The DoPeNS study is a non-commercial, comparative effectiveness, open-label randomized controlled trial that will be the world's first randomized trial to evaluate treatments for neurosyphilis. We will randomize 308 individuals with a diagnosis of neurosyphilis at 30 centres in Belgium and the Netherlands to either oral doxycycline or intravenous penicillin therapy. Penicillin will be given on an inpatient basis for at least the first 7 days of therapy and then as outpatient therapy in a limited number of centres. Doxycycline is typically given as outpatient therapy. We will follow the participants up at 1.5, 3, 6 and 12 months. The primary outcome will be the proportion of individuals with an adequate serological response at 6 months post-treatment. An estimated 90% are expected to attain this adequate treatment response in both arms.
| Title | A randomised, multicentre, non-inferiority study of oral Doxycycline versus intravenous Penicillin for the treatment of NeuroSyphilis |
| Participants (P) | Patients ≥ 18 years with confirmed diagnosis of neurosyphilis |
| Intervention (I) | Oral doxycycline |
| Control (C) | Intravenous penicillin |
| Outcome (O) | Difference in proportion of participants with a two titre decline in serum rapid plasma reagin (RPR) at 6 months post-therapy commencement or normalization of serum RPR or normalization of CSF white cell count, and no treatment failure. |
| Trial Design | RCT |
| Sample Size | 308 patients (144 BE, 164 NL) |
| Trial duration | Study duration (FPI to CSR) 52 months |
| Budget | 1, 318, 000 |
| Sponsor | Institute of Tropical medicine |
| Chief Investigator | Prof Dr C Kenyon |
| External Partners | NCC: Leiden UMC |
| Number of participating sites | 30 sites, 13 in BE and 17 in NL |
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