A randomized, multicenter, double blind, double dummy trial of single dose azithromycin versus high dose amoxicillin for treatment of uncomplicated acute otitis media.

BACKGROUND: High dose amoxicillin is recommended for the initial treatment of children with acute otitis media (AOM), particularly patients at risk for having drug-resistant Streptococcus pneumoniae. Single dose azithromycin (30 mg/kg) is considered an alternative agent for the treatment of AOM. OBJECTIVE: To compare the clinical efficacy and safety of single dose azithromycin with that of high dose amoxicillin among children with uncomplicated AOM. METHODS: This was a double blind, double dummy, multinational, clinical trial in which children (6-30 months of age) with AOM were randomized to treatment with single dose azithromycin (30 mg/kg) or high dose amoxicillin (90 mg/kg/d, in 2 divided doses) for 10 days. Tympanocentesis was performed at baseline and clinical responses were assessed at days 12-14 (end of therapy) and at days 25-28 (end of study). RESULTS: The study enrolled 313 patients, and 83% of the patients were < or =2 years of age. A total of 158 patients in the azithromycin group and 154 in the amoxicillin group were considered clinical modified intent-to-treat patients. A middle ear pathogen was detected for 212 patients (68%). Haemophilus influenzae was the most common pathogen (isolated for 96 patients), followed by S. pneumoniae (92 patients), Moraxella catarrhalis (23 patients) and Streptococcus pyogenes (23 patients). beta-Lactamase production was observed for 17% of H. influenzae isolates and 100% of M. catarrhalis isolates. Thirty-five (38%) S. pneumoniae isolates were penicillin-nonsusceptible and 24 (26%) isolates were macrolide-resistant. At the end of therapy, clinical success rates for azithromycin and amoxicillin were comparable for all patients (84 and 84%, respectively) and for children < or =2 years of age (82 and 82%, respectively). At the end of therapy and end of study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithromycin (80%) and patients treated with amoxicillin (83%). The rates of treatment-related adverse events for azithromycin and amoxicillin were 20% and 29%, respectively (P = 0.064). Diarrhea was more common in the amoxicillin group than in the azithromycin group (17.5 and 8.2%, respectively) (P = 0.017). Compliance, defined as completion of > or =80% of the study medication, was higher in the azithromycin group (100%) than in the amoxicillin group (90%) (P = 0.001). CONCLUSIONS: In this study, single dose azithromycin was as effective as high dose amoxicillin for the treatment of children with AOM, whereas rates of adverse events were lower and compliance improved with the simplified single dose regimen.

Efficacy and safety of a novel, single-dose azithromycin microsphere formulation versus 10 days of levofloxacin for the treatment of acute bacterial sinusitis in adults.

OBJECTIVE: To compare the efficacy and safety of a single 2.0-g dose of a novel azithromycin microsphere formulation with that of 10 days of levofloxacin, 500 mg/d, when used to treat adults with uncomplicated acute bacterial maxillary sinusitis (ABS). STUDY DESIGN AND SETTING: An international, multicenter, randomized, double-blind, double-dummy trial. Eligible outpatients > or =18 years of age with clinical and radiographic evidence of ABS underwent maxillary sinus aspiration before randomization. Primary endpoint was clinical efficacy at the test-of-cure visit (day 17-24). RESULTS: Clinical success rates were 94.5% (242/256) in azithromycin-microspheres-treated patients and 92.8% (233/251) in the levofloxacin group. In patients with documented Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were 97.3% (36/37), 96.3% (26/27), and 100% (8/8), respectively, for the azithromycin group and 92.3% (36/39), 100% (30/30), and 90.9% (10/11), respectively, for the levofloxacin group. CONCLUSIONS: Single-dose azithromycin microspheres provided clinical and bacteriologic efficacy and safety comparable to 10 days of levofloxacin. SIGNIFICANCE: A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS.

Efficacy of single-dose azithromycin in treatment of acute otitis media in children after a baseline tympanocentesis.

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.

Bacteriología del adenoides en otitis media secretora / Bacteriology of the adenoid in secretory otitis media

Se realizó un estudio en 90 niños del Hospital San Juan de Dios en el período comprendido entre mayo de 1989 y junio de 1990, los que se dividieron en cuatro grupos: Grupo I, de 24 niños con otitis media secretora (OMS) e hiperplasia adenoidea obstructiva (HAO); grupo II, de 28 niños con HAO sin OMS; grupo III, de 24 niños con OMS sin HAO y grupo IV, de 14 niños sin patología otorrinolaringológica. Se cultivó 1 gramo del adenoides de estos niños, en condiciones óptimas de asepsia para estudio de gérmenes aerobios y anaerobios y su sensibilidad a antibióticos. Los resultados se tabularon y sometieron a estudio estadístico mediante pruebas de chi cuadrado y z

Carcinoma mucoepidermoide salival: gradación histológica / Salivary glands mucoepidermoid carcinoma: hitological classification

Se revisó las características histológicas y clínicas de 25 casos de CME de las glándulas salivales mayores y menores. Hubo 13 casos en las mayores (11 parotídeos) y 12 en las menores (4 palatinos). Se clasificó a los tumores en CME de malignidad baja (MB) (14 casos), malignidad intermedia (MI) (5 casos) y malignidad alta (MA) (6 casos). Los de MB fueon predominantemente quísticos, con mayor proporción de células mucinosas, con leve atipia, mínima actividad mitótica, escasa capacidad invasora, tamaño promedio 2.1 cm. y márgenes quirúrgicos libres. En éste grupo no hubo recidivas ni metástasis regionales o a distancia. Los de MI fueron mayoritariamente sólidos, con alta proporción de células intermedias y epidermoides, con células mucinosas en cantidad apreciable, con moderada atipia, con actividad mitótica algo mayor; en el resto de las características no hubo diferencias con el grado de MB. Los de MA fueron sólidos, con franco predominio de células epidermoides, con marcada atipia, con abundantes mitosis; con invasión agresiva local y general, con tamaño promedio de 5.25 cm. Todos los pacientes fallecieron antes del año por la enfermedad local o general. El grado histológico y el tamaño del tumor fueron los parámetros que mejor se correlacionaron con la evolución y el pronóstico de nuestros pacientes