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A Double-blind, Multiple-Dose Comparative Study

William J. Rodriguez, MD, PhD; Richard H. Schwartz, MD; Tahir Sait, MD; Waheed N. Khan, PhD; Om P. Chhabra, MD; Margan J. Chang, MD; Soma Reddy, MD; Lloyd A. Marks, MD; A. Jack Gold, MD

Am J Dis Child. 1985;139(8):766-770.

Abstract
• A fixed combination of erythromycin ethylsuccinate and sulfisoxazole acetyl (erythromycin-sulfa) was compared with amoxicillin for the treatment of acute otitis media (AOM) in children. Of 145 patients studied, 76 boys and 69 girls were compliant and were evaluated for drug efficacy (72 amoxicillin, 73 erythromycin-sulfa). Based on otoscopic and tympanometric results, cure rates at ten to 14 days for AOM due to all organisms were 83% (63/72) for amoxicillin and 89% (65/73) for erythromycinsulfa; for Haemophilus species (including mixed infections), they were 84% for amoxicillin (26/31) and 83% for erythromycin-sulfa (20/14). Cure rates for ampicillin-resistant Haemophilus were 1/1 for amoxicillin and 7/8 (88%) for erythromycin-sulfa; one patient (12%) had persistent AOM at day 10. Of the patients with AOM due to Streptococcus pneumoniae, 82% (29/35) in the amoxicillin-treated group and 98% (39/40) in the erythromycin-sulfa–treated group were cured. Patients with S pneumoniae as the initial infecting organism who were treated with amoxicillin had significantly more clinical recurrences then their erythromycin-sulfa–treated counterparts, 66% (8/12) vs 33% (3/9). There was no difference between treatment groups in recurrence rates for patients with Haemophilus as the initial infecting organism. On the treatment day indicated, the following number of patients had middle ear effusion: by days 10 to 14, 38% (27/72) amoxicillin-treated patients and 48% (35/73) erythromycin-sulfa–treated patients; by day 28,10% (7/71) amoxicillin-treated patients and 16% (11/70) erythromycin-sulfa–treated patients. There were no significant differences in adverse reactions. The erythromycin-sulfa combination is safe and effective treatment for AOM, including ampicillin-resistant Haemophilus.

(AJDC 1985;139:766-770)

Author Affiliations
From the Department of Infectious Diseases and Microbiology Research, Children's Hospital National Medical Center (Drs Rodriguez, Khan, Chang, and Marks) and the Department of Child Health and Development, George Washington University School of Medicine (Drs Rodriguez, Schwartz, and Chang), Washington, DC. Dr Schwartz is also in private practice in Vienna, Va; Drs Sait, Chhabra, and Reddy are in private practice in Waldorf, Md. Dr Gold is with Ross Laboratories, Columbus, Ohio.

Footnotes
Reprint requests to 111 Michigan Ave NW, Washington, DC 20010 (Dr Rodriguez).

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