Trials Sponsors Conditions Drugs Pricing

Conditions

Syphilis Early Latent Syphilis Primary Syphilis Secondary Syphilis

Keywords

SyphilisBenzathine penicillin GRPRTreponema pallidumLinezolid

Outcome Measures

Primary Outcomes (1)

Proportion of participants achieving overall treatment success
Overall treatment success was defined as achievement of all outcome components applicable to the participant: clinical cure, serological cure, and absence of molecularly confirmed relapse.
at week 48

Secondary Outcomes (9)

Proportion of patients with clinical resolution of primary syphilis lesions (clinical cure, primary).
at week 2
Proportion of patients with clinical resolution of secondary syphilis lesions (clinical cure, secondary).
at week 6

Study Arms (2)

Post-interim - Linezolid 600 mg every 12 hours for 10 days

EXPERIMENTAL

After randomized to the experimental arm, the patient will take 1 tablet of Linezolid every 12hours during 10 days.

Drug: Linezolid 600 mg (post-interim)

Post-interim - Benzathine penicillin G 2.4 MUI single dose

ACTIVE COMPARATOR

After randomized to the control arm, the patient will receive a single dose of 2.4MUI intramuscular BPG.

Drug: Benzathine Penicilllin G (post-interim)

Interventions

Linezolid 600 mg (post-interim)Drug

Linezolid 600mg every 12hours during 10 days

Post-interim - Linezolid 600 mg every 12 hours for 10 days

Benzathine Penicilllin G (post-interim)Drug

Single dose of intramuscular BPG 2.4 MUI

Post-interim - Benzathine penicillin G 2.4 MUI single dose

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years or older at baseline visit.
Primary, secondary or early latent syphilis diagnosis based on SEIMC/IUSTI Guidelines\*

Sponsors & Collaborators

Study Sites (11)

CAP Drassanes-Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08001, Spain

Barcelona Checkpoint

Barcelona, Barcelona, 08015, Spain

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Hospital Germans Trias Pujol

Barcelona, Barcelona, 08916, Spain

Hospital 12 de Octubre

Madrid, Madrid, Spain

Leeds Sexual Health

Leeds, United Kingdom

Trafalgar Clinic and Waldron Centre Lewisham

Lewisham, United Kingdom

Related Publications (1)

Ubals M, Nadal-Baron P, Arando M, Rivero A, Mendoza A, Descalzo Jorro V, Ouchi D, Perez-Mana C, Alvarez M, Alemany A, Hoyos-Mallecot Y, Nunley E, Lieberman NAP, Greninger AL, Galvan-Casas C, Suner C, G-Beiras C, Paredes R, Rodriguez-Gascon A, Canut A, Garcia-Patos V, Farre M, Marks M, Giacani L, Vall-Mayans M, Mitja O. 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. doi: 10.1016/S1473-3099(23)00683-7. Epub 2024 Jan 8.
PMID: 38211601DERIVED

MeSH Terms

Conditions

Syphilis, LatentSyphilis, primarySyphilis, secondarySyphilisTreponemal Infections

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Spirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent InfectionSexually Transmitted Diseases, BacterialSexually Transmitted Diseases

Study Officials

Oriol Mitjà Villar, PhD
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
PRINCIPAL INVESTIGATOR

Enrollment

165 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Masking Details: The statistical analysis will be blinded.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 6, 2021

Study Start

Alternative Antibiotics for Syphilis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Post-interim - Linezolid 600 mg every 12 hours for 10 days

Post-interim - Benzathine penicillin G 2.4 MUI single dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Post-interim - Linezolid 600 mg every 12 hours for 10 days

Post-interim - Benzathine penicillin G 2.4 MUI single dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source records

Locations