Trial reportThe New England journal of medicine2025
One Dose versus Three Doses of Benzathine Penicillin G in Early Syphilis.
Trial report in The New England journal of medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03637660 (A Phase 4 Comparative Trial of Benzathine Penicillin G 2.4 Million Units Administered as a Single Dose Versus Three Successive Weekly Doses for Treatment of Early Syphilis in Subjects With or Without HIV Infection), which is not on this map. Cited by 9 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 4 Comparative Trial of Benzathine Penicillin G 2.4 Million Units Administered as a Single Dose Versus Three Successive Weekly Doses for Treatment of Early Syphilis in Subjects With or Without HIV Infection
Who cites it
9 citing papers in PubMed.
- Single-dose Ceftriaxone Plus 7-Day Doxycycline Versus Single-dose Benzathine Penicillin G Plus 7-Day Doxycycline in the Treatment of Early Syphilis in People With HIV: a Pilot Randomized Noninferiority Trial.Open forum infectious diseases · 2026Trial
- Comparable treatment response rates with benzathine penicillin and doxycycline in early syphilis: evidence from a large German cohort.Infection · 2026Article
- The Global Syphilis Epidemic: Turning the Tide.Sexually transmitted diseases · 2026Article
- Mechanisms, management and prevention of anorectal sexually transmitted infections.Nature reviews. Gastroenterology & hepatology · 2026Review
- Clinical application of benzathine penicillin G as secondary prophylaxis and vaccines for patients with acute rheumatic fever and rheumatic heart disease: A comprehensive review.International journal of cardiology. Congenital heart disease · 2026Review
- Analysis of the spatio-temporal pattern and evolutionary trends of syphilis at township level in Xining City, Qinghai Province, China from 2008 to 2024.Scientific reports · 2026Article
- Susceptibility to Penicillin G and Ceftriaxone in 3 Clinical Treponema pallidum Isolates Is Not Altered by Amino Acid Polymorphisms in the Tp0705 Penicillin Binding Protein.Sexually transmitted diseases · 2026Article
- A machine learning model for predicting adverse prognostic events in patients with neurosyphilis: Results from the DEFEAT-NS study.iScience · 2026Article
- Antiquated Tools to Fight an Ancient Foe.The New England journal of medicine · 2025Article
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundControversy persists regarding the appropriate duration of therapy with benzathine penicillin G in persons with early (i.e., primary, secondary, or early latent) syphilis (
methodsIn a multicenter, randomized, controlled, noninferiority trial, we assigned persons who had early syphilis, with or without human immunodeficiency virus (HIV) infection, to receive intramuscular injections of benzathine penicillin G in a one-time dose of 2.4 million units or in doses of 2.4 million units administered at three successive weekly intervals. The primary end point was seroreversion to nonreactive status or a decrease in the rapid plasma reagin titer by two or more dilutions at 6 months, referred to here as a serologic response (noninferiority margin, 10 percentage points). A key secondary end point was a serologic response within subgroups defined according to HIV status, also assessed in a noninferiority analysis.
resultsA total of 249 persons with early syphilis were enrolled. Most participants were men (97%), 62% were Black, and 153 (61%) were living with HIV infection. The distribution according to syphilis stage was 19% with primary syphilis, 47% with secondary syphilis, and 33% with early latent syphilis. The percentage of participants with a serologic response at 6 months was 76% (95% confidence interval [CI], 68 to 82) in the single-dose group and 70% (95% CI, 61 to 77) in the three-dose group (difference, -6 percentage points; 90% CI, -15 to 3, indicating noninferiority). No clinical relapse or treatment failure occurred in either group. In the one-dose group, a serologic response at 6 months was observed in 76% of participants who had HIV infection and 76% of those who did not, and in the three-dose group, a serologic response at 6 months was observed in 71% of participants who had HIV infection and 70% of those who did not. Most participants in each group had local injection-site pain and tenderness with treatment (76% with a single dose and 85% with three doses).
conclusionsTreatment with one dose of 2.4 million units of benzathine penicillin G was noninferior to treatment with three doses with regard to serologic response 6 months after treatment. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT03637660.).
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