drugset / Trial / NCT06907316
Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis
Phase 4
Terminated
61 enrolled
Bulovka Hospital
Národní referenční laboratoř pro syfilis, Státní zdravotní ústav · collabVšeobecná fakultní nemocnice Praha · collabÖrebro University, Sweden · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This study evaluates the efficacy (non-inferiority) and safety of a new antibiotic treatment (cefixime), which has been previously used for single dose therapy of gonorrhoea in many years , in the treatment of early syphilis. Participants will be randomized to one of two study arms and will receive either expirimental regimen (cefixime) or the current standard antibiotic regimen (benzathine penicillin G). New treatment alternatives for syphilis could ensure that people are appropriately treated during periods or in settings of benzathine penicillin G stock out, penicillin allergy, or other intolerance to penicillin injection. This study may also identify an oral regimen for settings in which injections are not feasible.
Timeline
- Start
- 2021-07-13
- Primary completion
- 2024-08-01
- Completion
- 2024-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Benzathine Penicillin G | Unknown | 2.4 iu | Intramuscular |
| Subject | Cefixime | Other / unclassified | 400 mg | Oral |