PhenoxymethylpenicillinPhase 1NCT01499875
A Pharmacokinetic and Pharmacodynamic Study of Phenoxymethylpenicillin for Children
A Phase 1 study testing Phenoxymethylpenicillin in people with Phenoxymethylpenicillin, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages Up to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Phenoxymethylpenicillin
- What is being tested?
- Phenoxymethylpenicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Non-infectious Danish children at age 0-10 years who were admitted for a chromium51EDTA clearance test
Who cannot join
- Children with allergy to penicillin and children with a prior known reduced glomerular filtration rate
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Pediatrics, Århus University Hospital
Skejby, Aarhus, 8200
About this study
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.
Read the 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.
- Conditions
- Phenoxymethylpenicillin
- Being tested
- Phenoxymethylpenicillin
- Keywords
- Pharmacokinetic, Pharmacodynamic, Phenoxymethylpenicillin, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenoxymethylpenicillinDrug
Also called Primcillin
mixture, 25 or 50 mg/kg taken once.
| Study group | Role | What they receive |
|---|---|---|
| Phenoxymethylpenicillin | Other | It is a descriptive trial to find out about the pharmacokinetics Receives: Drug: Phenoxymethylpenicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenoxymethylpenicillin concentrations
The data will be presented before June 2013
Measured: up to 7 hours after the penicillin is taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhenoxymethylpenicillinStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Department of Microbiological Surveillance and Research, SSI.
- Responsible party
- Sponsor
- Investigators
- Niels H Birkebæk, PhD, Study chair, Department of Pediatrics, Århus University Hospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499875
- Sponsor's protocol ID
- Penicillin
- Status last verified
- Jan 2013
- First submitted
- 18 Aug 2011
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic and Pharmacodynamic Study of Phenoxymethylpenicillin for Children
- ClinicalTrials.gov ID
- NCT01499875
- Acronym / sponsor ID
- Penicillin
- Conditions
- Phenoxymethylpenicillin
- Keywords
- Pharmacokinetic, Pharmacodynamic, Phenoxymethylpenicillin, Children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Department of Microbiological Surveillance and Research, SSI.
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phenoxymethylpenicillin | Other | Drug: PhenoxymethylpenicillinIt is a descriptive trial to find out about the pharmacokinetics |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Non-infectious Danish children at age 0-10 years who were admitted for a chromium51EDTA clearance test
Key exclusion criteria (1 listed)
- Children with allergy to penicillin and children with a prior known reduced glomerular filtration rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenoxymethylpenicillinAlso: Primcillinmixture, 25 or 50 mg/kg taken once. | Drug | Phenoxymethylpenicillin |
Primary outcome
Phenoxymethylpenicillin concentrations
Time frame: up to 7 hours after the penicillin is taken
The data will be presented before June 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
Related trials for Phenoxymethylpenicillin
Not yet recruitingPhase 3
Penicillin to Prevent Early Rheumatic Heart Disease in School-Aged Children
Rheumatic Heart Disease in Children
RecruitingPhase 4
Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment
Sore Throat, Tonsillitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels H Birkebæk, PhD study chair
Department of Pediatrics, Århus University Hospital, Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phenoxymethylpenicillin in people with Phenoxymethylpenicillin, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenoxymethylpenicillin concentrations (time frame: up to 7 hours after the penicillin is taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.