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

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 A...

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Published in:Open forum infectious diseases 2023-10, Vol.10 (10), p.ofad462-ofad462
Main Authors: Vanbaelen, Thibaut, Florence, Eric, Van Dijck, Christophe, Tsoumanis, Achilleas, Laumen, Jolein Gyonne Elise, Santhini Manoharan-Basil, Sheena, Abdellati, Saïd, De Block, Tessa, De Baetselier, Irith, Van den Bossche, Dorien, Van Herrewege, Yven, Rotsaert, Anke, Kenyon, Chris
Format: Article
Language:English
Subjects:
Care and treatment
Clinical trials
Comparative analysis
Drug resistance in microorganisms
Health aspects
Infection
Major
Methylene blue
Oral medication
Sexually transmitted diseases
Tetracycline
Tetracyclines
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Summary: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.
ISSN:2328-8957
2328-8957
DOI:10.1093/ofid/ofad462