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Five-day twice daily cefdinir therapy for acute otitis media: microbiologic and clinical efficacy
S L Block1, J A Hedrick, J Kratzer
1Kentucky Pediatric Research, Bardstown, USA.
Objective:
To examine the microbiologic and clinical efficacy of a 5-day course of cefdinir in the treatment of tympanocentesis-documented acute otitis media (AOM).
Design:
Open label noncomparative trial.
Setting:
Primary care, ambulatory.
Patients:
Children ages 6 months through 12 years with signs of AOM and middle ear effusion confirmed by tympanometry in at least one ear.
Intervention:
Patients underwent tympanocentesis at baseline and received cefdinir 7 mg/kg twice a day for 5 days.
Main Outcome Measures:
Presumptive eradication of middle ear pathogens determined by clinical cure of signs and symptoms of AOM at end of therapy (Study Days 7 to 9) and Visit 3 (Study Days 16 to 21).
Results:
A total of 125 of 177 enrolled children had 134 pathogens isolated by tympanocentesis: Streptococcus pneumoniae, 69 (51.5%); Haemophilus influenzae 44 (32.8%; beta-lactamase-positive in 18 of 44 strains); beta-lactamase-positive Moraxella catarrhalis, 15 (11.2%); and Streptococcus pyogenes, 6 (4.5%). The clinical cure rates by patient in the microbiologically and overall clinically evaluable groups, respectively, were 73% (84 of 115) and 77.4% (130 of 168) at the end of therapy visit and 57.4% (66 of 115) and 61.9% (104 of 168) at Visit 3. Presumptive eradication rates at end of therapy were 8 of 11 (72.7%) and 4 of 8 (50%) for patients with penicillin-intermediate and -resistant S. pneumoniae isolates, respectively. Adverse reactions occurred in 16% of patients, with diarrhea (11%) occurring most frequently.
Conclusions:
A 5-day regimen of cefdinir was effective in the eradication of the common causative pathogens of nonrefractory AOM, including intermediate penicillin-resistant S. pneumoniae and beta-lactamase-producing organisms. Cefdinir should be considered a suitable second line antibiotic for AOM.
Insights
A 5-day course of cefdinir effectively treated acute otitis media (AOM) in children, eradicating common pathogens including resistant strains. This antibiotic shows promise as a second-line treatment for AOM.
Area of Science:
- Infectious Diseases
- Pediatrics
- Microbiology
Background:
- Acute otitis media (AOM) is a common childhood infection often caused by bacteria like Streptococcus pneumoniae.
- Antibiotic resistance is a growing concern in AOM treatment, necessitating evaluation of alternative therapies.
- Cefdinir, a third-generation cephalosporin, has demonstrated efficacy against common AOM pathogens.
Purpose of the Study:
- To assess the clinical and microbiologic effectiveness of a 5-day cefdinir regimen for treating AOM.
- To evaluate cefdinir's efficacy against specific pathogens, including penicillin-resistant Streptococcus pneumoniae and beta-lactamase-producing organisms.
- To determine cefdinir's suitability as a second-line antibiotic for AOM.
Main Methods:
- An open-label, noncomparative trial was conducted in a primary care setting.
- Children aged 6 months to 12 years with tympanocentesis-documented AOM were enrolled.
- Patients received cefdinir 7 mg/kg twice daily for 5 days, with clinical and microbiologic assessments.
Main Results:
- The study identified Streptococcus pneumoniae (51.5%), Haemophilus influenzae (32.8%), and Moraxella catarrhalis (11.2%) as primary pathogens.
- Clinical cure rates at the end of therapy were 73% (microbiologically evaluable) and 77.4% (clinically evaluable).
- Presumptive eradication rates for penicillin-intermediate and -resistant S. pneumoniae were 72.7% and 50%, respectively. Diarrhea was the most common adverse reaction (11%).
Conclusions:
- A 5-day cefdinir regimen is effective in eradicating common AOM pathogens, including resistant strains.
- Cefdinir demonstrates efficacy against intermediate penicillin-resistant S. pneumoniae and beta-lactamase-producing organisms.
- Cefdinir is a viable second-line antibiotic option for managing acute otitis media.
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