Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| 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 |
Trial team
| 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 |
DOCUMENTS
References
Clinicaltrials.gov:
Webpage:
Funding scheme