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Comparison · NCT03660488-sae

Benzathine Penicillin G vs Cefixime Group: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Benzathine Penicillin G vs Cefixime Group: serious adverse events. Trial comparisons, record NCT03660488-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03660488-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.11wilson
Risk in group 20.0370.006570.183wilson
Risk difference, group 1 minus group 2-0.037-0.1830.0774newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer participant with a serious adverse event on Benzathine Penicillin G than on Cefixime Group27from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Benzathine Penicillin G
Patients of the Penicillin Group will receive the standard of care treatment. This is one intramuscular injection of 2.4 million units Benzathine Penicillin G. The group will consist of 50 patients.~Benzathine Penicillin G: The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection
031EG000
Group 2Cefixime Group
Patients of the Cefixime Group will receive Cefixime 400 mg, per os, one tablet, two times per day, for ten consecutive days. The study team will provide the medication.~The group will consist of 50 patients.~Cefixime 400 milligram Oral Capsule \[Suprax\]: The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days
127EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse event data were collected throughout the duration of the study (12 months) starting from enrollment. Evaluation for adverse events occurred during follow ups; for the cefixime group we evaluated adverse events during the 10-day visit. Participants and study clinicians were instructed to report any occurrence to the study team for review.

Source ClinicalTrials.gov

Trial

Title
Cefixime for Alternative Syphilis Treatment
NCT number
NCT03660488
Phases
PHASE2
Conditions
Syphilis, Early Syphilis
Interventions
Cefixime 400 milligram Oral Capsule [Suprax], Benzathine Penicillin G
Lead sponsor
University of California, Los Angeles
Results first posted
2022-07-26

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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