New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea

Summary

This study evaluates the efficacy of three experimental antibiotics in the treatment of uncomplicated anogenital gonorrhoea. Participants will be randomized to one of four study arms and will receive either one of the three experimental antibiotics (ertapenem, fosfomycin and gentamicin) or the current standard antibiotic (ceftriaxone). Both the study team and the participant are blinded to the administered treatment. This enables the investigators to compare the eradication capacity and safety of the experimental antibiotics with the standard treatment. \*Following the advise of the DSMB based on a planned interim analysis, in October 2018 one study arm (fosfomycin 6g PO) was dropped and the randomized clinical trial was continued with three treatment arms (ceftriaxone 500mg IM, ertapenem 1000mg IM and gentamicin 5mg/kg IM) and without the oral placebo.

Timeline

Start

2017-09-18

Primary completion

2020-06-05

Completion

2020-06-05

Publications

• Teker B, Schim van der Loeff M, Boyd A, Mathot R, van Dam A, de Vries H, Jongen VW. Diarrhoea as a frequent adverse event after intramuscular ertapenem treatment for uncomplicated Neisseria gonorrhoeae: a secondary analysis from the NABOGO trial. Sex Transm Infect. 2026 Jan 16:sextrans-2025-056735. doi: 10.1136/sextrans-2025-056735. Online ahead of print.
• Teker B, de Vries H, Heijman T, van Dam A, Schim van der Loeff M, Jongen VW. Spontaneous clearance of asymptomatic anogenital and pharyngeal Neisseria gonorrhoeae: a secondary analysis from the NABOGO trial. Sex Transm Infect. 2023 Jun;99(4):219-225. doi: 10.1136/sextrans-2022-055488. Epub 2022 Jul 12.
• de Vries HJC, de Laat M, Jongen VW, Heijman T, Wind CM, Boyd A, de Korne-Elenbaas J, van Dam AP, Schim van der Loeff MF; NABOGO steering group. Efficacy of ertapenem, gentamicin, fosfomycin, and ceftriaxone for the treatment of anogenital gonorrhoea (NABOGO): a randomised, non-inferiority trial. Lancet Infect Dis. 2022 May;22(5):706-717. doi: 10.1016/S1473-3099(21)00625-3. Epub 2022 Jan 19.

Drugs

Indications