Clinical Infectious Diseases 2021

Effective treatment of Lymphogranuloma venereum proctitis with Azithromycin.

Blanco JL, Fuertes I, Bosch J, De Lazzari E, González-Cordón A, Vergara A, Blanco-Arevalo A, Mayans J, Inciarte A, Estrach T, Martínez E, Cranston RD, Gatell JM, Alsina-Gibert M
Lymphogranuloma venereum (LGV) is a sexually transmitted infection caused by Chlamydia trachomatis (CT) serovars L1, L2, and L3 and is endemic among men who have sex with men (MSM) in Europe. We evaluated weekly oral Azithromycin 1 g for 3 weeks as a treatment for LGV proctitis. This is an open clinical trial with convenience allocation according to treating physician preferences. Adults with clinical proctitis received a single dose of 1 g of intramuscular ceftriaxone and were subsequently allocated to receive (i) Doxycycline 100 mg twice daily for 21 days (Doxycycline-group) or, (ii) Azithromycin 1 g orally once weekly for 3 weeks (Azithromycin-group). LGV-cure, (primary endpoint) was defined as resolution of symptoms at week 6 (clinical cure, LGV-CC), with an additional supporting negative rectal PCR at week 4 (microbiological cure; LGV-MC), if available. One hundred and twenty-five individuals with LGV clinical proctitis were included. All were MSM and 96% were HIV-positive. Eighty-two were in the Azithromycin-group and 43 in the Doxycycline-group. LGV-cure on a modified intention-to-treat analysis (primary endpoint), occurred in 80 of 82 (98%) in the Azithromycin-group versus 41 of 43 (95%) in Doxycycline-group [treatment difference (95% CI) 2.2% (-3.2; 13.2)]. LGV-MC occurred in 70 of 72 (97%) vs 15 of 15 (100%) in Azithromycin-group and Doxycycline-group, respectively [treatment difference (95% CI) -2.8% (-9.6; 17.7)]. Adverse events were similar in both treatment groups. Our findings support extended azithromycin dosing as an alternative treatment option for symptomatic LGV proctitis and provides the rationale for future randomized trials. © The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: