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Oral and Neuro-Penetrative Alternative Antibiotics for Patients with Syphilis

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514984-24-00
Acronym
Trep-AB
Enrollment
224
Registered
2024-09-23
Start date
2021-10-07
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syphilis

Brief summary

Measurement of clinical cure by the healing of primary syphilis lesions within 2 weeks and secondary syphilis lesions within 6 weeks (clinical cure) from treatment start., Assessment of serological cure by four-fold decline in RPR titer or seroreversion at 12, 24, and 48 weeks (serological cure) from treatment start., Assessment of recurrence by molecular methods of Treponema pallidum (T.p.) DNA to determine relapse or reinfection (molecular cure) within 48 weeks from treatment start.

Detailed description

Assessment of T.p. strains by genomic molecular methods in ulcer or mucosal lesion swabs from patients with primary or secondary syphilis, Assessment of T.p. strains by genomic molecular methods in plasma from patients with secondary or early latent syphilis., Assessment of T.p. strains by genomic molecular methods in oral swab/saliva from patients with secondary or early latent syphilis., Assessment of T.p. strains by genomic molecular methods in skin punch biopsy from patients with secondary syphilis (in a selected group of patients, Assessment of T.p. strains by genomic molecular methods in ear lobe scraping from patients with early latent syphilis (in a selected group of patients)., Assessment of T.p. strains by genomic molecular methods in CSF from patients with suspicion of neurosyphilis (in a selected group of patients, if lumbar puncture clinically indicated)., Comparative genomics between the “resistant” and sensitive T.p. strains to identify mutations that might be the resistance phenotype, Proportion of patients with adverse events (AEs) related to LZD treatment compared with standard BPG treatment in patients with early syphilis, Change of RPR titer at week 2 from treatment start.

Interventions

DRUGBENZATHINE BENZYLPENICILLIN
DRUGLINEZOLID

Sponsors

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Measurement of clinical cure by the healing of primary syphilis lesions within 2 weeks and secondary syphilis lesions within 6 weeks (clinical cure) from treatment start., Assessment of serological cure by four-fold decline in RPR titer or seroreversion at 12, 24, and 48 weeks (serological cure) from treatment start., Assessment of recurrence by molecular methods of Treponema pallidum (T.p.) DNA to determine relapse or reinfection (molecular cure) within 48 weeks from treatment start.

Secondary

MeasureTime frame
Assessment of T.p. strains by genomic molecular methods in ulcer or mucosal lesion swabs from patients with primary or secondary syphilis, Assessment of T.p. strains by genomic molecular methods in plasma from patients with secondary or early latent syphilis., Assessment of T.p. strains by genomic molecular methods in oral swab/saliva from patients with secondary or early latent syphilis., Assessment of T.p. strains by genomic molecular methods in skin punch biopsy from patients with secondary syphilis (in a selected group of patients, Assessment of T.p. strains by genomic molecular methods in ear lobe scraping from patients with early latent syphilis (in a selected group of patients)., Assessment of T.p. strains by genomic molecular methods in CSF from patients with suspicion of neurosyphilis (in a selected group of patients, if lumbar puncture clinically indicated)., Comparative genomics between the “resistant” and sensitive T.p. strains to identify mutations that might be the resist

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026