In this study prophylactic moxifloxacin 400 mg i.v. is compared with the above mentioned standard antibiotic prophylaxis cefuroxime regimen with special consideration to the postoperative inflammatory response. Additionally the serum time-concentration curves are evaluated for pharmacokinetic data and antimicrobial activity.
Conditions
Interventions
Trade Name: Avalox
Product Name: Moxiloxacin
Product Code: 45263.00.01
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Moxilfoxacin
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
Institute of Anaesthesiology, German Heart Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: coronary artery disease scheduled for coronary artery bypass grafting with cardiopulmonary bypass Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Body mass index > 30 - Ejection fraction < 50 % - Severe cardiac arrhythmias (long QT syndrome) or intake of drugs which prolong the QT interval (available from: http://www.torsades.org) - Renal and hepatic dysfunction, evaluated by serum creatinine and SGOT/SGPT values above the normal range - Intake of corticosteroids - Allergies to quinolones, cephalosporins, aprotinin, or other drugs leading to the decision to omit these drugs or to give prophylactic antihistamines and corticosteroids - Antibiotic therapy or infectious disease until 2 weeks before start of the trial - Women who are pregnant (women with childbearing potential must have a negative pregnancy test) and nursing mothers - Tendinopathies caused by quinolones - Seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of prophylactic moxifloxacin and cefuroxime on the early inflammatory response to cardiopulmonary bypass in patients undergoing coronary artery bypass grafting;Secondary Objective: To assess the serum time-concentration curves for pharmacokinetic evaluation and antimicrobial activity in these patients;Primary end point(s): The difference between the moxifloxacin and cefuroxime group in the inflammatory response to cardiopulmonary bypass assessed by the level of pro- (IL6, IL8, TNFa) and anti-inflammatory (IL10) cytokines. | — |
Countries
Germany
Outcome results
None listed