Lung Concentrations of Ceftazidime in Patients With Ventilator-associated Pneumonia (CEFTALC)
|ClinicalTrials.gov Identifier: NCT02837835|
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : July 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Drug: ceftazidime||Phase 3|
The main objective of this study is to show the continuous administration of superiority ceftazidime versus intermittent administration, in terms of lung tissue concentration of ceftazidime in mechanically ventilated patients with pneumonia caused by a bacillus gram negative.
Prospective therapeutic trial in parallel groups, controlled, randomized, single center comparing two methods of administration of ceftazidime (continuous administration by self-pulsed syringe versus discontinuous administration regimens to 3 injections per 24 hours) in patients with severe pneumonia in mechanically ventilated due to gram negative bacillus.
Patients will be enrolled in the Intensive Care Unit of the Reims university hospital.
All patients meeting the inclusion criteria and respecting the criteria of non-inclusions (see below) will be consecutively enrolled in the study after obtaining consent. The allocation of one of the 2 treatment modality will be made by randomization.
Variables and parameters collected in the study:
In addition to sociodemographic variables, variables for inclusion in the study and judgment criteria, different blood and urine tests will be collected:
- Criteria for inclusion and non-inclusion (see above);
i) concentration in the cell film ceftazidime;
ii) serum concentration of ceftazidime;
iii) period during which the serum concentration of ceftazidime is higher than 20 mg/l;
- Socio-demographic variables: Age, Gender;
- Blood Assays: Blood gas; Blood Urea, créatinimémie and chemistry panel; serum protein; Complete Blood Count; Beta HCG if women of childbearing age; Liver function tests: AST, ALT, GGT, bilirubin, alkaline phosphatase;
- Urinary Assays: Creatinine clearance and urinary electrolytes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Lung Concentrations of Ceftazidime Administered by Continuous Versus Intermittent Infusion in Patients With Ventilator-associated Pneumonia|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
|Experimental: continuous administration of ceftazidime||
20 mg/kg of body weight followed by 60 mg/kg/day
|Experimental: intermittent administration of ceftazidime||
20 mg/kg over 30 min every 8 h
- lung tissue concentration of ceftazidime [ Time Frame: up to 44 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837835
|France, Reims, France, 51092|