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Michio Ohta - One of the best experts on this subject based on the ideXlab platform.
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Effects of aztreonam in combination with antipseudomonal antibiotics againstPseudomonas aeruginosa isolated from patients with chronic or recurrent lower respiratory tract infection
Journal of Infection and Chemotherapy, 1998Co-Authors: Kenichi Yamaki, Kenzo Takagi, Toshihiko Tanaka, Michio OhtaAbstract:The antipseudomonal activity of aztreonam combined with other antibiotics aas examined in vitro to suggest effective therapeutic combinations for the treatment of respiratory tract infections due to Pseudomonas aeruginosa . Twenty-five P. aeruginosa strains were newly isolated from patients with chronic or recurrent lower respiratory tract infection. The susceptibility of these strains to aztreonam alone and to aztreonam combined with ceftazidime, cefclidin, Isepamicin and imipenem was measured using the checkerboard method. The observed MICs suggested that aztreonam alone was not very potent against P. aeruginosa associated with chronic or recurrent lower respiratory infection, but that cefclidin had strong antipseudomonal activity. The fractionary inhibitory concentration index showed synergy in 60% of the P. aeruginosa clinical isolates with aztreonam plus Isepamicin, and antagonism in approximately 16% of strains with aztreonam plus imipenem. When combined with isepamcin, aztreonam may have potent activity against pseudomonal lower respiratory tract infections.
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effects of aztreonam in combination with antipseudomonal antibiotics against pseudomonas aeruginosa isolated from patients with chronic or recurrent lower respiratory tract infection
Journal of Infection and Chemotherapy, 1998Co-Authors: Kenichi Yamaki, Kenzo Takagi, Toshihiko Tanaka, Michio OhtaAbstract:The antipseudomonal activity of aztreonam combined with other antibiotics aas examined in vitro to suggest effective therapeutic combinations for the treatment of respiratory tract infections due toPseudomonas aeruginosa. Twenty-fiveP. aeruginosa strains were newly isolated from patients with chronic or recurrent lower respiratory tract infection. The susceptibility of these strains to aztreonam alone and to aztreonam combined with ceftazidime, cefclidin, Isepamicin and imipenem was measured using the checkerboard method. The observed MICs suggested that aztreonam alone was not very potent againstP. aeruginosa associated with chronic or recurrent lower respiratory infection, but that cefclidin had strong antipseudomonal activity. The fractionary inhibitory concentration index showed synergy in 60% of theP. aeruginosa clinical isolates with aztreonam plus Isepamicin, and antagonism in approximately 16% of strains with aztreonam plus imipenem. When combined with isepamcin, aztreonam may have potent activity against pseudomonal lower respiratory tract infections.
Olivier Petitjean - One of the best experts on this subject based on the ideXlab platform.
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Clinical Pharmacokinetics and Pharmacodynamics of Isepamicin
Clinical Pharmacokinectics, 2000Co-Authors: Christophe Padoin, Olivier PetitjeanAbstract:Isepamicin is an aminoglycoside antibacterial with properties similar to those of amikacin, but with better activity against strains producing type I 6′-acetyltransferase. The antibacterial spectrum includes Enterobacteriaceae and staphylococci. Anaerobes, Neisseriaceae and streptococci are resistant. The lower and upper break-points are 8 and 16 mg/L. Like other aminoglycosides, Isepamicin exhibits a strong concentration-dependent bactericidal effect, a long post-antibiotic effect (several hours) and induces adaptive resistance.
