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Lung Concentrations of Ceftazidime in Patients With Ventilator-associated Pneumonia (CEFTALC)

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ClinicalTrials.gov Identifier: NCT02837835
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: ceftazidime Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: continuous administration of ceftazidime Drug: ceftazidime
20 mg/kg of body weight followed by 60 mg/kg/day

Experimental: intermittent administration of ceftazidime Drug: ceftazidime
20 mg/kg over 30 min every 8 h




Primary Outcome Measures :
  1. lung tissue concentration of ceftazidime [ Time Frame: up to 44 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age >18 years;
  • Patients hospitalized in the general intensive care unit of the University Hospital of Reims;
  • Nosocomial pneumonia with Gram-negative.

Exclusion Criteria:

  • Weight >110 kg;
  • Pregnant or breastfeeding women;
  • Known allergy to beta - lactam antibiotics;
  • Renal impairment: clearance <60 calculated by the Cockcroft and Gault;
  • Known history of pulmonary fibrosis;
  • Patients included in another research protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837835


Locations
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France
Chu Reims
France, Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
Publications of Results:
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02837835    
Other Study ID Numbers: 104R04
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ceftazidime
Anti-Bacterial Agents
Anti-Infective Agents