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Ceftazidime: a Worldwide Overview As effective as combination therapy of febrile non-neutropenic patients Since 1979, ceftazidime has been given to over 6000 patients in clinical lrials world-wide. 3570 patients have participated in non-comparative trials while 1340 were involved in comparative studies (1179 patients received other antibiotics: aminoglycosides, 14.2%; aminoglycosides pius 1 13-lactam antibacterial, 43%; D- lactams alone, 34%; and others, 8. 8%) , In open studies, ceftazidime therapy resulted in 80.4% bacterial eradication vs 80.6% in comparative trials (other antibacterials were less effective, clearing 72.5% of pathogens from infected sites, p < 0 .0001). Bacterial clearance rates were significantly higher in North American trials compared with European trials. In open vs comparative trials, ceftazidime therapy resulted in cure or improvement in 92 .6 vs 91 .1 % of patients. 84.8% of patients given other antibacterials had posili ve clinical result s, significa ntly less than for ceftazidime therapy. The rate of superinfection following ceftazidime treatment ranged from 2.6-4.2% vs 8.5% for ot her comparative antibacterials (p < 0.005), Superinfections associated with ceftazidime therapy were normally caused by enterococci or fungi. Res istance to ceftazidime developed in 6% of Pseudomonas isolates, 3.9% of Enterobacter sp. and 2.5% overall. Although sensitivity did decrease against these isolates, 54% of patients with infections caused by such pathogens were cured or improved. Addition of an aminoglycoside did not appear to alter the development of resistance. Si de effects occurred in 8.4-10.2% of patients given ceftazidime vs 8.8% of palients treated with other The main adverse effects included gastrointestinal reactions, local intolerance, abnormal liver function results (3 .8-5.7% vs 2.4%, for other antibacterials), abnormal renal function results (1.4-1.7% vs 3.6% lor .other p < 0.02), positive reversible Coombs' test without haemolysis (4 .1·5.4% vs 3.4% for patients given ol her antibacterials) and, in < 1% of ceftazidime·treated patients, thrombocytosis, positive Coombs ' plus haemolysis, neutropenia, leucopenia, decreased haemoglobin values and thrombocytopenia. Ceftazldlme alone appears to be as effective as combinations of two other antibacterials in I he empiric treatment of bacterial infection in non-neutropenic patients. II is also weH tolerated and does not seem to be associated with an increased incidence of resistance or superinfection compared with other antibacterial combinations. Its role in the treatment of febrile neutropenic patients needs further elucidation. Fooro, R.D. American JoomaJ of It4«Iicine 79 (Suppl. 2A}' 110. 113 (Aug 1985) 2 INPHAAMA® 12 0cI 1985 0156.270J/ 85/ 1005-0002/OSOI .00/ 0 0 ADIS Press

Ceftazidime: a Worldwide Overview

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Ceftazidime: a Worldwide Overview As effective as combination therapy of febrile non-neutropenic patients

Since 1979, ceftazidime has been given to over 6000 patients in clinical lrials world-wide . 3570 patients have participated in non-comparative trials while 1340 were involved in comparative studies (1179 patients received other antibiotics: aminoglycosides, 14.2%; aminoglycosides pius ~ 1 13-lactam antibacterial, 43%; D­lactams alone , 34%; and others, 8.8%) ,

In open studies, ceftazidime therapy resulted in 80.4% bacterial eradication vs 80.6% in comparative trials (other antibacterials were less effective, clearing 72.5% of pathogens from infected sites , p < 0 .0001). Bacterial clearance rates were significantly higher in North American trials compared with European trials. In open vs comparative trials, ceftazidime therapy resulted in cure or improvement in 92 .6 vs 91 .1 % of patients. 84.8% of patients given other antibacterials had posilive clinical results, significantly less than for ceftazid ime therapy.

The rate of superinfection following ceftazidime treatment ranged from 2.6-4.2% vs 8.5% for other comparative antibacterials (p < 0.005), Superinfections associated with ceftazidime therapy were normally caused by enterococci or fungi. Resistance to ceftazidime developed in 6% of Pseudomonas isolates , 3.9% of Enterobacter sp. and 2.5% overall. Although sensitivity did decrease against these isolates, 54% of patients with infections caused by such pathogens were cured or improved. Addition of an aminoglycoside did not appear to alter the development of resistance.

Side effects occurred in 8.4-10.2% of patients given ceftazidime vs 8.8% of palients treated with other

ant ib~cterials . The main adverse effects included gastrointestinal reactions, local intolerance, abnormal liver function results (3.8-5.7% vs 2.4%, for other antibacterials), abnormal renal function results (1.4-1.7% vs 3.6% lor .other ~ntibacterials, p < 0.02), positive reversible Coombs ' test without haemolysis (4.1·5.4% vs 3.4% for patients given olher antibacterials) and, in < 1% of ceftazidime·treated patients, thrombocytosis, positive Coombs ' .t~st plus haemolysis, neutropenia, leucopenia, decreased haemoglobin values and thrombocytopenia.

Ceftazldlme alone appears to be as effective as combinations of two other antibacterials in Ihe empiric treatment of bacterial infection in non-neutropenic patients. II is also weH tolerated and does not seem to be associated with an increased incidence of resistance or superinfection compared with other antibacterial combinations. Its role in the treatment of febrile neutropenic patients needs further elucidation. Fooro, R.D. American JoomaJ of It4«Iicine 79 (Suppl. 2A}' 110. 113 (Aug 1985)

2 INPHAAMA® 12 0cI 1985 0156.270J/ 85/ 1005-0002/OSOI.00/ 0 0 ADIS Press