Comparative efficacies of erythromycin-sulfisoxazole and cefaclor in acute otitis media: a double blind randomized trial.
A prospective double blind trial compared the fixed combination of erythromycin-sulfisoxazole (E/S) with cefaclor in the treatment of acute otitis media. One hundred nineteen children in six centers across Canada were studied. Diagnostic tympanocentesis of 134 ears yielded 135 bacterial isolates: Streptococcus pneumoniae (42%); Haemophilus influenzae (21%); Branhamella catarrhalis (10%); Streptococcus pyogenes (5%); and other bacteria (22%). Seventy-seven percent of strains of B. catarrhalis and 14% of strains of H. influenzae were beta-lactamase producers. E/S exhibited greater in vitro activity against H. influenzae and B. catarrhalis. Twenty-three patients had bacteriologically sterile middle ear fluid. The overall clinical outcome at Days 10 and 31 was identical in both treatment groups. Otoscopic findings improved more rapidly in the E/S group than in the cefaclor group at 10 and 31 days (P less than or equal to 0.04). In cases where pre-treatment middle ear fluid was negative on routine bacterial culture, complete cure at 10 days was observed in 75% of patients treated with E/S but only in 14% of those treated with cefaclor (P = 0.02). Side effects were infrequent and comparable between the test drugs. E/S is at least as effective as cefaclor in the management of acute otitis media and may be superior, particularly for cases not yielding bacteria on routine culture.
Bergeron
M G
MG
Ahronheim
G
G
Richard
J E
JE
Riding
K
K
Cron
C
C
Bryer
D
D
Macdonald
N
N
Bouchard
M
M
Young
J
J
Dempsey
E E
EE
D000208:Acute Disease; D000293:Adolescent; D000667:Ampicillin / Q000494:pharmacology; D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002433:Cefaclor / Q000494:pharmacology / Q000627:therapeutic use*; D002506:Cephalexin / Q000031:analogs & derivatives*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004338:Drug Combinations / Q000494:pharmacology / Q000627:therapeutic use; D004917:Erythromycin / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006193:Haemophilus influenzae / Q000187:drug effects / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D009016:Moraxella / Q000187:drug effects / Q000302:isolation & purification; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D011897:Random Allocation; D012008:Recurrence; D013296:Streptococcus pneumoniae / Q000187:drug effects / Q000302:isolation & purification; D013444:Sulfisoxazole / Q000494:pharmacology / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D004917:Erythromycin; D002433:Cefaclor; D013444:Sulfisoxazole; D000667:Ampicillin; C041478:MK 0641; D002506:Cephalexin