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Clinical Pharmacokinetics and Pharmacodynamics of Isepamicin
Clinical Pharmacokinetics, 2000Co-Authors: Christophe Padoin, Olivier PetitjeanAbstract:Isepamicin is an aminoglycoside antibacterial with properties similar to those of amikacin, but with better activity against strains producing type I 6′-acetyltransferase. The antibacterial spectrum includes Enterobacteriaceae and staphylococci. Anaerobes, Neisseriaceae and streptococci are resistant. The lower and upper break-points are 8 and 16 mg/L. Like other aminoglycosides, Isepamicin exhibits a strong concentration-dependent bactericidal effect, a long post-antibiotic effect (several hours) and induces adaptive resistance. Isepamicin is administered intravenously or intramuscularly at a dosage of 15 mg/kg once daily or 7.5 mg/kg twice daily. Isepamicin is not bound to plasma proteins, and it distributes in extracellular fluids and into some cells (outer hair cells, kidney cortex) by active transport. Isepamicin is not metabolised and is eliminated solely via the renal route with an elimination half-life (t½,β) of 2 to 3 hours in adults with normal renal function. The clearance of Isepamicin is reduced in neonates, and 7.5 mg/kg once daily is recommended in children 40 mg/L to maximise bactericidal efficacy, and a ‘trough’ concentration (at the end of the administration interval)
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clinical pharmacokinetics and pharmacodynamics of Isepamicin
Clinical Pharmacokinectics, 2000Co-Authors: Michel Tod, Christophe Padoin, Olivier PetitjeanAbstract:Isepamicin is an aminoglycoside antibacterial with properties similar to those of amikacin, but with better activity against strains producing type I 6′-acetyltransferase. The antibacterial spectrum includes Enterobacteriaceae and staphylococci. Anaerobes, Neisseriaceae and streptococci are resistant. The lower and upper break-points are 8 and 16 mg/L. Like other aminoglycosides, Isepamicin exhibits a strong concentration-dependent bactericidal effect, a long post-antibiotic effect (several hours) and induces adaptive resistance. Isepamicin is administered intravenously or intramuscularly at a dosage of 15 mg/kg once daily or 7.5 mg/kg twice daily. Isepamicin is not bound to plasma proteins, and it distributes in extracellular fluids and into some cells (outer hair cells, kidney cortex) by active transport. Isepamicin is not metabolised and is eliminated solely via the renal route with an elimination half-life (t½,β) of 2 to 3 hours in adults with normal renal function. The clearance of Isepamicin is reduced in neonates, and 7.5 mg/kg once daily is recommended in children 40 mg/L to maximise bactericidal efficacy, and a ‘trough’ concentration (at the end of the administration interval) <5 mg/L to minimise toxicity. These thresholds should be modified on an individual basis, considering covariates such as concomitant treatment, underlying disease, nature of bacterial strain and site of infection.
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Isepamicin in intensive care unit patients with nosocomial pneumonia: population pharmacokinetic–pharmacodynamic study
Journal of Antimicrobial Chemotherapy, 1999Co-Authors: Michel Tod, G Beaucaire, C. Minozzi, D. Ponsonnet, J. Cougnard, Olivier PetitjeanAbstract:A population approach was used to determine Isepamicin pharmacokinetics in 196 intensive care unit patients treated for nosocomial pneumonia with Isepamicin and a broad-spectrum beta-lactam. Patients were randomized in four groups with respect to the following Isepamicin dosing regimens: (i) 15 mg/kg od for 5 days or (ii) 10 days, (iii) 25 mg/kg on the first day followed by 15 mg/kg od for 4 days or (iv) 9 days. A total of 1489 serum Isepamicin concentrations were measured (median, eight per patient; range, 1-18). Mean +/- S.D. 1 h-peak levels at day 1 were 76 +/- 32 mg/L after the 25 mg/kg dose (n = 85) and 43 +/- 15 mg/L after the 15 mg/kg dose (n = 99). A bicompartmental model was fitted to the data by a mixed-effect modelling approach. Isepamicin clearance was related to age, bodyweight and serum creatinine level. Central volume of distribution was related to bodyweight. Pharmacokinetic parameters were independent of the dosage in the range 15-25 mg/kg and were not different in the patients treated for 5 or 10 days. Bayesian estimates of individual pharmacokinetic parameters were used to calculate various surrogate markers of Isepamicin exposure to be tentatively correlated with clinical outcome and nephrotoxicity. No correlation was found between peak, AUC or their ratio with MIC and clinical efficacy. A weak correlation was found between the increase of serum creatinine level (day 1 versus day 5) and Isepamicin 24 h trough level at day 1 (R2 = 0.10). These data do not favour a systematic therapeutic monitoring of Isepamicin in intensive care unit patients, at least with the doses and antibiotic combinations used in this study.
