Research Ethics |
| Study type |
Interventional
|
Clinical Trial 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.
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.
