Treatment of gonococcal infections with a single 250 mg intramuscular injection of trospectomycin sulphate vs ceftriaxone sodium.

Trospectomycin sulphate is a new, more potent analog of spectinomycin, which is active in vitro against penicillin-sensitive and penicillin-resistant strains of Neisseria gonorrhoeae. This study was designed to determine the bacteriologic and clinical efficacy as well as safety of a single intramuscularly administered 250 mg dose of trospectomycin sulphate in the treatment of uncomplicated gonorrhoea (cervical, urethral, pharyngeal and anal). Ceftriaxone sodium was used as a comparator antibiotic in a single 250 mg intramuscular dose. Seventy-four patients (36 women and 38 men) were evaluable in the trospectomycin treated group and 40 patients (22 women and 18 men) in the ceftriaxone treated group. The overall bacteriologic cure rate was 98.6% (73/74) for trospectomycin and 95% (38/40) for ceftriaxone. Bacteriologic failures were observed among women 1/36 (2.8%) treated with trospectomycin and 2/22 (9.1%) treated with ceftriaxone. The overall clinical success rate (clinically cured plus clinically improved) was 90.5% for trospectomycin and 100% for ceftriaxone. Adverse events were reported rarely in both groups. Less than 10% of patients complained of pain and/or tenderness at the injection site for both drugs; one patient developed a generalized, pruritic rash which occurred three days after administration of trospectomycin and resolved within six days. In conclusion, a single dose of 250 mg i.m. trospectomycin appears to be at least as effective and safe as a single dose of ceftriaxone in the treatment of uncomplicated gonorrhoea.