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Isepamicin in intensive care unit patients with nosocomial pneumonia population pharmacokinetic pharmacodynamic study
Journal of Antimicrobial Chemotherapy, 1999Co-Authors: Michel Tod, G Beaucaire, C. Minozzi, D. Ponsonnet, J. Cougnard, Olivier PetitjeanAbstract:A population approach was used to determine Isepamicin pharmacokinetics in 196 intensive care unit patients treated for nosocomial pneumonia with Isepamicin and a broad-spectrum beta-lactam. Patients were randomized in four groups with respect to the following Isepamicin dosing regimens: (i) 15 mg/kg od for 5 days or (ii) 10 days, (iii) 25 mg/kg on the first day followed by 15 mg/kg od for 4 days or (iv) 9 days. A total of 1489 serum Isepamicin concentrations were measured (median, eight per patient; range, 1-18). Mean +/- S.D. 1 h-peak levels at day 1 were 76 +/- 32 mg/L after the 25 mg/kg dose (n = 85) and 43 +/- 15 mg/L after the 15 mg/kg dose (n = 99). A bicompartmental model was fitted to the data by a mixed-effect modelling approach. Isepamicin clearance was related to age, bodyweight and serum creatinine level. Central volume of distribution was related to bodyweight. Pharmacokinetic parameters were independent of the dosage in the range 15-25 mg/kg and were not different in the patients treated for 5 or 10 days. Bayesian estimates of individual pharmacokinetic parameters were used to calculate various surrogate markers of Isepamicin exposure to be tentatively correlated with clinical outcome and nephrotoxicity. No correlation was found between peak, AUC or their ratio with MIC and clinical efficacy. A weak correlation was found between the increase of serum creatinine level (day 1 versus day 5) and Isepamicin 24 h trough level at day 1 (R2 = 0.10). These data do not favour a systematic therapeutic monitoring of Isepamicin in intensive care unit patients, at least with the doses and antibiotic combinations used in this study.
Rayo Morfin-otero - One of the best experts on this subject based on the ideXlab platform.
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Comparison of the efficacy and safety of Isepamicin and amikacin in the treatment of skin and skin structure infections
Journal of Chemotherapy, 1995Co-Authors: Eduardo Rodríguez-noriega, S. Esparza-ahumada, Rayo Morfin-oteroAbstract:Two hundred and three patients with skin and skin structure infections were treated with Isepamicin once daily or amikacin twice daily in an open, randomised, comparative multicentre trial. Patients were randomised to treatment with Isepamicin or amikacin in a 2 :1 ratio. Severe infections (63 patients) were treated with Isepamicin 15 mg/kg once daily (n=45) or amikacin 7.5 mg/kg twice daily (n=18), less severe infections (140 patients) with Isepamicin 8 mg/kg once daily (n=93) or amikacin 7.5 mg/kg twice daily (n=47). The overall clinical response rate at the end of treatment was excellent in all treatment groups (94-96% cured or improved) with no significant differences between Isepamicin and amikacin in patients with either severe or less severe infections. The most commonly isolated target pathogens were Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis and Staphylococcus aureus. Overall, in patients who had a valid target pathogen isolated prior to treatment and who met other evaluability criteria, bacteriological eradication was achieved in over 90% of patients ; amikacin patients with severe infections had a somewhat lower eradication rate (82%). Over all infections, 4/110 (4%) patients in the Isepamicin group and 5/54 (9%) patients in the amikacin had organisms which persisted. Adverse events were reported in 12% of patients in the Isepamicin group and 6% in the amikacin group. The most frequently reported adverse event in the Isepamicin group was headache. Two patients (one in each treatment group), both of whom experienced skin rashes, were withdrawn. Potentially clinically significant changes in serum creatinine occurred in two patients, who received Isepamicin and one who received amikacin (who was withdrawn from the study). Ototoxicity was rare, occurring in one patient treated with Isepamicin.
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Comparison of the efficacy and safety of Isepamicin and amikacin in the treatment of skin and skin structure infections.
