NCT01344512

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

3.3 years

First QC Date

April 27, 2011

Last Update Submit

March 17, 2015

Conditions

PediatricsCeftazidimeCiprofloxacinVoriconazole

Keywords

PharmacokineticPopulationChildrenCeftazidimeCiprofloxacinVoriconazolePediatric

Outcome Measures

Primary Outcomes (1)

  • 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.

    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...)

    Between 2 and 4 days after the beginning of the treatment

Study Arms (3)

Patients treated with Ceftazidime

EXPERIMENTAL
Drug: Ceftazidime

Patients treated with Ciprofloxacin

EXPERIMENTAL
Drug: Ciprofloxacin

Patients treated with Voriconazole

EXPERIMENTAL
Drug: Voriconazole

Interventions

CeftazidimeDRUG

Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.

Patients treated with Ceftazidime
CiprofloxacinDRUG

Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.

Patients treated with Ciprofloxacin
VoriconazoleDRUG

Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.

Patients treated with Voriconazole

Eligibility Criteria

Age28 Days - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Not Applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

CHU de Bordeaux, Hôpital Pellegrin

Bordeaux, 33076, France

Location

Hospices Civils de Lyon

Bron, 69500, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

CHRU Lille

Lille, 59037, France

Location

AP-HM, Hôpital La Timone

Marseille, 13005, France

Location

CHU Montpellier

Montpellier, 34925, France

Location

APHP - Hôpital NEcker

Paris, 75015, France

Location

AP-HP - Hôpital Robert Debré

Paris, 75019, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

CHU Rouen

Rouen, 76031, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

CHU tours

Tours, 37044, France

Location

Related Publications (1)

  • 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.

    PMID: 32457995DERIVED

MeSH Terms

Interventions

CeftazidimeCiprofloxacinVoriconazole

Intervention Hierarchy (Ancestors)

CephaloridineCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesTriazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Stéphanie Bui, Dr

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 29, 2011

Study Start

June 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

FR(14)