drugset / Trial / NCT00299520
Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).
Timeline
- Start
- 2005-06
- Primary completion
- —
- Completion
- 2006-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Linezolid | Other / unclassified | — | Intravenous |
| Subject | iclaprim | Small molecule | — | Intravenous |
Indications
No indication recorded.