Cefixime Clinical Trial | NCT04958122

Studies
Cefixime Clinical Trial

NCT04958122

Sponsor

University of Southern California

Status

Recruiting

Last Update Posted

May 4, 2026Actual

Enrollment

400Estimated

Phase

Phase 3

Conditions

Syphilis
Human Immunodeficiency Virus

Interventions

Cefixime 400mg
benzathine penicillin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2021Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Jun 29, 2021

First Submission Date that Met QC Criteria

Jun 29, 2021

First Posted Date

Jul 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

May 4, 2026Actual

Name	Class
AIDS Healthcare Foundation	OTHER
Universidad Peruana Cayetano Heredia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cefixime 400mg	Drug	Oral cefixime 400 mg, one capsule, twice a day for 10 days	Cefixime

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeffrey D Klausner	Contact	(415) 876-8901		jdklausner@med.usc.edu

Overall Officials

Name	Affiliation	Role
Jeffrey D Klausner, MD MPH	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California	Recruiting	Los Angeles	California	90032	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No IPD will be shared with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013587	Syphilis
D000163	Acquired Immunodeficiency Syndrome
D014211	Treponemal Infections

Ancestor Terms

ID	Term
D013145	Spirochaetales Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020682	Cefixime
D010401	Penicillin G Benzathine

Ancestor Terms

ID	Term
D002439	Cefotaxime
D002505	Cephacetrile
D002511	Cephalosporins
D047090	beta-Lactams

Browse Leaves

Not provided

Browse Branches

Not provided