Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT02837835
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2016-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Concentrations of Ceftazidime in Patients With Ventilator-associated Pneumonia
Sponsor:
CHU de Reims
Organization:
Study Overview
Official Title:
Comparison of Lung Concentrations of Ceftazidime Administered by Continuous Versus Intermittent Infusion in Patients With Ventilator-associated Pneumonia
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEFTALC
Brief Summary:
Ceftazidime is a beta-lactam compound that exerts a time-dependent bactericidal effect. Numerous arguments are in favor of continuous administration of ceftazidime, both for reasons of clinical efficacy and to preserve bacteriological mutation. The investigators report a prospective, single-center, parallel-group, randomized, controlled trial comparing two modes of administration of ceftazidime, namely, continuous administration (loading dose of 20 mg/kg of body weight followed by 60 mg/kg/day) versus intermittent administration (20 mg/kg over 30 min every 8 h) in 34 patients with ventilator-associated pneumonia due to Gram-negative bacilli. The study was performed over 48 h with 13 and 18 assessments of serum ceftazidime in the continuous-infusion group (group A) and the intermittent-fusion group (group B), respectively. Bronchoalveolar lavage (BAL) was performed at steady state in both groups at 44 h to determine ceftazidime levels in the epithelial lining fluid. The investigators chose a predefined threshold of 20 mg/liter for serum concentrations of ceftazidime because of ecological conditions in our center.
Detailed Description:
Primary objective
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.
Methods
Trial
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.
Population
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:
1. Criteria for inclusion and non-inclusion (see above);
2. Outcome:
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;
3. Socio-demographic variables: Age, Gender;
4. 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;
5. Urinary Assays: Creatinine clearance and urinary electrolytes.
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.
Methods
Trial
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.
Population
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:
1. Criteria for inclusion and non-inclusion (see above);
2. Outcome:
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;
3. Socio-demographic variables: Age, Gender;
4. 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;
5. Urinary Assays: Creatinine clearance and urinary electrolytes.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: