Comparison of cefpodoxime proxetil and cefixime in the treatment of acute otitis media in infants and children. Otitis Study Group.
OBJECTIVE
To compare the use of once-a-day cefpodoxime proxetil to once-a-day cefixime in the treatment of acute suppurative otitis media.


METHODS
Randomized, multicenter, investigator-blinded.


METHODS
Outpatient.


METHODS
A total of 368 patients (age 2 months to 17 years) were randomized to receive either cefpodoxime or cefixime in a 2:1 ratio (245 cefpodoxime, 123 cefixime); 236 patients (155 cefpodoxime, 81 cefixime) were evaluable for drug efficacy.


METHODS
Patients received either cefpodoxime proxetil oral suspension (10 mg/kg/day, once daily for 10 days) or cefixime oral suspension (8 mg/kg/day, once daily for 10 days).


METHODS
Clinical evaluations were performed before treatment (study day 1), at an interim visit (study day 3 through 6), at the end of therapy (study day 12 through 15), and at final follow-up (study day 25 through 38). Microbiologic evaluations were performed at enrollment and whenever appropriate thereafter.


RESULTS
End-of-therapy clinical cure rates in evaluable patients were 56% for the cefpodoxime group and 54% for the cefixime group. Clinical improvement rates were 27% for both groups. Clinical response rates were not significantly different between treatment groups (P = .541; 95% confidence interval = -8.1%, 15.2%). At long-term follow-up, 17% of patients in the cefpodoxime group and 20% in the cefixime group had a recurrence of infection. Drug-related adverse events (eg, diarrhea, diaper rash, vomiting, rash) occurred in 23.3% of cefpodoxime-treated patients and 17.9% of cefixime-treated patients (P = .282).


CONCLUSIONS
These findings suggest that cefpodoxime proxetil administered once daily is as effective and safe as cefixime given once daily in the treatment of acute suppurative otitis media in pediatric patients.
Asmar
B I
BI
Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan.
Dajani
A S
AS
Del Beccaro
M A
MA
Mendelman
P M
PM
D000208:Acute Disease; D000293:Adolescent; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020682:Cefixime; D002439:Cefotaxime / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D015296:Ceftizoxime / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D010035:Otitis Media, Suppurative / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D011355:Prodrugs / Q000008:administration & dosage* / Q000009:adverse effects; D013223:Statistics as Topic; D016896:Treatment Outcome; D000097627:Cefpodoxime Proxetil
D000890:Anti-Infective Agents; D020682:Cefixime; D002439:Cefotaxime; D015296:Ceftizoxime; D011355:Prodrugs; D000097627:Cefpodoxime Proxetil