Efficacy and tolerability of brodimoprim in pharyngotonsillitis in children
Galetti, G.; Dallari, S.
Journal of ChemoTherapy 5(6): 548-550
1993
ISSN/ISBN: 1120-009X PMID: 8195855 Document Number: 414856
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, 3-rd, 7-th 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 clays 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 lt 0.01), pharynx pain (p lt 0.05) and dysphonia (p lt 0.01). In the comparison between brodimoprim and cotrimoxazole, besides the significant decrease of the clinical symptoms in both groups (p lt 0.001), the reduction of the quantity of exudate at the end of treatment was more evident and significant in the brodimoprim group (p lt 0.05). Both drugs were active against most of the examined pathogenic strains; with brodimoprim greater negativizations of the bacteriologic tests (92.5%) were achieved than with cotrimoxazole (82.5%). Haemophilus influenzae was more sensitive to brodimoprim while against Streptococcus pyogenes amoxi-clavulanate was preferable but no statistical difference was found. Side-effects were reported by 9 patients in the brodimoprim group (2 dropped out) and by 11 subjects in the other two groups (6 dropped out). Brodimoprim suspension's taste - in comparison with amoxi-clavulanate - and the dose regimen was preferred by the children involved in the trial. No serious variation in lab-tests occurred.