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Cefixime for Alternative Syphilis Treatment

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ClinicalTrials.gov Identifier: NCT03660488
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
AIDS Healthcare Foundation
Information provided by (Responsible Party):
Jeffrey D. Klausner, MD, MPH, University of California, Los Angeles

Brief Summary:

The goal of the study is to evaluate the efficacy of oral cefixime as an alternative treatment for syphilis infection.

One hundred adult patients (≥18 years old) with syphilis infection (positive Treponema Pallidum Particle Agglutination assay and RPR titer ≥ 1/8) will be recruited. Participants will be randomized (1:1) to receive either the standard of care Penicillin or Cefixime.

During the study, participants will visit the clinic up to 5 times; at baseline visit, at 3, 6, 12 months after treatment initiation. Participants of the cefixime group will be required to visit the clinic 14 days after treatment initiation. In each visit, participants will be asked about current symptoms and do laboratory tests for syphilis (RPR). Subjects who have a 4-fold decrease (from study entry RPR) in RPR titers from baseline at 6 months will be considered a positive treatment response.


Condition or disease Intervention/treatment Phase
Syphilis Early Syphilis Drug: Cefixime 400 milligram Oral Capsule [Suprax] Drug: Benzathine Penicillin G Phase 2

Detailed Description:

Syphilis is a major issue worldwide causing 5.6 million new cases of syphilis worldwide, of which over 900,000 are pregnant women. It is also responsible for congenital infections causing fetal loss or stillbirth or, in a live-born infant, neonatal death, prematurity and low birth weight. Penicillin is the currently used treatment. However, lack of penicillin and alternatives to treatment often hinder treatment and prevention efforts.

Cefixime is an FDA-approved, orally administered third-generation cephalosporin that is currently used for the treatment of a wide range of infections, including urinary tract infections. Our goal is to evaluate the efficacy and safety of oral cefixime as an alternative treatment for syphilis infection.

One hundred adult patients (≥18 years old) with syphilis infection will be recruited. Eligible participants will have laboratory-confirmed syphilis infection with a positive Treponema pallidum Particle Agglutination (TPPA) assay and RPR (Rapid Plasma Reagin ) titer ≥ 1/8. Participants will be randomized (1:1) to receive either the standard of care Penicillin or Cefixime.

During the study, participants will visit the clinic 5 times; at baseline visit, demographic, clinical information and laboratory test results for syphilis will be recorded and treatment will start. Depending on the study group, the treatment plan will be oral Cefixime 400mg, twice per day for ten consecutive days or one dose of intramuscular Penicillin. Patients will be required to visit the clinic two weeks after treatment initiation to verify adverse effects. Follow up visits will occur at 3, 6 and 12 months after treatment initiation. In each visit, participants will be asked about current symptoms, interval sexual history, concomitant antibiotic use and possible adverse reactions. Subjects will also have a venipuncture blood specimen collected for syphilis testing (RPR). Subjects who have a 4-fold decrease (from study entry RPR) in RPR titers from baseline at 6 months will be considered a positive treatment response.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021


Arm Intervention/treatment
Active Comparator: Benzathine Penicillin G
Patients of the "Penicillin Group" will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients.
Drug: Benzathine Penicillin G
The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection

Experimental: Cefixime Group

Patients of the "Cefixime Group" will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication.

The group will consist of 50 patients.

Drug: Cefixime 400 milligram Oral Capsule [Suprax]
The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days
Other Name: Suprax




Primary Outcome Measures :
  1. Treatment response [ Time Frame: 6 months after treatment completion ]
    subjects who have a 4-fold decrease (from study entry RPR) in RPR titers from baseline at 3 or 6 months will be considered a positive treatment response.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older and able to provide informed consent
  2. Cases of primary, secondary or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment.
  3. HIV infected individuals willing to participate in the study must have CD4 count ≥350 cells/μl within the last 4 weeks and be virally suppressed (i.e., viral load ≤ 200 copies/mL) for HIV for the 6 months prior to enrolment with the most recent results within the last 4 weeks. inclusion
  4. Non-cephalosporin allergic
  5. Able to travel to the clinic once a day or be available for phone calls or receive text messages for at least 7-10 days and willing to attend follow-up visits
  6. Able to swallow pills

Exclusion Criteria:

  1. Pregnancy or positive pregnancy test
  2. Serofast RPR titer (prior titer 1:8 or greater)
  3. Recent (less than 7 days) or concomitant antimicrobial therapy with activity against syphilis.
  4. Cephalosporin allergy: previous episode of flushing, urticaria, angioedema, rhinitis, bronchospasm, and anaphylactic shock, rash after taking cephalosporin.
  5. Penicillin allergy: previous episode of flushing, urticaria, angioedema, rhinitis, bronchospasm, and anaphylactic shock, rash after receiving Penicillin.
  6. Has a medical condition or other factor that might affect their ability to follow the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660488


Contacts
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Contact: Jeffrey D Klausner, MD MPH 3107943221 jdklausner@mednet.ucla.edu
Contact: Chrysovalantis Stafylis, MD MPH cstafylis@mednet.ucla.edu

Locations
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United States, California
AHF Westside Recruiting
Beverly Hills, California, United States, 90211
Contact: Carl Millner, MD         
AHF Downtown Healthcare Center Recruiting
Los Angeles, California, United States, 90015
Contact: David Tellalian, MD       david.tellalian@aidshealth.org   
AHF Carl Bean Recruiting
Los Angeles, California, United States, 90018
Contact: David Tellalian, MD         
AHF Hollywood Healthcare Center Recruiting
Los Angeles, California, United States, 90027
Contact: Pam Burian, PA         
AHF Wellness on Western Center Recruiting
Los Angeles, California, United States, 90027
Contact: Cliff Okada, MD         
AHF Oakland Wellness Center Recruiting
Oakland, California, United States, 94606
Contact: Christopher Mejia, MPH         
AHF Healthcare Center Oakland Recruiting
Oakland, California, United States, 94609
Contact: Seth Glassman, MD         
AHF San Francisco Recruiting
San Francisco, California, United States, 94114
Contact: Seth Glassman, MD         
AHF Valley Recruiting
Sherman Oaks, California, United States, 91403
Contact: James Carroll, MD         
United States, Nevada
AHF Las Vegas Healthcare Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Warren Magnus, MD         
Sponsors and Collaborators
University of California, Los Angeles
AIDS Healthcare Foundation
Investigators
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Principal Investigator: Jeffrey D Klausner, MD MPH University of California, Los Angeles
Principal Investigator: David Tellalian, MD AIDS Helthcare Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeffrey D. Klausner, MD, MPH, Professor of Medicine & Public Health, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03660488    
Other Study ID Numbers: 18-000665
20181796 ( Other Identifier: Western IRB )
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the sensitive nature of the data, participant data will not be provided or shared with other researchers, apart from the members of the research team or regulatory authorities

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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
Keywords provided by Jeffrey D. Klausner, MD, MPH, University of California, Los Angeles:
syphilis
cefixime
penicillin
Additional relevant MeSH terms:
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Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Penicillins
Cefixime
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Anti-Bacterial Agents
Anti-Infective Agents