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Antibiotic

Benzathine Penicillin for Syphilis

Phase 4
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through month 12
Awards & highlights

Study Summary

This trial is testing whether one big dose of penicillin or three smaller doses given over three weeks is better at treating early syphilis in people with or without HIV. 560 people will be enrolled and the trial will last for 48 months.

Eligible Conditions
  • Syphilis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and through month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Number of Participants With a Serological Response by Month 6.
Secondary outcome measures
Categorical Descriptive Statistics of Participant Baseline Demographics Collected Via a Study-specific Questionnaire
Categorical Descriptive Statistics of Sexual History at Baseline Collected Via a Study-specific Questionnaire
Categorical Descriptive Statistics of Socio-epidemiologic Characteristics at Baseline Collected Via a Study-specific Questionnaire
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental Treatment1 Intervention
2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly weekly for three successive weeks, n=280
Group II: 1Active Control1 Intervention
2.4 million units (MU) of Benzathine penicillin G (BPG) intramuscularly on Day 1, n=280
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benzathine Penicillin
2000
Completed Phase 3
~600

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,140 Total Patients Enrolled
8 Trials studying Syphilis
10,012 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.

Have any further experiments been conducted on Benzathine Penicillin?

"Benzathine Penicillin was initially explored in 2018 by the University of Alabama at Birmingham School of Medicine - Infectious disease. Presently, there are 23 completed trials and 8 active ones with a number of these being hosted in Seattle, Washington."

Answered by AI

Is this study actively seeking participants at the moment?

"Yes, according to data published on clinicaltrials.gov this study has been open for recruitment since September 12th 2018 and is still actively seeking 560 participants across 10 sites as of November 23rd 2022."

Answered by AI

What conditions is Benzathine Penicillin usually prescribed to treat?

"Benzathine Penicillin has been indicated as a useful treatment for empyema, listeriosis, and other communicable ailments."

Answered by AI

Who meets the criteria necessary to qualify for this medical experiment?

"Eligibility to take part in this study necessitates that the patient suffers from syphilis and is within the age bracket of 18-99. The clinical trial seeks 560 participants in total."

Answered by AI

Is there a network of healthcare facilities investigating the effects of this study in North America?

"Currently, this medical trial is offered at 10 different sites in the United States. A few of these locations are Seattle, Pittsburgh and New Orleans while others may be easily found using an internet search engine. To reduce travel requirements for potential participants it can be advantageous to select a clinic that is near you."

Answered by AI

Does Benzathine Penicillin confer any risks to patients?

"Benzathine Penicillin has an efficacy score of 3 due to its Phase 4 trial status, which denotes approval by governing bodies."

Answered by AI

How many participants are being taken into consideration for this clinical trial?

"This medical trial must recruit 560 participants that satisfy the set inclusion criteria. Two sites, University of Washington - Harborview Medical Center - Center for AIDS and STD in Seattle, WA and Magee Women's Hospital of UPMC - Reproductive Infectious disease Research in Pittsburgh, PA are actively recruiting patients to join this study."

Answered by AI

Is the eligibility criterion for this research limited to participants aged 20 or older?

"For this clinical trial to be successful, it requires the recruitment of individuals aged 18 - 99."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Emory University Hospital Midtown - Emory Clinic Infectious Diseases
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
Sexually Transmitted DiseasesJournal
Coinfection with Chlamydial and Gonorrheal Infection Among US Adults with Early Syphilis
Dionne-Odom, Jodie, Kimberly Workowski, Charlotte Perlowski, Stephanie N. Taylor, Kenneth H. Mayer, Candice J. McNeil, Matthew M. Hamill, et al.. 2022. “Coinfection with Chlamydial and Gonorrheal Infection Among US Adults with Early Syphilis”. Sexually Transmitted Diseases. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/olq.0000000000001605.
clinicaltrials.govStudy
Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
2018. "Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03637660.
~85 spots leftby Apr 2025
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