Comparison between Ceftriaxone and Crystalline Penicillin for the treatment of Ocular Syphilis

Ceftriaxone versus Crystalline Penicillin for the treatment of ocular Syphilis: a randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-92wcttd

Enrollment

Unknown

Registered

2025-04-03

Start date

2025-01-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syphilis, unspecified

Interventions

This is a two-arm randomized controlled clinical trial. Participants in group A will undergo treatment with crystalline penicillin 4 million units IV every 4 hours for 14 days. Participants in group B

D02.065.589.099.249.190.190.155

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals, male or female; over 18 years of age diagnosed with ocular syphilis

Exclusion criteria

Exclusion criteria: History of previously treated syphilis; allergy to penicillin or cephalosporin; immunocompromised individuals not infected with the Human Immunodeficiency Virus (HIV); concomitant severe eye disease that may compromise the analysis of response to treatment of syphilis uveitis (e.g., diabetic macular edema, age-related macular degeneration, previous blindness for other reasons); refusal to participate in the study

Design outcomes

Primary

Measure	Time frame
To evaluate the non-inferiority of ceftriaxone compared to crystalline penicillin in the treatment of ocular syphilis in clinical and laboratory terms. Clinical success will be considered: improvement in visual acuity (gain of 10 letters in relation to the first evaluation); improvement in inflammation (decrease in intraocular inflammation by 2+ cells in the anterior chamber or vitreous haze or decrease in parameters to "zero", following criteria of The SUN Working Group Activity of Uveitis Terminology); anatomical improvement on optical coherence tomography examination - restructuring of the outer layers and/or reduction in the central subfield thickness by 10%; improvement in image patterns on fluorescein angiography demonstrating inactive vasculitis. Laboratory success will be considered: drop of two VDRL titers 6 months after treatment.	—

Measure

Time frame

To evaluate the non-inferiority of ceftriaxone compared to crystalline penicillin in the treatment of ocular syphilis in clinical and laboratory terms. Clinical success will be considered: improvement in visual acuity (gain of 10 letters in relation to the first evaluation); improvement in inflammation (decrease in intraocular inflammation by 2+ cells in the anterior chamber or vitreous haze or decrease in parameters to "zero", following criteria of The SUN Working Group Activity of Uveitis Terminology); anatomical improvement on optical coherence tomography examination - restructuring of the outer layers and/or reduction in the central subfield thickness by 10%; improvement in image patterns on fluorescein angiography demonstrating inactive vasculitis. Laboratory success will be considered: drop of two VDRL titers 6 months after treatment.

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Secondary

Measure	Time frame
No secondary outcomes are expected.	—

Countries

Brazil

Contacts

Public ContactRoberto Reis

Roberto dos Reis

rdreis@unicamp.br+55(19)35212121

Outcome results

None listed

Source: REBEC (via WHO ICTRP)