This study demonstrates that azithromycin was comparable to amoxicillin/clavulanate in achieving satisfactory clinical response rates in children with acute otitis media attending day care or school. Azithromycin was significantly better tolerated than amoxicillin/ clavulanate. Parents considered azithromycin to be significantly more convenient to administer and more acceptable to children.

Children with acute otitis media underwent tympanocentesis and were given a single dose of 30 mg of azithromycin/kg of body weight. At day 28, the overall clinical cure rate was 206 of 242 (85%). Clinical cure rates for patients infected with Streptococcus pneumoniae (67 of 76; 88%) and Haemophilus influenzae (28 of 44; 64%) were consistent with historical rates for the 5-day dosing regimen.On pharmacodynamic grounds, it is not the duration but rather the total dose of azithromycin that is predicted to correlate most closely with clinical efficacy (3). For azalides like azithromycin, as for the aminoglycoside and fluoroquinolone classes, the ratio of the area under the concentration-time curve (AUC) to the MIC for the pathogen appears to be the best predictor of efficacy. Based on the principle that greater 24-h AUC values and more rapid bacterial killing would have a favorable impact on the emergence of resistance, as well as on the likelihood of improved patient adherence, a study was undertaken to examine the efficacy of a single oral dose of 30 mg of azithromycin/kg of body weight in the treatment of acute otitis media in children.Children were eligible for enrollment if they demonstrated one or more signs or symptoms of acute otitis media, including ear pain or fullness, discharge from the external auditory canal, decreased hearing, or fever. They must also have had one or more of the following: bulging or marked erythema of the tympanic membrane, loss of the normal light reflex or tympanic membrane landmarks, or impaired tympanic mobility on biphasic pneumatic otoscopy. The effusion was to be documented by acoustic reflectometry (8) with an abnormal reading of 3 or higher. Patients were excluded if they had a history of hypersensitivity to macrolides or azithromycin, had been treated with antibiotics in the previous 30 days, had symptoms of otitis media for longer than 4 weeks, had tympanostomy tubes present, or had been receiving antimicrobial prophylaxis. The institutional review board of each participating center reviewed and approved participation in the trial. Written informed consent was obtained for each patient.Samples of middle ear fluid were obtained either by tympanocentesis or, in the case of a perforated tympanic membrane, with a swab. Patients then received 30 mg of azithromycin/kg in a single oral dose. Children who vomited within 30 min of dosing were redosed.The samples of middle ear fluid were split for storage at a central laboratory and cultured locally. All pathogens isolated locally were subcultured and sent to a central laboratory (MDS Clinical Trial Laboratories) for confirmation and susceptibility testing. Phone contact with each patient occurred on study day 5 for assessment of adverse events; this was followed by visits on days 10 and 24 to 28, at which time detailed clinical assessments regarding clinical cure (complete resolution of all signs and symptoms of acute otitis media), improvement, or failure were made. Any patient who was considered to have failed therapy was to have...

Of 107 gram-negative isolates obtained from intensive care units examined for patterns of multiresistance to 16 antimicrobial agents, 54.2% were multiresistant, defined as resistant to three or more test antimicrobials. Ciprofloxacin had excellent activity against all isolates with 93.4% susceptibility. Ciprofloxacin also performed well on multiresistant isolates with 89.7% susceptibility, which included 42.2% inducible Enterobacteriaceae. All six multiresistant ciprofloxacin-resistant isolates were resistant to five or more of the tested antimicrobials (mean 9.0), including a highly resistant Proteus mirabilis urine isolate resistant to 14 of 16 agents. The only antimicrobial to which all of the ciprofloxacin-multi-resistant isolates were resistant, was ampicillin, indicating an absence of cross resistance. In addition, ciprofloxacin had excellent activity (100% susceptibility) against Enterobacter spp. and Klebsiella pneumoniae, two organisms frequently associated with nosocomial infections.

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