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Clinical Trial Details

Trial ID: L1571
Source ID: NCT03634904
Associated Drug: Drug Bood Sampling
Title: Serum Ceftazidime Concentrations in Hemodialysis Patients
Acronym: CEFTAHEMOD
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Bacterial Infections|Ceftazidime|Renal Failure Chronic Requiring Hemodialysis
Interventions: DRUG: Drug bood sampling
Outcome Measures: Primary: Trough level at 8 mg/L or 1 x the MIC, total trough serum concentration of ceftazidime after its administration (loading dose and maintenance dose) and determining if it is higher or equal to 8 mg/L of 1 x the MIC, 7 days | Secondary: Trough level at 32 mg/L or 4 x the MIC, total trough serum concentration of ceftazidime after its administration (loading dose and maintenance dose) and determining if it is higher or equal to 32 mg/L of 4 x the MIC, 7 days|Free trough level at 8 mg/L or 1 x the MIC, Free trough serum concentration of ceftazidime after its administration (loading dose and maintenance dose) and determining if it is higher or equal to 8 mg/L of 1 x the MIC, 7 days|Free trough level at 32 mg/L or 4 x the MIC, Free trough serum concentration of ceftazidime after its administration (loading dose and maintenance dose) and determining if it is higher or equal to 32 mg/L of 4 x the MIC., 7 days|Impact of trough levels at 8 mg/L ot 1 x the MIC on clinical outcome, Number of patients for whom the total trough level is equal or higher than 8 mg/L or 1 x the MIC and who are either (i) cured, (ii) improved, or (iii) have failed to treatment (cure = cessation of the infection and no need of further treatment; improved: decrease of the signs of the infection but the same treatment is continued; failed: no cessation of the infection and need of a change of antibiotic or of its dosing)., 7 days|Impact of trough levels at 32 mg/L ot 4 x the MIC on clinical outcome, Number of patients for whom the total trough level is equal or higher than 32 mg/L or 4 x the MIC and who are either (i) cured, (ii) improved, or (iii) have failed to treatment (cure = cessation of the infection and no need of further treatment; improved: decrease of the signs of the infection but the same treatment is continued; failed: no cessation of the infection and need of a change of antibiotic or of its dosing)., 7 days|Impact of hemodialysis parameter #1 on ceftazidime total serum levels, Total ceftazidime concentrations (mg/L) in patients stratified according to the type of membrane \[code no.\]), 7 days|Impact of hemodialysis parameter #1 on ceftazidime free serum levels, Free ceftazidime concentrations (mg/L) in patients stratified according to the type of membrane \[code no.\]), 7 days|Impact of hemodialysis parameter #2 on ceftazidime total serum levels, Total ceftazidime concentrations (mg/L) in patients stratified according to the flow rate of the dialysis fluid \[mL/min\]., 7 days|Impact of hemodialysis parameter #2 on ceftazidime free serum levels, Free ceftazidime concentrations (mg/L) in patients stratified according to the flow rate of the dialysis fluid \[mL/min\]., 7 days|Impact of hemodialysis parameter #3 on ceftazidime total serum levels, Total ceftazidime concentrations (mg/L) in patients stratified according to the length of the dialysis session \[min\])., 7 days|Impact of hemodialysis parameter #3 on ceftazidime free serum levels, Free ceftazidime concentrations (mg/L) in patients stratified according to the length of the dialysis session \[min\])., 7 days|Impact of hemodialysis parameter #4 on ceftazidime total serum levels, Total ceftazidime concentrations (mg/L) in patients stratified according to the volume of ultrafiltration \[L\]), 7 days|Impact of hemodialysis parameter #4 on ceftazidime free serum levels, Free ceftazidime concentrations (mg/L) in patients stratified according to the volume of ultrafiltration \[L\]), 7 days|Impact of patient's residual renal function on ceftazidime total serum levels, Total ceftazidime concentrations (mg/L) in patients stratified according to their residual renal function using creatinine clearance (mL/h), 7 days|Impact of patient's residual renal function on ceftazidime free serum levels, Free ceftazidime concentrations (mg/L) in patients stratified according to their residual renal function using creatinine clearance (mL/h), 7 days|Impact of other drugs on ceftazidime serum total concentrations (mg/L)., Total ceftazidime concentrations (mg/L) in patients stratified according to the administration of other drugs (any), 7 days|Impact of other drugs on ceftazidime serum free concentrations (mg/L)., Free ceftazidime concentrations (mg/L) in patients stratified according to the administration of other drugs (any), 7 days|Impact of MIC on the clinical effectiveness of ceftazidime, MIC of the causative organism (if known; in mg/L) in patients stratified according to their clinical outcome (cured - improved - failed; cure = cessation of the infection and no need of further treatment; improved: decrease of the signs of the infection but the same treatment is continued; failed: no cessation of the infection and need of a change of antibiotic or of its dosing)/, 7 days
Sponsor/Collaborators: Sponsor: Centre Hospitalier Universitaire de Charleroi | Collaborators: Université Catholique de Louvain
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-09-15
Completion Date: 2021-09-15
Results First Posted:
Last Update Posted: 2018-08-17
Locations:
URL: https://clinicaltrials.gov/show/NCT03634904