PediatricsPHARMA-ANCT01344512
Population Pharmacokinetics of Anti-infectious Drugs in Children
A study testing Ceftazidime, Ciprofloxacin and Voriconazole in people with Pediatrics and Ceftazidime, run by University Hospital, Bordeaux at 14 sites in France.
Trial summary
The Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years. Read more about this study
- Who is it for?
- Ages 28 days to 6 years
- Conditions the study is for
- Pediatrics, Ceftazidime, Ciprofloxacin
- What is being tested?
- Ceftazidime, Ciprofloxacin and Voriconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 14 sitesFrance
- Study dates
- Jun 2011to Sep 2014
- Phase
- Interventional
- 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 28 days to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 28 days to 11 years (< 12 years)
- Receiving one of the following drugs for therapeutic reasons : ceftazidime, ciprofloxacin, voriconazole
- Representative for the clinician, a condition requiring the use of these molecules
- Informed consent signed by the two parents or legal representative
- Child affiliated to the national social security system
Who cannot join
- Not Applicable
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
CHU de Bordeaux, Hôpital Pellegrin
Bordeaux, 33076
Hospices Civils de Lyon
Bron, 69500
CHU Clermont Ferrand
Clermont-Ferrand, 63000
CHU de Dijon
Dijon, 21079
CHU de Grenoble
Grenoble, 38043
CHRU Lille
Lille, 59037
AP-HM, Hôpital La Timone
Marseille, 13005
CHU Montpellier
Montpellier, 34925
APHP - Hôpital NEcker
Paris, 75015
AP-HP - Hôpital Robert Debré
Paris, 75019
CHU Poitiers
Poitiers, 86000
CHU Rouen
Rouen, 76031
CHU Toulouse
Toulouse, 31059
CHU tours
Tours, 37044
About this study
Official title: Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)
The Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.
Read the detailed description
The licensing process was introduced in order to ensure that medicines are safe, effective and of high quality. However, over 50% of children admitted to hospital in France and Europe will receive an unlicensed or off-label medicine. This occurs for most drugs in children less than 6 years of age. They represent a particularly vulnerable subgroup of the paediatric population.
There are major practical and ethical issues in relation to studying medicines in paediatric patients aged 5 years or less.
- They represent only a small part of the population as compared to older children and adults, and the variation of specific types of diseases in this young subpopulation is higher than in the paediatric counterpart. There are major differences in drug disposition in the different age groups.
- There is a need for suitable methodological approaches for clinical trials
- There are major ethical issues It is essential, therefore, to recruit children from various regions in France in order to obtain a critical sample size of sufficient magnitude and to conduct scientific sound studies. This will be achieved by performing Pharm A, a population pharmacokinetic study of three different anti infectious agents (ceftazidime, ciprofloxacin, voriconazole) and identify covariates including pharmacogenetic biomarkers that explain pharmacokinetic variability.
After parental informed consent, sampling strategy will be randomized depending on the drug and the age group (2 samples in patients below 2 years and 3 samples in patients from 2 to 5 years).
- Conditions
- Pediatrics, Ceftazidime, Ciprofloxacin, Voriconazole
- Being tested
- Ceftazidime, Ciprofloxacin, Voriconazole
- Keywords
- Pharmacokinetic, Population, Children, Ceftazidime, Ciprofloxacin, Voriconazole, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftazidimeDrug
Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.
CiprofloxacinDrug
Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.
VoriconazoleDrug
Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Ceftazidime | Experimental | Not described Receives: Drug: Ceftazidime |
| Patients treated with Ciprofloxacin | Experimental | Not described Receives: Drug: Ciprofloxacin |
| Patients treated with Voriconazole | Experimental | Not described Receives: Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population pharmacokinetic parameters and factors explaining variability
Population Pharmacokinetic Parameters and variability factors (Sex, Age, Genetic factors...) for ceftazidime, ciprofloxacin and voriconazole.
According to the age of participants, 2 or 3 bloods sampling will be take between 2 and 4 days after the beginning of the treatment.
Measured: Between 2 and 4 days after the begining of the treatment
Secondary outcomes (1)
Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...)
