WHO ICTRP trial
A clinical trial to compare different treatments for infection of bone and bone…
EUCTR2014-004130-25-ES · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2014-004130-25-ES |
|---|---|
| Public title | A clinical trial to compare different treatments for infection of bone and bone marrow caused by a local infection or an open traumatic fracture. The subjects will receive either study drug or local standard care. Neither the Physician nor the patient will be aware of which treatment arm they are receiving. The randomisation will be 2:1 Study drug vs standard care. |
| Scientific title | A phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be due to Gram-Positive Organisms |
| Primary sponsor | Durata Therapeutic International B.V. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;United States;Czech Republic;Spain;Ukraine;Romania;Russian Federation;Italy |
| Conditions | Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be due to Gram-Positive Organisms;Therapeutic area: Body processes [G] - Microbiological Phenomena [G06] |
| Interventions | Trade Name: Xydalba Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Dalbavancin CAS Number: 171500-79-1 Current Sponsor code: Dalbavancin Other descriptive name: n/a Concentration unit: mg… |
| Registration date | Jan 13, 2016 |
| Target size | 265 |
| Secondary IDs | DUR001-304 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: