Trep-AB
Trial question
Is oral linezolid noninferior to benzathine penicillin G in patients with early syphilis?
Study design
Multi-center
Open label
RCT
Population
59 male patients.
Inclusion criteria: adult patients with serological or molecular confirmation of syphilis.
Key exclusion criteria: known allergy to investigational drugs; symptomatic neurosyphilis; concurrent use of drugs with potential interactions; previous treatment for early syphilis within the past 6 months; antibiotic treatment potentially active against Treponema pallidum in the past week; pregnancy; concomitant symptomatic STI.
Interventions
N=29 linezolid (at an oral dose of 600 mg/day for 5 days).
N=30 benzathine penicillin G (single dose of 2.4 million IU IM).
Primary outcome
Rate of treatment response after 48 weeks of follow-up
70%
100%
100.0 %
75.0 %
50.0 %
25.0 %
0.0 %
Linezolid
Benzathine penicillin
G
Difference exceeding
non-inferiority
margin ✗
Difference exceeding non-inferiority margin in the rate of treatment response after 48 weeks of follow-up (70% vs. 100%; ARD -29.6, 95% CI -50.5 to -8.8).
Safety outcomes
No significant difference in drug-related adverse events.
Conclusion
In adult patients with serological or molecular confirmation of syphilis, linezolid was not noninferior to benzathine penicillin G with respect to the rate of treatment response after 48 weeks of follow-up.
Reference
Maria Ubals, Patricia Nadal-Baron, Maider Arando et al. Oral linezolid compared with benzathine penicillin G for treatment of early syphilis in adults (Trep-AB Study) in Spain: a prospective, open-label, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2024 Apr;24(4):404-416.
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