Measured: Between 2 and 4 days after the beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PediatricsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Bui, Dr, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344512
- Sponsor's protocol ID
- CHUBX 2010/36
- Acronym
- PHARMA-A
- Status last verified
- Mar 2015
- First submitted
- 27 Apr 2011
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bui S, Facchin A, Ha P, Bouchet S, Leroux S, Nacka F, Fayon M, Jacqz-Aigrain E. Population pharmacokinetics of ceftazidime in critically ill children: impact of cystic fibrosis. J Antimicrob Chemother. 2020 Aug 1;75(8):2232-2239. doi: 10.1093/jac/dkaa170.
PubMed 32457995
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)
- ClinicalTrials.gov ID
- NCT01344512
- Acronym / sponsor ID
- PHARMA-A / CHUBX 2010/36
- Conditions
- Pediatrics, Ceftazidime, Ciprofloxacin, Voriconazole
- Keywords
- Pharmacokinetic, Population, Children, Ceftazidime, Ciprofloxacin, Voriconazole, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Apr 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 Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.
Detailed description
The licensing process was introduced in order to ensure that medicines are safe, effective and of high quality. However, over 50% of children admitted to hospital in France and Europe will receive an unlicensed or off-label medicine. This occurs for most drugs in children less than 6 years of age. They represent a particularly vulnerable subgroup of the paediatric population.
There are major practical and ethical issues in relation to studying medicines in paediatric patients aged 5 years or less.
- They represent only a small part of the population as compared to older children and adults, and the variation of specific types of diseases in this young subpopulation is higher than in the paediatric counterpart. There are major differences in drug disposition in the different age groups.
- There is a need for suitable methodological approaches for clinical trials
- There are major ethical issues It is essential, therefore, to recruit children from various regions in France in order to obtain a critical sample size of sufficient magnitude and to conduct scientific sound studies. This will be achieved by performing Pharm A, a population pharmacokinetic study of three different anti infectious agents (ceftazidime, ciprofloxacin, voriconazole) and identify covariates including pharmacogenetic biomarkers that explain pharmacokinetic variability.
After parental informed consent, sampling strategy will be randomized depending on the drug and the age group (2 samples in patients below 2 years and 3 samples in patients from 2 to 5 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Ceftazidime | Experimental | Drug: Ceftazidime |
| Patients treated with Ciprofloxacin | Experimental | Drug: Ciprofloxacin |
| Patients treated with Voriconazole | Experimental | Drug: Voriconazole |
Who may qualify
- Ages
- 28 days to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 28 days to 11 years (< 12 years)
- Receiving one of the following drugs for therapeutic reasons : ceftazidime, ciprofloxacin, voriconazole
- Representative for the clinician, a condition requiring the use of these molecules
- Informed consent signed by the two parents or legal representative
- Child affiliated to the national social security system
Key exclusion criteria (1 listed)
- Not Applicable
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 |
|---|---|---|
| CeftazidimeBloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment. | Drug | Patients treated with Ceftazidime |
| CiprofloxacinBloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment. | Drug | Patients treated with Ciprofloxacin |
| VoriconazoleBloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment. | Drug | Patients treated with Voriconazole |
Primary outcome
Population pharmacokinetic parameters and factors explaining variability
Time frame: Between 2 and 4 days after the begining of the treatment
Population Pharmacokinetic Parameters and variability factors (Sex, Age, Genetic factors...) for ceftazidime, ciprofloxacin and voriconazole. According to the age of participants, 2 or 3 bloods sampling will be take between 2 and 4 days after the beginning of the treatment.
1 secondary outcome
Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...)
Time frame: Between 2 and 4 days after the beginning of the treatment
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 18 Mar 2015.
- Derived from this study: PubMed 32457995Bui S, Facchin A, Ha P, Bouchet S, Leroux S, Nacka F, Fayon M, Jacqz-Aigrain E. Population pharmacokinetics of ceftazidime in critically ill children: impact of cystic fibrosis. J Antimicrob Chemother. 2020 Aug 1;75(8):2232-2239. doi: 10.1093/jac/dkaa170.
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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.
Stéphanie Bui, Dr principal investigator
University Hospital Bordeaux, France
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceftazidime, Ciprofloxacin and Voriconazole in people with Pediatrics and Ceftazidime, run by University Hospital, Bordeaux at 14 sites in France.
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 5 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. 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.
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?
Population pharmacokinetic parameters and factors explaining variability (time frame: Between 2 and 4 days after the begining of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01344512, which also lists 1 linked publication.
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 18 Mar 2015.