An open evaluation of the efficacy and safety of the new macrolide roxithromycin in the treatment of lower respiratory tract infections and pneumonia in Nigerian patients.

Roxithromycin, a new introduction into the macrolide class of antibiotics possesses favourable pharmacokinetic properties enabling a once daily dosing. This study evaluates its efficacy, safety and tolerability, previously demonstrated in Europe and North America, in Nigeria patients suffering from lower respiratory tract infections. 32 patients, aged 18-65 years with acute bronchitis/acute exacerbation of chronic bronchitis and pneumonia were administered roxithromycin 300 mg once daily. 25 patients (12 males, 13 females: aged 39.2 +/- 2.7 years) were evaluable for clinical efficacy at the end of the study. The mean duration of treatment was 6.9 +/- 0.5 days. 22 patients (88.0%) responded to therapy. Sputum culture was positive in 5 patients (20.0%): Streptococcus pneumonia and resistant Klebsiella pneumonia. Therapy was discontinued in 3 patients due to non-response. The two patients in whom Klebsiella were isolated did not show any significant clinical improvement. The third non responding patient developed empyema. Gram negative bacilli were identified in the pleural aspirate but no patients with resistant Streptococcus pneumonia improved clinically. Adverse effects were mild, transient and included nausea (4) and diarrhoea (1). The study suggests that roxithromycin is an effective and well tolerated antibacterial in the treatment of lower respiratory tract infection.