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Cefaclor compared with amoxycillin acute otitis media with effusion: a preliminary report
Insights
Cefaclor shows promise in treating acute otitis media with effusion (OME) in children, with all tested pathogens sensitive in vitro. This study highlights potential against ampicillin-resistant bacteria, suggesting a valuable new antimicrobial option for middle ear infections.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Pharmacology
Background:
- Acute otitis media with effusion (OME) is a common pediatric condition.
- Bacterial resistance to standard antibiotics like ampicillin is a growing concern.
- Effective treatment options for OME are crucial to prevent complications.
Purpose of the Study:
- To compare the efficacy of cefaclor and amoxycillin in treating acute otitis media with effusion (OME) in infants and children.
- To evaluate the in vitro sensitivity of middle ear pathogens to cefaclor.
- To assess the clinical response and effusion persistence in children with OME.
Main Methods:
- A double-blind, randomized clinical trial was conducted.
- 55 infants and children with acute OME were enrolled.
- Tympanocentesis was performed for culture and sensitivity testing.
Main Results:
- All isolated pathogens (including ampicillin-resistant strains of Haemophilus influenzae and Staphylococcus aureus) were sensitive in vitro to cefaclor.
- An excellent initial symptomatic response was observed in 88% of subjects within 2 weeks.
- Middle ear effusion persisted in 48% of ears at 6 weeks, with tympanocentesis showing no significant impact on clinical response or effusion persistence.
Conclusions:
- Cefaclor demonstrates promising in vitro activity against common pathogens causing OME, including resistant strains.
- The study suggests cefaclor may be a valuable alternative antimicrobial for treating OME, especially in cases involving ampicillin-resistant bacteria.
- Further research is warranted to confirm the clinical efficacy and role of cefaclor in OME management.
Abstract:
A double-blind, randomized clinical trial comparing cefaclor with amoxycillin in the treatment of acute otitis media with effusion (OME) in infants and children is being conducted at Children's Hospital of Pittsburgh. Although the randomization code has not yet been broken, the results of treating the first 55 children are reported, since they appear to be of interest. Of the 62 ears with acute OME on which an initial tympanocentesis was performed, 41 positive cultures were isolated from the middle ear aspirates. Of the 10 ears from which Haemophilus influenzae was isolated, one had a type b strain, and of the remaining unencapsulated strains, one was resistant to both penicillin G and ampicillin. In the one ear from which Staphylococcus aureus was isolated, the organism was found to be resistant to ampicillin. However, all of the organisms were sensitive in vitro to cefaclor. In 88% of all subjects observed for the first 2 weeks, the initial symptomatic response was excellent. Six children had persistent signs and symptoms of acute OME and received a second tympanocentesis; however, none of the effusions from the repeat aspiration revealed an organism. An effusion was still present in 97% of the ears after 3 days, in 69% after 2 weeks, and in 48% 6 weeks after initiation of the study. Tympanocentesis did not appear to affect either the initial clinical response or the persistence of effusion. There were no adverse reactions to either drug in this study. Because an apparent increase in the incidence of ampicillin-resistant strains of H. influenzae is being reported, and because of the presence of ampicillin-resistant S. aureus in some ears with acute OME, a new antimicrobial effective against all the common pathogens causing acute middle ear disease would be desirable. In this respect, the preliminary findings of treatment with cefaclor from this study appear promising.