Multicenter clinical trial of the efficacy and safety of rokitamycin in ENT infections

This trial was designed to confirm the efficacy and safety of rokitamycin in acute ENT infections in adults. A total of 66 adults were recruited in four specialized centers (35 male, 31 female), mean age 37.6 ± 14.8 years (range 18-81), mean weight 67.3 ± 9.9 kg (range 49-85), with acute ENT infections. Patients were given 400 mg of rokitamycin orally twice a day (800 mg/day), for seven days. During treatment the symptoms of infection rapidly improved, and after only three days there were reductions of 66.7% in ear pain, 50% in the 'closed ear feeling', 57.1% in pain, 50% in headache, 44.4% in secretion and 48.3% in pharyngodynia. By the end of treatment most patients no longer had symptoms and the microorganisms isolated at the start were no longer detectable in 95.4% of cases (Gram-negative: 2 Proteus mirabilis, 1 Pseudomonas aeruginosa; Gram-positive: 8 Staphylococcus aureus, 7 Staphylococcus epidermidis, 1 Staphylococcus spp., 16 Streptococcus alpha-haemolyticus, 4 Streptococcus beta-haemolyticus, 21 Streptococcus spp., 5 Streptococcus viridans). There was one reinfection with Strept. pyogenes. Treatment was well tolerated in 98.5% of cases, only one patient presenting slight skin rash. The findings of this trial therefore confirm that rokitamycin is an effective and well tolerated antibacterial treatment for acute ENT infections.