Abstract | OBJECTIVE: METHODS: This was an investigator-blinded, randomized, comparative, multicenter trial, in which tympanocentesis was performed in 384 patients, ages 6 months to 12 years, who had nonrefractory AOM. Patients were randomized to receive one of three 10-day treatment regimens: cefdinir 14 mg/kg daily (QD; n = 128); cefdinir 7 mg/kg twice a day (BID; n = 128); or amoxicillin/ clavulanate 40/10 mg/kg/day divided for use three times a day (TID; n = 128). RESULTS: Of the 384 enrolled patients 303 were evaluable for clinical efficacy. Clinical success rates were statistically equivalent for the 3 treatment groups at the end of therapy: 85 of 102 (83.3%) for cefdinir QD; 81 of 101 (80.2%) for cefdinir BID; 86 of 100 (86%) for amoxicillin/ clavulanate. Of the 197 evaluable patients from whom a susceptible pathogen was recovered, presumptive eradication rates at end of therapy were equivalent: 55 of 65 (84.6%), 54 of 66 (81.8%) and 55 of 66 (83.3%) for cefdinir QD-, cefdinir BID- and amoxicillin/ clavulanate-treated patients, respectively. However, presumptive eradication rates for Streptococcus pneumoniae were significantly lower for cefdinir BID (55.2%) than for amoxicillin/ clavulanate (89.5%; P = 0.0019) and marginally lower than for cefdinir QD (80%; P = 0.054). Diarrhea was the most common treatment-associated adverse reaction in all groups but was significantly more common in amoxicillin/ clavulanate-treated patients (35%) than in patients who had been treated with cefdinir QD (10%, P<0.001) or cefdinir BID (13%, P<0.001). CONCLUSIONS: A 10-day regimen of cefdinir 14 mg/kg QD or 7 mg/kg BID was as clinically effective overall as a 10-day regimen of amoxicillin/ clavulanate 40/10 mg/kg/day divided TID in the treatment of tympanocentesis-confirmed, nonrefractory AOM in children. These data suggest that cefdinir QD may be a better alternative than cefdinir BID for refractory AOM. Both dosing regimens of cefdinir were associated with significantly fewer gastrointestinal adverse reactions than was amoxicillin/ clavulanate.
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Authors | S L Block, J M McCarty, J A Hedrick, M A Nemeth, C H Keyserling, K J Tack, Cefdinir Otitis Media Study Group |
Journal | The Pediatric infectious disease journal
(Pediatr Infect Dis J)
Vol. 19
Issue 12 Suppl
Pg. S159-65
(Dec 2000)
ISSN: 0891-3668 [Print] United States |
PMID | 11144398
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Cephalosporins
- Amoxicillin-Potassium Clavulanate Combination
- Cefdinir
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Topics |
- Acute Disease
- Amoxicillin-Potassium Clavulanate Combination
(therapeutic use)
- Cefdinir
- Cephalosporins
(therapeutic use)
- Child
- Child, Preschool
- Drug Therapy, Combination
(therapeutic use)
- Female
- Humans
- Infant
- Male
- Otitis Media, Suppurative
(drug therapy)
- Treatment Outcome
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