Effect on the Resistome of Dual vs Monotherapy for the Treatment of Neisseria gonorrhoeae: Results From a Randomized Controlled Trial (ResistAZM Trial)

Author:

Thibaut Vanbaelen1ORCID,Eric Florence12ORCID,Christophe Van Dijck1ORCID,Achilleas Tsoumanis1ORCID,Laumen Jolein Gyonne Elise1ORCID,Sheeba Manoharan-Basil Santhini1ORCID,Saïd Abdellati1ORCID,De Block Tessa1,Irith De Baetselier1ORCID,Dorien Van den Bossche1ORCID,Yven Van Herrewege1ORCID,Anke Rotsaert3ORCID,Chris Kenyon1ORCID

Affiliation:

1. Department of Clinical Sciences, Institute of Tropical Medicine , Antwerp , Belgium

2. Department of General Internal Medicine, Infectious Diseases and Tropical Medicine, University Hospital of Antwerp , Antwerp , Belgium

3. Department of Public Health, Institute of Tropical Medicine , Antwerp , Belgium

Abstract

Abstract Background No randomized controlled trial (RCT) has compared the impact on the resistome of ceftriaxone (CRO) plus azithromycin (AZM) vs CRO for the treatment of Neisseria gonorrhoea (NG). Methods This was an open-label, single-center, RCT comparing the effect on the resistome of CRO plus AZM vs CRO for the treatment of NG. Men who have sex with men (MSM) with genital, anorectal, or pharyngeal NG infection were randomized into the CRO/AZM and CRO arms. Oral rinse and anorectal samples were taken for culture and resistome profiling at 2 visits (baseline and day 14). The primary outcome was the ratio of mean macrolide resistance determinants in anorectal samples from day 14 between arms. Results Twenty individuals were randomized into the CRO/AZM arm and 22 into the CRO arm. We found no significant difference in the mean macrolide resistance determinants in the day 14 anorectal samples between arms (ratio, 1.05; 95% CI, 0.55–1.83; P = .102). The prevalence of baseline macrolide resistance was high (CRO/AZM arm = 95.00%; CRO arm = 90.91%). Conclusions We could not demonstrate a significant effect of dual CRO/AZM therapy on the resistome compared with CRO alone, likely due to a high baseline resistance to AZM. Interventions to prevent the emergence of antimicrobial resistance in MSM are needed.

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Oncology

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