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

• Conditions: infected foot ulcers in diabetic patient; MedDRA version: 9.1Level: LLTClassification code 10060803Term: Diabetic foot infection

• Registration Number: EUCTR2007-001701-19-FR
• Lead Sponsor: CHU DE POITIERS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified