pharmacokinetic study by microdialysis of the distribution of ertapeneme and levofloxacine in infected foot ulcers of diabetics patients.

CHU DE POITIERS0 个研究点开始时间: 2007年9月28日最近更新: 2012年3月19日

试验速览

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•-More than 18 years old .
•-Hospitalized for an infection of soft tissues of the foot owed to one germ sensitive to combination of ertapeneme and levofloxacine.
•-Having had an echo-Doppler of femoral arteries.
•-Having given their written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-Known AIDS or positive serology for the antigen HBs, the antibodies anti HBc, anti HCV, anti HIV,
•-Nobody having looked blood in the month before the inclusion, or wishing to donate in the next month
•-Previous Treatment by ertapeneme (during the week preceding the inclusion) previous history of unwanted effects bound to the administration of ertapeneme or a product of the family of carbapeneme-Previous Treatment by levofloxacine (during the week preceding the inclusion)
•– previous history of unwanted effects bound to the administration of levofloxacine or a product of the family of quinolones-haemoglobin rate< 9 g / dL for the not coronary subjects, or < 10 g / dL for the coronary subjects
•-Presence of a renal insufficiency (clearance of the creatinine < 30 ml / min / 1.73 m2, according to the Cockcroft and Gault formula)
•-Leucopenia < 500 / mm3
•-Patient receiving cathecolamine drugs (epinephrin, norepinephrin) whatever is the dose
•-Acute cardiac insufficiency (NYHA III or IV)
•-Pregnant or breast-feeding Woman,
•-Patients in the period of exclusion from the French National File ( 3 months),
•- severe hyper-susceptibility to one beta lactam agent
•- prior history of epilepsy
•- deficiency of glucose-6-phosphate deshydrogenase
•- prior history of fluoroquinolone associated tendinopathy

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