Cefixime Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-20

Study Completion Date

2027-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Syphilis Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cefixime

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

Group Type EXPERIMENTAL

Cefixime 400mg

Intervention Type DRUG

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

Benzathine Penicillin G

Single intramuscular injection of 2.4 million units of benzathine penicillin G

Group Type ACTIVE_COMPARATOR

benzathine penicillin

Intervention Type DRUG

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

Interventions

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Cefixime 400mg

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

Intervention Type DRUG

benzathine penicillin

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

Intervention Type DRUG

Other Intervention Names

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supprax bicillin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No