amoxicillin-potassium-clavulanate-combination and brodimoprim

Brodimoprim is a long acting broad spectrum antibacterial agent. It is a new selective inhibitor of bacterial dihydrofolate reductase, structurally related to trimethoprim. The aim of the present study was to investigate the efficacy and tolerability of brodimoprim (10 mg/kg on the first day, 5 mg/kg/die onward) in the treatment of upper respiratory tract infections in children (age range: 2-14 years). This open group comparative study was performed either in 68 children affected by bacterial pharyngotonsillitis (37 treated with brodimoprim, 31 with erythromycin 560 mg/kg/8 hours) or in 50 patients affected by otitis media (25 treated with brodimoprim, 25 with amoxicillin/clavulanic acid 50 mg/kg/12 hours) or in 52 patients affected by acute sinusitis (25 treated with brodimoprim, 27 with amoxicillin/clavulanic acid 50 mg/kg/12 hours). All patients were clinically evaluated before admission, during the trial and 48 hours after the last dose of antibiotic. At the same time blood and secretion samples were collected for hematology/biochemistry and microbiological assays. A total of 170 subjects were treated and 141 patients demonstrated a clinical recovery/improvement following the treatment period, with approximately the same recovery rate (83%) among the groups. The bacteriological response was evaluated in 169 subjects. Eradication of pathogens was documented in 27 subjects treated with brodimoprim and 28 with erythromycin in the pharyngotonsillitis group, in 22 subjects treated with brodimoprim and 16 with amoxicillin/clavulanic acid in the otitis group and in 17 subjects treated with brodimoprim and 20 with amoxicillin/clavulanic acid in the sinusitis group. The overall eradication in brodimoprim treated patients was 77% in comparison with 76% of eradication obtained in the control groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Erythromycin; Humans; Otitis Media; Pharyngitis; Respiratory Tract Infections; Sinusitis; Tonsillitis; Trimethoprim

160 children with an average age of 9 years (range 6-15) affected by acute bacterial tonsillitis, were selected and assigned, following an open, parallel group design to: a) brodimoprim at the dose of 10 mg/kg on the first day, in single administration, and of 5 mg/kg on the following days; b) cotrimoxazole suspension, at the dosage of 6 mg of trimethoprim/kg/day, in two daily administrations; c) amoxicillin with clavulanic acid suspension (amoxi-clavulanate) 50 mg/kg every 12 hours. Quantity of pharynx and tonsillar exudate, pharynx pain, dysphonia and dysphagia were checked at the basal time, 3rd, 7th and at the last day of therapy. These symptoms were evaluated using a four-step rating scale. The evolution of body temperature was measured at two different times (1 and 5 o'clock p.m.), until the end of treatment, foreseen five days after disappearance of fever. Microbiological evaluation through a pharynx swab was performed at the beginning and at the end of therapy. Side-effects were registered during all the observation period. Lab-tests were carried out at the enrollment and at the end of treatment. The frequency and intensity of symptoms decreased significantly in all treatment groups. In comparison with amoxi-clavulanate, the brodimoprim group showed an earlier improvement (3rd day) of the clinical situation and a significantly better regression of pharynx exudate (p < 0.01), pharynx pain (p < 0.05) and dysphonia (p < 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Humans; Pharyngitis; Suspensions; Tonsillitis; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination