The Journal of International Medical Research 1990; 18: 228 - 234
Cefetamet in the Treatment of Acute Sinusitis in Adult Patients u. Gauger" P. Inoka', G. Germano' and M. Kissling" 'Steinerstrasse 4,70 Munich, FRG; 2Karlsplatz 3,8000 Munich, FRG; "Clinical Research, F. Hoffmann - La Roche Ltd, Basel, Switzerland
Cefetamet, an oral third-generation cephalosporin, was investigated in a prospective, randomized, open, comparative trial in 41 outpatients with acute sinusitis. The efficacy of 500 mg cefetamet given orally twice daily for 7 days to 22 patients was compared with that of 500 mg cefaclor given orally three times daily for 7 days to 19 patients. Sinus punctures were performed" before antimicrobial therapy in 10 patients from each treatment group. A successful bacteriological response was obtained in all the 21 assessable patients treated with cefetamet and in the cefaclor-treated group 18 assessable patients were cured and two were improved, but one failed to respond to therapy. The tolerability of both drugs was good and no withdrawals from treatment were necessary. KEY WORDS: Cefetamet; cefaclor; cephelosporin; acute sinusitis.
INTRODUCTION
efetamet, an oral cephalosporin of the third generation, has high bactericidal activity against a range of pathogens causing sinusitis. The minimal concentration that is inhibitoryto 90% of organisms(MIC 23 mm or < 4 ug/ml; intermediate strains, 17 - 22 mm or 8 - 16 ug/ml; and resistant pathogens, < 16 mm or > 16 ~g/ml. A bacteriological cure was achieved if the causative agent was eliminated after completion of treatment and during the follow-up period of 1 week after the completion of treatment. The treatment was considered a failure if clinical findings did not subside and the primary isolated pathogen was not eradicated during therapy, or if a relapse occurred during the follow-up period. An improvement of the patient's condition meant that the clinical findings showed incomplete resolution of clinical evidence of the infection. The patient's response to therapy could not be evaluated if the patient did not come to the scheduled control visits, or if an underlying condition obscured the clinical judgement. In the assessment of the overall clinical outcome, clinical signs and symptoms, such as body temperature, headache, facial pain, nasal discharge and pharyngeal discharge, were considered at the end of treatment and at the follow-up visit. Systemictolerabilitywasmonitoreddaily during treatment by direct questioning of the patient, and routine haematology and serum chemistry (renal and kidney function tests) tests, as well as urinalyses, were performed before, during and after administration of the trial drugs.
229
w
tv
0
64
40 39
39 50 46
F
F F
M M M
F F F
F
9
10
14
15 16 17
18 19
12 13
11
58
33
M
M
F F F
61 30
45 52 36
29 53
64
99 85
62 63 66
68
72
84
66
66 72
85 79 61 60
72
66
M M M M
1 2 3 4 5 6 7 8
28 30 41 50 23
Sex'
Patient
Age Weight (years) (kg)
Cefetamet Cefrtamet
Cefetamet Cefaclor Cefaclor
Cefetamet Cefetamet Cefaclor
Cefetamet Cefetamet
Cefaclor
Cefetamet Cefaclor Cefaclor Cefaclor Cefetamet Cefetamet Cefaclor Cefaclor
Test drug
Cured Cured
Cured Cured Cured
Cured Cured Cured
Cured Cured
Cured
Not assessable Cured Not 'assessable Improved Cured Cured Cured Cured
Overall outcome
twice daily or 500 mg cefaclor three times daily for 7 days
Strep. pneumoniae + H. injluenzae H. injluenzae Strep. pneumoniae Proteus mirabilis + Klebsiella oxytoca
Strep. pneumoniae + Haemophilus injluenzae Strep. pneumoniae
Streptococcal ~haemolytic group A Pseudomonas aeruginosa + Acinetobacter calcoaceticus
Strep. pneumoniae
Steptococcus pneumonia
Pretreatment
Post-treatment
No material No material No material
No material No material No material
No material
No material
No material
Strep. pneumoniae
Isolated pathogens
Tiredness None
None None None
None None None
None None
None
None None None None None None None None
Adverse events
Table 1 Summary of pathogens isolated and adverse events recorded in patients with acute sinusitis treated orally with 500 mg cefetamet
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Cefetamet in the Treatment of Acute Sinusitis in Adult Patients u. Gauger" P. Inoka', G. Germano' and M. Kissling" 'Steinerstrasse 4,70 Munich, FRG; 2Karlsplatz 3,8000 Munich, FRG; "Clinical Research, F. Hoffmann - La Roche Ltd, Basel, Switzerland
Cefetamet, an oral third-generation cephalosporin, was investigated in a prospective, randomized, open, comparative trial in 41 outpatients with acute sinusitis. The efficacy of 500 mg cefetamet given orally twice daily for 7 days to 22 patients was compared with that of 500 mg cefaclor given orally three times daily for 7 days to 19 patients. Sinus punctures were performed" before antimicrobial therapy in 10 patients from each treatment group. A successful bacteriological response was obtained in all the 21 assessable patients treated with cefetamet and in the cefaclor-treated group 18 assessable patients were cured and two were improved, but one failed to respond to therapy. The tolerability of both drugs was good and no withdrawals from treatment were necessary. KEY WORDS: Cefetamet; cefaclor; cephelosporin; acute sinusitis.
