Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05548426
Other study ID # APP-22-04165
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 28, 2023
Est. completion date March 2025

Study information

Verified date December 2023
Source University of Southern California
Contact Jeffrey D Klausner, MD MPH
Phone (415) 876-8901
Email jdklausner@med.usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to evaluate the efficacy of linezolid for the treatment of syphilis.


Description:

This will be a randomized, open-label, non-comparative, adaptive pilot trial to evaluate the efficacy of linezolid 600mg orally, twice a day, for five or ten days, using a contemporaneous historical control group benzathine penicillin G (single dose of 2.4 million units) in participants with and without HIV infection. In total, 24 participants will be enrolled across multiple clinical sites in the United States. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) at 1 month, 3 months, and 6 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin that is effective for people living with HIV. Study findings may also help address the crisis of penicillin shortages, difficulty in administration, and offer options for those with penicillin allergy.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - 16 years of age or older - Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer =1:8 within 3 weeks prior to enrollment - Able to provide informed consent - For PLHIV: on treatment for HIV-infection and most recent viral load <200 copies/mL or most recent CD4 T-cell count >350 cells/mL Exclusion Criteria: - Pregnancy or a positive pregnancy test on the day of enrollment - Participants who receive certain psychotropic medications, e.g., MAO inhibitors, SNRIs, SSRIs - Patients showing signs and symptoms of neurosyphilis - Serofast RPR titer - Recent (<7 days) or concomitant antimicrobial therapy with azithromycin, doxycycline, ceftriaxone, cefixime, or other beta lactam antibiotics (e.g. amoxicillin) - Linezolid or penicillin allergy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Group B, Linezolid 10d
Oral Linezolid 600mg, taken twice a day for 10 days
Group A, Penicillin
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU

Locations

Country Name City State
United States Howard Brown Health Chicago Illinois
United States Open Arms HealthCare Center Jackson Mississippi

Sponsors (3)

Lead Sponsor Collaborator
University of Southern California The University of Texas Health Science Center, Houston, Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response to Treatment Percentage of linezolid participants with a 4-fold decrease or greater in the serum RPR titer by 180 days after treatment 6 months
See also
  Status Clinical Trial Phase
Completed NCT03660488 - Cefixime for Alternative Syphilis Treatment Phase 2
Completed NCT02191527 - Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique N/A
Completed NCT01439503 - Safer Sex Program for Young African-American Men Phase 2
Completed NCT02257658 - Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM N/A
Terminated NCT01540227 - Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.
Completed NCT02611765 - Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study Phase 4
Not yet recruiting NCT06428643 - A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities N/A
Completed NCT03709862 - Global Syphilis Sequencing
Completed NCT03637660 - Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection Phase 4
Active, not recruiting NCT03310424 - Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum
Completed NCT00207506 - Lay Health Advisors for Sexually Transmitted Disease Prevention Phase 1/Phase 2
Completed NCT00213018 - Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission Phase 2
Recruiting NCT06059443 - mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention N/A
Completed NCT04480749 - Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST) Phase 4
Not yet recruiting NCT06058286 - MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in Indonesia N/A
Active, not recruiting NCT03980223 - Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men Phase 4
Completed NCT01465607 - Implementation of an Efficacious Intervention for High Risk Women in Mexico N/A
Completed NCT00553111 - Video Tool to Promote Knowledge of Syphilis as Facilitator of HIV Transmission N/A
Active, not recruiting NCT06367621 - Retrospective Study of iStatis Syphilis Ab Test (POC)
Completed NCT02445846 - Dual Rapid HIV & Syphilis Tests in Zambia N/A