Journal of chemotherapy (Florence Italy), 1995Co-Authors: Eduardo Rodríguez-noriega, S. Esparza-ahumada, Rayo Morfin-oteroAbstract:Two hundred and three patients with skin and skin structure infections were treated with Isepamicin once daily or amikacin twice daily in an open, randomised, comparative multicentre trial. Patients were randomised to treatment with Isepamicin or amikacin in a 2:1 ratio. Severe infections (63 patients) were treated with Isepamicin 15 mg/kg once daily (n = 15) or amikacin 7.5 mg/kg twice daily (n - 18), less severe infections (140 patients) with Isepamicin 8 mg/kg once daily (n = 93) or amikacin 7.5 mg/kg twice daily (n = 47). The overall clinical response rate at the end of treatment was excellent in all treatment groups (94-96% cured or improved) with no significant differences between Isepamicin and amikacin in patients with either server or less severe infections. The most commonly isolated target pathogens were Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis and Staphylococcus aureus. Overall, in patients who had a valid target pathogen isolated prior to treatment and who met other evaluability criteria, bacteriological eradication was achieved in over 90% of patients; amikacin patients with severe infections had a somewhat lower eradication rate (82%). Over all infections, 4/110 (4%) patients in the Isepamicin group and 5/54 (9%) patients in the amikacin had organisms which persisted. Adverse events were reported in 12% of patients in the Isepamicin group and 6% in the amikacin group. The most frequently reported adverse event in the Isepamicin group as headache. Two patients (one in each treatment group), both of whom experienced skin rashes, were withdrawn. Potentially clinically significant changes in serum creatinine occurred in two patients, who received Isepamicin and one who received amikacin (who was withdrawn from the study). Ototoxicity was rare, occurring in one patient treated with Isepamicin.
C. Minozzi - One of the best experts on this subject based on the ideXlab platform.
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Isepamicin in intensive care unit patients with nosocomial pneumonia: population pharmacokinetic–pharmacodynamic study
Journal of Antimicrobial Chemotherapy, 1999Co-Authors: Michel Tod, G Beaucaire, C. Minozzi, D. Ponsonnet, J. Cougnard, Olivier PetitjeanAbstract:A population approach was used to determine Isepamicin pharmacokinetics in 196 intensive care unit patients treated for nosocomial pneumonia with Isepamicin and a broad-spectrum beta-lactam. Patients were randomized in four groups with respect to the following Isepamicin dosing regimens: (i) 15 mg/kg od for 5 days or (ii) 10 days, (iii) 25 mg/kg on the first day followed by 15 mg/kg od for 4 days or (iv) 9 days. A total of 1489 serum Isepamicin concentrations were measured (median, eight per patient; range, 1-18). Mean +/- S.D. 1 h-peak levels at day 1 were 76 +/- 32 mg/L after the 25 mg/kg dose (n = 85) and 43 +/- 15 mg/L after the 15 mg/kg dose (n = 99). A bicompartmental model was fitted to the data by a mixed-effect modelling approach. Isepamicin clearance was related to age, bodyweight and serum creatinine level. Central volume of distribution was related to bodyweight. Pharmacokinetic parameters were independent of the dosage in the range 15-25 mg/kg and were not different in the patients treated for 5 or 10 days. Bayesian estimates of individual pharmacokinetic parameters were used to calculate various surrogate markers of Isepamicin exposure to be tentatively correlated with clinical outcome and nephrotoxicity. No correlation was found between peak, AUC or their ratio with MIC and clinical efficacy. A weak correlation was found between the increase of serum creatinine level (day 1 versus day 5) and Isepamicin 24 h trough level at day 1 (R2 = 0.10). These data do not favour a systematic therapeutic monitoring of Isepamicin in intensive care unit patients, at least with the doses and antibiotic combinations used in this study.
