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Cefixime Clinical Trial

Primary Purpose

Syphilis, Human Immunodeficiency Virus

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cefixime 400mg
benzathine penicillin
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syphilis focused on measuring Cefixime, Treponema pallidum, Penicillin, Early Syphilis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
  • 18 years of age or older
  • Able to provide informed consent
  • 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

Exclusion Criteria:

  • Pregnancy or a positive pregnancy test on the day of enrollment
  • Patients showing signs and symptoms of neurosyphilis
  • Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater
  • Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin)
  • Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test
  • Self-reported allergy to cephalosporins or penicillin
  • Unwilling or unable to attend follow-up visits

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cefixime

Benzathine Penicillin G

Arm Description

Oral cefixime 400mg, taken twice a day for 10 days

Single intramuscular injection of 2.4 million units of benzathine penicillin G

Outcomes

Primary Outcome Measures

Response to treatment
Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion

Secondary Outcome Measures

Full Information

First Posted
June 29, 2021
Last Updated
June 20, 2022
Sponsor
University of Southern California
Collaborators
AIDS Healthcare Foundation, Universidad Peruana Cayetano Heredia
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1. Study Identification

Unique Protocol Identification Number
NCT04958122
Brief Title
Cefixime Clinical Trial
Official Title
Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
AIDS Healthcare Foundation, Universidad Peruana Cayetano Heredia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.
Detailed Description
This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with HIV infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis, Human Immunodeficiency Virus
Keywords
Cefixime, Treponema pallidum, Penicillin, Early Syphilis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cefixime
Arm Type
Experimental
Arm Description
Oral cefixime 400mg, taken twice a day for 10 days
Arm Title
Benzathine Penicillin G
Arm Type
Active Comparator
Arm Description
Single intramuscular injection of 2.4 million units of benzathine penicillin G
Intervention Type
Drug
Intervention Name(s)
Cefixime 400mg
Intervention Description
Oral cefixime 400 mg, one capsule, twice a day for 10 days
Intervention Type
Drug
Intervention Name(s)
benzathine penicillin
Intervention Description
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU
Primary Outcome Measure Information:
Title
Response to treatment
Description
Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment 18 years of age or older Able to provide informed consent 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 Exclusion Criteria: Pregnancy or a positive pregnancy test on the day of enrollment Patients showing signs and symptoms of neurosyphilis Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin) Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test Self-reported allergy to cephalosporins or penicillin Unwilling or unable to attend follow-up visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey D Klausner
Phone
(415) 876-8901
Email
jdklausner@med.usc.edu
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey D Klausner, MD
Phone
415-876-8901
Email
jdklausner@med.usc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other researchers

Learn more about this trial

Cefixime Clinical Trial

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