Cefixime versus benzathine penicillin G for the treatment of early syphilis-a randomized, controlled open label trial.

Objectives: Cefixime is a promising oral treatment alternative for early syphilis but only very limited efficacy data exist. We evaluated the efficacy and safety of cefixime for the treatment of early syphilis.

Methods: A randomized controlled, open label trial in patients with confirmed early syphilis who were randomized to treatment with cefixime 400 mg orally twice a day for 14 consecutive days or to a single dose of benzathine penicillin G (BPG) 2.4 MIU intramuscular. The outcome was a 4-fold or more (≥2 dilution steps) decrease in Venereal Disease Research Laboratory test (VDRL) titre from baseline to 3 months (primary outcome) or 12 months (secondary outcome) after the treatment.

Results: Of 61 randomized patients, 58 (95.1%) completed the study (28 patients in the cefixime arm and 30 in the BPG arm). In the intention to treat analysis, the primary endpoint was achieved after 3 months in 22 of 30 (73.3%) of patients in the cefixime arm and 27 of 31 (87.1%) in the BPG arm, and after 12 months in 28 of 30 (93.3%) of patients in the cefixime arm and 30 of 31 (96.8%) of patients in the BPG arm. Both treatments were well tolerated and no serious adverse events or adverse events with severe intensity were reported.

Conclusions: The results from our study are consistent with current limited knowledge and suggest that oral cefixime can be an effective and safe therapy for the treatment of early syphilis. However, additional efficacy data from larger treatment studies are imperative.