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Isepamicin in intensive care unit patients with nosocomial pneumonia population pharmacokinetic pharmacodynamic study
Journal of Antimicrobial Chemotherapy, 1999Co-Authors: Michel Tod, G Beaucaire, C. Minozzi, D. Ponsonnet, J. Cougnard, Olivier PetitjeanAbstract:A population approach was used to determine Isepamicin pharmacokinetics in 196 intensive care unit patients treated for nosocomial pneumonia with Isepamicin and a broad-spectrum beta-lactam. Patients were randomized in four groups with respect to the following Isepamicin dosing regimens: (i) 15 mg/kg od for 5 days or (ii) 10 days, (iii) 25 mg/kg on the first day followed by 15 mg/kg od for 4 days or (iv) 9 days. A total of 1489 serum Isepamicin concentrations were measured (median, eight per patient; range, 1-18). Mean +/- S.D. 1 h-peak levels at day 1 were 76 +/- 32 mg/L after the 25 mg/kg dose (n = 85) and 43 +/- 15 mg/L after the 15 mg/kg dose (n = 99). A bicompartmental model was fitted to the data by a mixed-effect modelling approach. Isepamicin clearance was related to age, bodyweight and serum creatinine level. Central volume of distribution was related to bodyweight. Pharmacokinetic parameters were independent of the dosage in the range 15-25 mg/kg and were not different in the patients treated for 5 or 10 days. Bayesian estimates of individual pharmacokinetic parameters were used to calculate various surrogate markers of Isepamicin exposure to be tentatively correlated with clinical outcome and nephrotoxicity. No correlation was found between peak, AUC or their ratio with MIC and clinical efficacy. A weak correlation was found between the increase of serum creatinine level (day 1 versus day 5) and Isepamicin 24 h trough level at day 1 (R2 = 0.10). These data do not favour a systematic therapeutic monitoring of Isepamicin in intensive care unit patients, at least with the doses and antibiotic combinations used in this study.
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Population pharmacokinetic study of Isepamicin with intensive care unit patients.
Antimicrobial Agents and Chemotherapy, 1996Co-Authors: Michel Tod, Christophe Padoin, C. Minozzi, J. Cougnard, Olivier PetitjeanAbstract:The pharmacokinetics (PK) of Isepamicin, a new aminoglycoside, were studied in 85 intensive care unit (ICU) patients and were compared with those observed in 10 healthy volunteers. A parametric method based on a nonlinear mixed-effect model was used to assess population PK. Isepamicin was given intravenously over 0.5 h at dosages of 15 mg/kg once daily or 7.5 mg/kg twice daily. The data were fitted to a bicompartmental open model. Compared with healthy volunteers, the mean values of the PK parameters were profoundly modified in ICU patients: elimination clearance was reduced by 48%, the volume of distribution in the central compartment (Vc) was increased by 50%, the peripheral volume of distribution was 70% higher, the distribution clearance was 146% lower, and the elimination half-life was ca. 3.4 times higher. The interindividual variability in PK parameters was about 50% in ICU patients. Five covariates (body weight [BW], simplified acute physiology score [SAPS], temperature, serum creatinine level, and creatinine clearance [CLCR]) were tentatively correlated with PK parameters by multivariate linear regression analysis with stepwise addition and deletion. The variability of Isepamicin clearance was explained by three covariates (BW, SAPS, and CLCR), that of Vc was explained by BW and SAPS, and that of the elimination half-life was explained by CLCR and SAPS. Simulation of the concentration-versus-time profile for 500 individuals showed that the mean peak (0.75 h) concentration was 18% lower in ICU patients than in healthy volunteers and that the range in ICU patients was very broad (28.4 to 95.4 mg/liter). Therefore, monitoring of the Isepamicin concentration is in ICU patients is mandatory.
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Isepamicin once daily plus ceftriaxone versus amikacin plus ceftriaxone in febrile neutropenic patients.
Journal of Chemotherapy, 1995Co-Authors: R Herbrecht, D Blaise, D Espinouse, V Leblond, A Sadoun, C Sauvage, C Cordonnier, C. MinozziAbstract:Isepamicin is a new aminoglycoside with in-vitro activity superior to amikacin. It is a poor substrate for the 6'-aminoacetyltransferase-I enzyme which inactivates amikacin and therefore organisms possessing this enzyme are not resistant to Isepamicin. The aim of this study was to compare the efficacy and safety of co-administration of Isepamicin once daily plus ceftriaxone to amikacin twice daily plus ceftriaxone in febrile neutropenic cancer patients. Febrile episodes in 235 patients (156 in Isepamicin group and 79 in amikacin group) were treated in this study. They occurred in 218 different patients. Fifteen patients were enrolled twice and one three times. Response rates to the two treatment regimens for microbiologically documented episodes, clinically documented episodes and further unexplained fever were similar. Tolerance of the treatment regimens, as measured by serum creatinine levels, hypoaccousia and cutaneous allergy was also similar in both treatment groups. In conclusion, Isepamicin given once daily when combined with ceftriaxone in the treatment of febrile episodes in neutropenic cancer patients was as effective and no more toxic than amikacin.
