NCT04958122

Brief Summary

This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
14mo left

Started Jun 2021

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Jun 2021Jun 2027

Study Start

First participant enrolled

June 20, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

5.5 years

First QC Date

June 29, 2021

Last Update Submit

April 27, 2026

Conditions

SyphilisHuman Immunodeficiency Virus

Keywords

CefiximeTreponema pallidumPenicillinEarly Syphilis

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (2)

Cefixime

EXPERIMENTAL

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

Drug: Cefixime 400mg

Benzathine Penicillin G

ACTIVE COMPARATOR

Single intramuscular injection of 2.4 million units of benzathine penicillin G

Drug: benzathine penicillin

Interventions

Cefixime 400mgDRUG

Oral cefixime 400 mg, one capsule, twice a day for 10 days

Also known as: supprax
Cefixime
benzathine penicillinDRUG

Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU

Also known as: bicillin
Benzathine Penicillin G

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90032, United States

RECRUITING

MeSH Terms

Conditions

SyphilisAcquired Immunodeficiency SyndromeTreponemal Infections

Interventions

CefiximePenicillin G Benzathine

Condition Hierarchy (Ancestors)

Spirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesHIV InfectionsBlood-Borne InfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPenicillin GPenicillins

Study Officials

  • Jeffrey D Klausner, MD MPH

    University of Southern California

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey D Klausner

CONTACT

(415) 876-8901jdklausner@med.usc.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 12, 2021

Study Start

June 20, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No IPD will be shared with other researchers

Locations

US(1)