Lung Concentrations of Ceftazidime in Patients With Ventilator-associated Pneumonia

NCT02837835 | Completed Phase 3

• 1 other identifier: 104R04
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• lung tissue concentration of ceftazidime

  up to 44 hours

Study Arms (2)

continuous administration of ceftazidime

EXPERIMENTAL

Drug: ceftazidime

intermittent administration of ceftazidime

EXPERIMENTAL

Drug: ceftazidime

Interventions

ceftazidime DRUG

20 mg/kg of body weight followed by 60 mg/kg/day

continuous administration of ceftazidime

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

France, Reims, 51092, France

Location

Related Publications (1)

• Cousson J, Floch T, Guillard T, Vernet V, Raclot P, Wolak-Thierry A, Jolly D. Lung concentrations of ceftazidime administered by continuous versus intermittent infusion in patients with ventilator-associated pneumonia. Antimicrob Agents Chemother. 2015 Apr;59(4):1905-9. doi: 10.1128/AAC.04232-14. Epub 2015 Jan 12.

  PMID: 25583727 RESULT

MeSH Terms

Conditions

Pneumonia

Interventions

Ceftazidime

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 20, 2016
• Study Start: March 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

FR (1)