Pharmacokinetics study of Cefazolin in haemodialysis (CEFAZODIAL)

Conditions

Chronic haemodialysis patients suffering from infection.

Brief summary

Time during which the plasma concentration of cefazolin is greater than the target concentration of 40 mg/L.

Detailed description

Occurrence of adverse events (within 6 weeks of last dose), Early clinical efficacy (at 1 week from start of treatment) in cefazolin-susceptible patients, defined as freedom from failure, composite endpoint including: 1/ Persistence of fever >38°C 2/ Persistence of positive blood cultures for the same germ(s) 3/ Death for infectious reasons 4/ Change of antibiotic therapy due to ineffectiveness, Late clinical efficacy (at 6 weeks from the start of treatment) in patients with cefazolin-susceptible organisms, defined as absence of failure, composite criterion including : 1/ Persistence of positive blood cultures 2/ Recurrence of initial infection 3/ Death due to infection 4/ Change of antibiotic therapy due to ineffectiveness, Each of the criteria of the 2 composite scores taken in isolation, Association of pharmacokinetic variability factors (covariates) with the occurrence of under- or over-exposure (concentration below 40mg/L or above 80mg/L)

Related papers

No related papers found yet.

Interventions

DRUGCEFAZOLIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time during which the plasma concentration of cefazolin is greater than the target concentration of 40 mg/L.	—

Secondary

Measure	Time frame
Occurrence of adverse events (within 6 weeks of last dose), Early clinical efficacy (at 1 week from start of treatment) in cefazolin-susceptible patients, defined as freedom from failure, composite endpoint including: 1/ Persistence of fever >38°C 2/ Persistence of positive blood cultures for the same germ(s) 3/ Death for infectious reasons 4/ Change of antibiotic therapy due to ineffectiveness, Late clinical efficacy (at 6 weeks from the start of treatment) in patients with cefazolin-susceptible organisms, defined as absence of failure, composite criterion including : 1/ Persistence of positive blood cultures 2/ Recurrence of initial infection 3/ Death due to infection 4/ Change of antibiotic therapy due to ineffectiveness, Each of the criteria of the 2 composite scores taken in isolation, Association of pharmacokinetic variability factors (covariates) with the occurrence of under- or over-exposure (concentration below 40mg/L or above 80mg/L)	—

Measure

Time frame

Occurrence of adverse events (within 6 weeks of last dose), Early clinical efficacy (at 1 week from start of treatment) in cefazolin-susceptible patients, defined as freedom from failure, composite endpoint including: 1/ Persistence of fever >38°C 2/ Persistence of positive blood cultures for the same germ(s) 3/ Death for infectious reasons 4/ Change of antibiotic therapy due to ineffectiveness, Late clinical efficacy (at 6 weeks from the start of treatment) in patients with cefazolin-susceptible organisms, defined as absence of failure, composite criterion including : 1/ Persistence of positive blood cultures 2/ Recurrence of initial infection 3/ Death due to infection 4/ Change of antibiotic therapy due to ineffectiveness, Each of the criteria of the 2 composite scores taken in isolation, Association of pharmacokinetic variability factors (covariates) with the occurrence of under- or over-exposure (concentration below 40mg/L or above 80mg/L)

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Countries

France

Outcome results

None listed