infected foot ulcers in diabetic patient MedDRA version: 9.1 Level: LLT Classification code 10060803 Term: Diabetic foot infection
Conditions
Interventions
Trade Name: TAVANIC
Product Name: TAVANIC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: levofloxacine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Con
Sponsors
CHU DE POITIERS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the distribution in subcutaneous tissues of the free ertapeneme and free levofloxacine administered to diabetics patients having an infection of the foot, requiring a treatment by the combination of ertapeneme and levofloxacine.;Secondary Objective: To compare the free concentrations of ertapeneme and levofloxacine obtained in the tissue under cutaneous healthy and the subcutaneous infected tissue to the same patient.To estimate the pharmacokinetic of ertapeneme and levofloxacine in plasma of diabetics patients. To explore the tolerance of microdialysis probes.;Primary end point(s): Comparison of area under the curves of the free concentrations of ertapeneme and levofloxacine in the interstitial fluid between subcutaneous tissue of healthy thigh tissue, and the diabetic foot and plasma. | — |
Countries
France
Outcome results
None listed