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A comparison of 5 days of therapy with cefdinir or azithromycin in children with acute otitis media: a multicenter, prospective, single-blind study.
Clin Ther 2005; 27(6):786-94CT

Abstract

BACKGROUND

Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance.

METHODS

In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7-9) and the follow-up visit (days 20-25).

RESULTS

Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae. At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, -5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, -6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, -18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (< or = 7% each).

CONCLUSIONS

Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.

Authors+Show Affiliations

Kentucky Pediatric/Adult Research, Bardstown, 40004, USA. slblock@pol.netNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16117986

Citation

Block, Stan L., et al. "A Comparison of 5 Days of Therapy With Cefdinir or Azithromycin in Children With Acute Otitis Media: a Multicenter, Prospective, Single-blind Study." Clinical Therapeutics, vol. 27, no. 6, 2005, pp. 786-94.
Block SL, Cifaldi M, Gu Y, et al. A comparison of 5 days of therapy with cefdinir or azithromycin in children with acute otitis media: a multicenter, prospective, single-blind study. Clin Ther. 2005;27(6):786-94.
Block, S. L., Cifaldi, M., Gu, Y., & Paris, M. M. (2005). A comparison of 5 days of therapy with cefdinir or azithromycin in children with acute otitis media: a multicenter, prospective, single-blind study. Clinical Therapeutics, 27(6), pp. 786-94.
Block SL, et al. A Comparison of 5 Days of Therapy With Cefdinir or Azithromycin in Children With Acute Otitis Media: a Multicenter, Prospective, Single-blind Study. Clin Ther. 2005;27(6):786-94. PubMed PMID: 16117986.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparison of 5 days of therapy with cefdinir or azithromycin in children with acute otitis media: a multicenter, prospective, single-blind study. AU - Block,Stan L, AU - Cifaldi,Mary, AU - Gu,Yihua, AU - Paris,Maria M, PY - 2005/04/01/accepted PY - 2005/8/25/pubmed PY - 2006/6/1/medline PY - 2005/8/25/entrez SP - 786 EP - 94 JF - Clinical therapeutics JO - Clin Ther VL - 27 IS - 6 N2 - BACKGROUND: Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance. METHODS: In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7-9) and the follow-up visit (days 20-25). RESULTS: Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae. At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, -5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, -6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, -18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (< or = 7% each). CONCLUSIONS: Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/16117986/A_comparison_of_5_days_of_therapy_with_cefdinir_or_azithromycin_in_children_with_acute_otitis_media:_a_multicenter_prospective_single_blind_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(05)00105-0 DB - PRIME DP - Unbound Medicine ER -