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Pharmacokinetics of cefaclor in chronic middle ear effusions
Insights
Cefaclor antibiotic levels were measured in children with middle ear effusion. Detectable cefaclor concentrations were found in the middle ear fluid after oral administration, aiding in understanding antibiotic efficacy for otitis media treatment.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacokinetics
- Otolaryngology
Background:
- Chronic or recurrent otitis media with effusion (OME) is common in children.
- Tympanostomy tube insertion is a frequent treatment for persistent OME.
- Understanding antibiotic penetration into middle ear fluid is crucial for effective treatment.
Purpose of the Study:
- To determine serum and middle ear fluid concentrations of cefaclor in children with OME.
- To assess the correlation between cefaclor levels and effusion type.
- To identify bacterial pathogens in middle ear effusions.
Main Methods:
- Fifty children (1-13 years) with OME received oral cefaclor (15 mg/kg) before tympanostomy tube insertion.
- Serum and middle ear aspirate samples were collected for cefaclor concentration analysis using microbiological assay (disk diffusion).
- Middle ear fluid cultures were performed to identify aerobic bacteria.
Main Results:
- Mean peak serum cefaclor concentration was 8.49 µg/ml at 30 minutes; mean peak middle ear fluid concentration was 0.47 µg/ml at 1 hour.
- Cefaclor was detectable (>0.16 µg/ml) in 37 of 87 middle ear specimens.
- No correlation was found between effusion type (mucoid/serous) and cefaclor concentration.
- Eighteen percent of middle ear cultures were positive for aerobic bacteria, with *Hemophilus influenzae* being most common.
Conclusions:
- Oral cefaclor achieves detectable concentrations in middle ear effusions of children undergoing tympanostomy tube insertion.
- These findings support the use of cefaclor for treating OME, though further studies on clinical efficacy are warranted.
- Bacterial pathogens, primarily *Hemophilus influenzae*, are present in a minority of OME cases.
Abstract:
Fifty children aged 1 to 13 years with chronic or recurrent otitis media with effusion received a single dose of cefaclor (15 mg/kg body weight) by the oral route 30 minutes to seven hours before the removal of middle ear effusion and insertion of tympanostomy tubes. Serum and middle ear aspirate concentrations of the antibiotic were determined employing a microbiological assay technique by a disk diffusion method. Middle ear specimens were also cultured for aerobic bacteria. The mean peak serum concentration level (8.49 +/- 7.89 micrograms/ml) was observed after 30 minutes, whereas the middle ear peak level (0.47 +/- 0.78 micrograms/ml) occurred after one hour. Of the 87 middle ear specimens, 37 had cefaclor concentrations which were detectable within the resolution of the bioassay method (greater than 0.16 micrograms/ml). There was no correlation between the type of middle ear effusion (mucoid or serous) and the concentration of cefaclor in the middle ear. Only 18% of the middle ear cultures were positive for aerobic bacteria; Hemophilus influenzae was the most common organism.