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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

Study Summary

This trial evaluates the effectiveness of linezolid compared to penicillin for syphilis & tests its susceptibility to novel & historical strains.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response to Treatment

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,152 Total Patients Enrolled

1 Trials studying Syphilis

400 Patients Enrolled for Syphilis

Universidad Peruana Cayetano HerediaOTHER

76 Previous Clinical Trials

61,530 Total Patients Enrolled

1 Trials studying Syphilis

400 Patients Enrolled for Syphilis

The University of Texas Health Science Center, HoustonOTHER

904 Previous Clinical Trials

320,936 Total Patients Enrolled

1 Trials studying Syphilis

924 Patients Enrolled for Syphilis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Linezolid 10 Day for medicinal use?

"Our team estimated that Linezolid 10 Day's safety rating is 2 due to the Phase 2 trial, which demonstrates some evidence of its safety but lacks data-based proof of efficacy."

Answered by AI

Are there vacancies available to those wishing to participate in this experiment?

"According to clinicaltrials.gov, this research study is currently in the recruitment phase. It was originally posted on September 28th 2023 and recently updated on October 23rd of that same year."

Answered by AI

How many volunteers have signed up for the trial thus far?

"Affirmative, the information provided on clinicaltrials.gov reveals that this investigation is still recruiting patients. The trial was first published on September 28th 2023 and updated lastly on October 23rd 2023 with 24 individuals being needed from 2 centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Linezolid for Syphilis Pilot Study

Jeffrey D Klausner 2023. "Linezolid for Syphilis Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05548426.