← Back to Search

Penicillin Antibiotic

Cefixime vs. Penicillin for Syphilis

Phase 3
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
Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
Individuals with HIV infection must be on treatment for HIV infection and virologically suppressed (viral load <200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will compare the effectiveness of cefixime to benzathine penicillin G in treating syphilis.

Who is the study for?
This trial is for adults diagnosed with primary, secondary, or early latent syphilis who have an RPR titer of at least 1:8. People with HIV can join if they're on treatment and either have a low viral load or a CD4 count over 350. You can't join if you're pregnant, show signs of neurosyphilis, recently took certain antibiotics, are allergic to cephalosporins/penicillin, or can't make follow-up visits.Check my eligibility
What is being tested?
The study compares the effectiveness of two treatments for syphilis: Cefixime (400mg) versus benzathine penicillin G. It aims to determine which medication works better in curing the infection.See study design
What are the potential side effects?
Possible side effects may include allergic reactions like rashes or hives; gastrointestinal issues such as nausea or diarrhea; and less commonly, severe reactions like difficulty breathing due to anaphylaxis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with syphilis and my recent test shows a high level of infection.
Select...
I have HIV, am on treatment, and my viral load is under control or my CD4 count is above 350.
Select...
I am 18 years old or older.

Timeline

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CefiximeExperimental Treatment1 Intervention
Oral cefixime 400mg, 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

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,595,888 Total Patients Enrolled
1 Trials studying Syphilis
24 Patients Enrolled for Syphilis
AIDS Healthcare FoundationOTHER
18 Previous Clinical Trials
146,271 Total Patients Enrolled
1 Trials studying Syphilis
58 Patients Enrolled for Syphilis
Universidad Peruana Cayetano HerediaOTHER
76 Previous Clinical Trials
61,154 Total Patients Enrolled
1 Trials studying Syphilis
24 Patients Enrolled for Syphilis

Media Library

Benzathine Penicillin G (Penicillin Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04958122 — Phase 3
Syphilis Research Study Groups: Cefixime, Benzathine Penicillin G
Syphilis Clinical Trial 2023: Benzathine Penicillin G Highlights & Side Effects. Trial Name: NCT04958122 — Phase 3
Benzathine Penicillin G (Penicillin Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958122 — Phase 3

Frequently Asked Questions

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

How many patients are enrolled in this trial?

"That is correct, the clinical trial indicated on clinicaltrials.gov is still looking for potential participants. The study was first posted almost a year ago on June 20th, 2021 and was last edited on the same date this year. They are looking for 400 people to participate at 1 location."

Answered by AI

What is the most frequent diagnosis that Cefixime 400mg is given for?

"Cefixime 400mg is an effective antibiotic for treating salmonella infections, gonorrhea of the anus, and bacterial rhinosinusitis."

Answered by AI

Are we still receiving participants for this research project?

"The clinicaltrials.gov website reports that this trial is actively recruiting patients. The listing for the study was first posted on June 20th, 2021 and edited on June 20th, 2022."

Answered by AI

How does Cefixime 400mg compare to other medications in terms of safety for patients?

"Cefixime 400mg falls into Phase 3 of clinical trials, meaning that there is already some evidence backing its efficacy and multiple rounds of data supporting safety. Consequently, our team at Power rated Cefixime's safety as a 3."

Answered by AI

Are there other research papers that mention Cefixime 400mg?

"As of now, there are 12 ongoing clinical trials assessing Cefixime 400mg. 4 of these studies have reached Phase 3. Most of the research for Cefixime 400mg is conducted in Lalitpur, Bagmati; however, 103 different locations across the world are running similar trials."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Southern California
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Cefixime Clinical Trial
Jeffrey D Klausner 2021. "Cefixime Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04958122.
All > Aids
~22 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top