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Isepamicin once daily plus ceftriaxone versus amikacin plus ceftriaxone in febrile neutropenic patients.
Journal of chemotherapy (Florence Italy), 1995Co-Authors: R Herbrecht, D Blaise, D Espinouse, V Leblond, A Sadoun, C Sauvage, C Cordonnier, C. MinozziAbstract:Isepamicin is a new aminoglycoside with in-vitro activity superior to amikacin. It is a poor substrate for the 6'-aminoacetyltransferase-I enzyme which inactivates amikacin and therefore organisms possessing this enzyme are not resistant to Isepamicin. The aim of this study was to compare the efficacy and safety of co-administration of Isepamicin once daily plus ceftriaxone to amikacin twice daily plus ceftriaxone to amikacin twice daily plus ceftriaxone in febrile neutropenic cancer patients. Febrile episodes in 235 patients (156 in Isepamicin group and 79 in amikacin group) were treated in this study. They occurred in 218 different patients. Fifteen patients were enrolled twice and one three times. Response rates to the two treatment regimens for microbiologically documented episodes, clinically documented episodes and further unexplained fever were similar. Tolerance of the treatment regimens, as measured by serum creatinine levels, hypoaccousia and cutaneous allergy was also similar in both treatment groups. In conclusion, Isepamicin given once daily when combined with ceftriaxone in the treatment of febrile episodes in neutropenic cancer patients was as effective and no more toxic than amikacin.
Kenichi Yamaki - One of the best experts on this subject based on the ideXlab platform.
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Effects of aztreonam in combination with antipseudomonal antibiotics againstPseudomonas aeruginosa isolated from patients with chronic or recurrent lower respiratory tract infection
Journal of Infection and Chemotherapy, 1998Co-Authors: Kenichi Yamaki, Kenzo Takagi, Toshihiko Tanaka, Michio OhtaAbstract:The antipseudomonal activity of aztreonam combined with other antibiotics aas examined in vitro to suggest effective therapeutic combinations for the treatment of respiratory tract infections due to Pseudomonas aeruginosa . Twenty-five P. aeruginosa strains were newly isolated from patients with chronic or recurrent lower respiratory tract infection. The susceptibility of these strains to aztreonam alone and to aztreonam combined with ceftazidime, cefclidin, Isepamicin and imipenem was measured using the checkerboard method. The observed MICs suggested that aztreonam alone was not very potent against P. aeruginosa associated with chronic or recurrent lower respiratory infection, but that cefclidin had strong antipseudomonal activity. The fractionary inhibitory concentration index showed synergy in 60% of the P. aeruginosa clinical isolates with aztreonam plus Isepamicin, and antagonism in approximately 16% of strains with aztreonam plus imipenem. When combined with isepamcin, aztreonam may have potent activity against pseudomonal lower respiratory tract infections.
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effects of aztreonam in combination with antipseudomonal antibiotics against pseudomonas aeruginosa isolated from patients with chronic or recurrent lower respiratory tract infection
Journal of Infection and Chemotherapy, 1998Co-Authors: Kenichi Yamaki, Kenzo Takagi, Toshihiko Tanaka, Michio OhtaAbstract:The antipseudomonal activity of aztreonam combined with other antibiotics aas examined in vitro to suggest effective therapeutic combinations for the treatment of respiratory tract infections due toPseudomonas aeruginosa. Twenty-fiveP. aeruginosa strains were newly isolated from patients with chronic or recurrent lower respiratory tract infection. The susceptibility of these strains to aztreonam alone and to aztreonam combined with ceftazidime, cefclidin, Isepamicin and imipenem was measured using the checkerboard method. The observed MICs suggested that aztreonam alone was not very potent againstP. aeruginosa associated with chronic or recurrent lower respiratory infection, but that cefclidin had strong antipseudomonal activity. The fractionary inhibitory concentration index showed synergy in 60% of theP. aeruginosa clinical isolates with aztreonam plus Isepamicin, and antagonism in approximately 16% of strains with aztreonam plus imipenem. When combined with isepamcin, aztreonam may have potent activity against pseudomonal lower respiratory tract infections.
