LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Apr 27, 2024
Trial Information
Current as of November 14, 2025
Recruiting
Keywords
ClinConnect Summary
The LIMIT Trial is studying whether adding lidocaine, a local anesthetic that numbs the area, can help reduce pain from injections of benzathine penicillin G (BPG), which is used to treat syphilis. Past studies have shown that lidocaine can lessen the discomfort of these injections, but this trial aims to confirm those findings in a more controlled way. Participants will receive two injections of BPG: one will have lidocaine added to it, while the other will not, and neither the participants nor the healthcare providers will know which injection contains lidocaine and which has a saltwater solution instead.
To be eligible for this trial, participants must be adults aged 18 or older with a confirmed syphilis diagnosis and be receiving their first injection in a series. Those with allergies to penicillin or lidocaine, or who are pregnant, cannot participate. After the injections, participants will report their pain levels at two different times, helping researchers understand if lidocaine truly makes a difference in reducing pain during BPG injections. This study is an important step in improving the treatment experience for patients receiving these necessary injections.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults 18 years of age or above
- • Confirmed syphilis diagnosis (reactive RPR with confirmatory treponemal testing)
- • Receiving first injection in series if patient requires 3x weekly injections for syphilis treatment
- Exclusion Criteria:
- • Penicillin allergy (anaphylaxis)
- • Lidocaine allergy (anaphylaxis)
- • Second or third injection in series if patient requires 3x weekly injections for syphilis treatment
- • Pregnancy
About Washington University School Of Medicine
Washington University School of Medicine is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research, education, and patient care. With a strong emphasis on translating scientific discoveries into practical applications, the institution conducts a diverse array of clinical trials aimed at improving treatment outcomes and enhancing the understanding of various medical conditions. Its collaborative environment fosters partnerships between researchers, clinicians, and community stakeholders, ensuring that the trials not only contribute to scientific knowledge but also address the pressing health needs of diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saint Louis, Missouri, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported