Cefixime Versus Benzathine Penicillin G for Early Syphilis Treatment
Cefixime 400mg
+ Benzathine penicillin 2.4 million units
Urogenital Diseases+9
+ Genital Diseases
+ Bacterial Infections and Mycoses
Treatment Study
Summary
Study start date: July 13, 2021
Actual date on which the first participant was enrolled.This clinical trial is investigating whether a new antibiotic treatment, cefixime, is as effective and safe as the current standard treatment, benzathine penicillin G, for early syphilis. Syphilis is a sexually transmitted infection that needs timely and effective treatment to prevent complications. The study is important because it could provide a new treatment option for people who cannot receive penicillin, either due to allergies or because the injection is not available. It could also offer an oral alternative, making treatment easier in situations where injections are not practical. Participants in the study will be randomly assigned to receive either cefixime or benzathine penicillin G. Cefixime is taken orally, while benzathine penicillin G is given as an injection. The study will compare the effectiveness of these treatments in curing early syphilis and will monitor safety measures to ensure that the new treatment does not cause significant side effects. The goal is to see if cefixime can perform as well as the current standard treatment, potentially providing more flexibility in managing syphilis treatment. The study does not list specific primary outcomes, but it will focus on evaluating the efficacy and safety of the treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.61 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Národní referenční laboratoř pro syfilis, Státní zdravotní ústav
Prague, CzechiaOpen Národní referenční laboratoř pro syfilis, Státní zdravotní ústav in Google MapsFakultní nemocnice Bulovka
Prague, Czechia