Cefixime for Alternative Syphilis Treatment

NCT03660488 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 18-00066520181796
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 10

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.

Conditions

Syphilis; Early Syphilis

Keywords

syphilis; cefixime; penicillin

Outcome Measures

Primary Outcomes (1)

• Treatment Response

  subjects who have a 4-fold decrease (from study entry Rapid plasma reagin) in Rapid plasma reagintiters from baseline at 3 or 6 months will be considered a positive treatment response.

  3 or 6 months after treatment completion

Study Arms (2)

Benzathine Penicillin G

ACTIVE COMPARATOR

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

Cefixime Group

EXPERIMENTAL

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]

Interventions

Cefixime 400 milligram Oral Capsule [Suprax] DRUG

The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days

Also known as: Suprax

Cefixime Group

Benzathine Penicillin G DRUG

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

Benzathine Penicillin G

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older and able to provide informed consent
• Cases of primary, secondary or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment.
• Non-cephalosporin allergic
• 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
• Able to swallow pills

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• AIDS Healthcare Foundation: collaborator

Study Sites (10)

AHF Westside

Beverly Hills, California, 90211, United States

Location

AHF Downtown Healthcare Center

Los Angeles, California, 90015, United States

Location

AHF Carl Bean

Los Angeles, California, 90018, United States

Location

AHF Hollywood Healthcare Center

Los Angeles, California, 90027, United States

Location

AHF Wellness on Western Center

Los Angeles, California, 90027, United States

Location

AHF Oakland Wellness Center

Oakland, California, 94606, United States

Location

AHF Healthcare Center Oakland

Oakland, California, 94609, United States

Location

AHF San Francisco

San Francisco, California, 94114, United States

Location

AHF Valley

Sherman Oaks, California, 91403, United States

Location

AHF Las Vegas Healthcare Center

Las Vegas, Nevada, 89109, United States

Location

Related Publications (1)

• Mehta SN, Stafylis C, Tellalian DM, Burian PL, Okada CM, Millner CE, Mejia CM, Klausner JD. Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis. Trials. 2020 Dec 9;21(1):1009. doi: 10.1186/s13063-020-04885-z.

  PMID: 33298143 DERIVED

MeSH Terms

Conditions

Syphilis

Interventions

Cefixime; Penicillin G

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillins

Results Point of Contact

• Title: Jeffrey D Klausner MD MPH, Clinical Professor of Population and Public Health Sciences
• Organization: University of Southern California

jdklausner@med.usc.edu

4158768901

Study Officials

• Jeffrey D Klausner, MD MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• David Tellalian, MD

  AIDS Helthcare Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine & Public Health

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: September 3, 2018
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: July 26, 2022
• Results First Posted: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)