What side effects are associated with this type of intervention?

The most common treatments for syphilis include penicillin, doxycycline, tetracycline, and azithromycin. Penicillin can cause allergic reactions, ranging from mild rashes to severe anaphylaxis. Doxycycline and tetracycline, which inhibit bacterial protein synthesis, can cause gastrointestinal upset, photosensitivity, and, rarely, esophageal irritation or ulceration. Azithromycin may lead to gastrointestinal disturbances, potential liver enzyme elevation, and, in rare cases, cardiac arrhythmias. Linezolid, another protein synthesis inhibitor, can cause side effects such as myelosuppression, peripheral neuropathy, and lactic acidosis.

What prior FDA approvals exist?

The primary FDA-approved treatments for syphilis are penicillin-based antibiotics, such as benzathine penicillin G, which work by inhibiting bacterial cell wall synthesis. While Linezolid, which inhibits bacterial protein synthesis, is being studied for syphilis, it is not yet an FDA-approved treatment for this condition. Other antibiotics like doxycycline and azithromycin, which also inhibit protein synthesis, have been used off-label for patients allergic to penicillin, but they are not the first-line treatments.

What other types of research exist?

Promising novel alternatives to Linezolid for the treatment of syphilis include newer tetracyclines like sarecycline, which has a targeted spectrum and has shown efficacy in treating bacterial infections. Additionally, azithromycin, a macrolide antibiotic, has been studied for its effectiveness in treating various bacterial infections and could be considered as an alternative.

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Oxazolidinone Antibiotic

Linezolid vs Penicillin for Syphilis

Phase 2

Recruiting

Led By Jeffrey D Klausner, MD MPH

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial is testing linezolid, an antibiotic taken by mouth, to treat syphilis. It includes people with and without HIV. Linezolid works by stopping bacteria from growing. The study aims to find an alternative to penicillin, especially for those who can't use it due to allergies or shortages.

Who is the study for?

This trial is for individuals aged 16 or older diagnosed with primary, secondary, or early latent syphilis and have a recent RPR titer of at least 1:8. People living with HIV can join if they're on treatment and meet certain viral load or CD4 count criteria. Pregnant individuals, those on specific antibiotics or psychotropic meds, and anyone allergic to the study drugs cannot participate.

What is being tested?

The study compares the effectiveness of two treatments for syphilis: Group A receives Penicillin (the standard treatment), while Group B gets Linezolid for 10 days. The goal is to see if Linezolid is an effective alternative.

What are the potential side effects?

Linezolid may cause headaches, nausea, diarrhea, vomiting; it might also affect blood counts leading to anemia or decrease in white cells increasing infection risk. Penicillin side effects include allergic reactions ranging from rashes to more severe responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response to Treatment

Secondary study objectives

Globus Pallidus

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Linezolid 10 DayExperimental Treatment1 Intervention

Oral linezolid 600mg, taken twice a day for 10 days

Group II: Benzathine Penicillin GActive Control1 Intervention

Single intramuscular injection of 2.4 million units of benzathine penicillin G

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Syphilis is Penicillin, which works by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. Linezolid, a treatment under study, inhibits bacterial protein synthesis by binding to the bacterial ribosome and preventing the formation of a functional 70S initiation complex. These mechanisms are important for Syphilis patients as they ensure the effective elimination of the bacteria, reducing symptoms and preventing further complications.

Therapy for nonvenereal treponematoses: review of the efficacy of penicillin and consideration of alternatives.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

936 Previous Clinical Trials

1,613,457 Total Patients Enrolled

1 Trials studying Syphilis

400 Patients Enrolled for Syphilis

Universidad Peruana Cayetano HerediaOTHER

78 Previous Clinical Trials

62,204 Total Patients Enrolled

1 Trials studying Syphilis

400 Patients Enrolled for Syphilis

The University of Texas Health Science Center, HoustonOTHER

934 Previous Clinical Trials

333,784 Total Patients Enrolled

1 Trials studying Syphilis

924 Patients Enrolled for Syphilis

~7 spots leftby Mar 2025

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