INTRODUCTION
efetamet, an oral cephalosporin of the third generation, has high bactericidal activity against a range of pathogens causing sinusitis. The minimal concentration that is inhibitoryto 90% of organisms(MIC 23 mm or < 4 ug/ml; intermediate strains, 17 - 22 mm or 8 - 16 ug/ml; and resistant pathogens, < 16 mm or > 16 ~g/ml. A bacteriological cure was achieved if the causative agent was eliminated after completion of treatment and during the follow-up period of 1 week after the completion of treatment. The treatment was considered a failure if clinical findings did not subside and the primary isolated pathogen was not eradicated during therapy, or if a relapse occurred during the follow-up period. An improvement of the patient's condition meant that the clinical findings showed incomplete resolution of clinical evidence of the infection. The patient's response to therapy could not be evaluated if the patient did not come to the scheduled control visits, or if an underlying condition obscured the clinical judgement. In the assessment of the overall clinical outcome, clinical signs and symptoms, such as body temperature, headache, facial pain, nasal discharge and pharyngeal discharge, were considered at the end of treatment and at the follow-up visit. Systemictolerabilitywasmonitoreddaily during treatment by direct questioning of the patient, and routine haematology and serum chemistry (renal and kidney function tests) tests, as well as urinalyses, were performed before, during and after administration of the trial drugs.
229
w
tv
0
64
40 39
39 50 46
F
F F
M M M
F F F
F
9
10
14
15 16 17
18 19
12 13
11
58
33
M
M
F F F
61 30
45 52 36
29 53
64
99 85
62 63 66
68
72
84
66
66 72
85 79 61 60
72
66
M M M M
1 2 3 4 5 6 7 8
28 30 41 50 23
Sex'
Patient
Age Weight (years) (kg)
Cefetamet Cefrtamet
Cefetamet Cefaclor Cefaclor
Cefetamet Cefetamet Cefaclor
Cefetamet Cefetamet
Cefaclor
Cefetamet Cefaclor Cefaclor Cefaclor Cefetamet Cefetamet Cefaclor Cefaclor
Test drug
Cured Cured
Cured Cured Cured
Cured Cured Cured
Cured Cured
Cured
Not assessable Cured Not 'assessable Improved Cured Cured Cured Cured
Overall outcome
twice daily or 500 mg cefaclor three times daily for 7 days
Strep. pneumoniae + H. injluenzae H. injluenzae Strep. pneumoniae Proteus mirabilis + Klebsiella oxytoca
Strep. pneumoniae + Haemophilus injluenzae Strep. pneumoniae
Streptococcal ~haemolytic group A Pseudomonas aeruginosa + Acinetobacter calcoaceticus
Strep. pneumoniae
Steptococcus pneumonia
Pretreatment
Post-treatment
No material No material No material
No material No material No material
No material
No material
No material
Strep. pneumoniae
Isolated pathogens
Tiredness None
None None None
None None None
None None
None
None None None None None None None None
Adverse events
Table 1 Summary of pathogens isolated and adverse events recorded in patients with acute sinusitis treated orally with 500 mg cefetamet
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