CLINICAL TRIALS PROFILE FOR DALBAVANCIN HYDROCHLORIDE
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All Clinical Trials for DALBAVANCIN HYDROCHLORIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00057369 ↗ | Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections | Unknown status | Vicuron Pharmaceuticals | Phase 2 | 2001-02-01 | This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin. |
| NCT00678106 ↗ | Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections | Completed | Pfizer | Phase 1 | 2008-09-01 | Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1 gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be measured at different time points. Safety labs will also be checked on a regular basis to assess the safety of dalbavancin. |
| NCT01339091 ↗ | Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections | Completed | Durata Therapeutics Inc., an affiliate of Allergan plc | Phase 3 | 2011-03-01 | The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection. |
| NCT01431339 ↗ | Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections | Completed | Durata Therapeutics Inc., an affiliate of Allergan plc | Phase 3 | 2011-07-01 | The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections. |
| NCT01946568 ↗ | A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years. | Completed | Durata Therapeutics Inc., an affiliate of Allergan plc | Phase 1 | 2013-06-01 | A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin. |
| NCT02127970 ↗ | Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections | Completed | Durata Therapeutics Inc., an affiliate of Allergan plc | Phase 3 | 2014-04-18 | To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment. |
| NCT02269644 ↗ | A P3 Comparator Trial in Community Acquired Bacterial Pneumonia | Withdrawn | Durata Therapeutics Inc., an affiliate of Allergan plc | Phase 3 | 2015-11-01 | This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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