drugset / Trial / NCT02814916
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
RandomizedParallel-groupOpen-labelTreatment
Summary
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.
Timeline
- Start
- 2017-03-30
- Primary completion
- 2024-01-01
- Completion
- 2024-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalbavancin | Other / unclassified | 6 mg/kg | Intravenous |
| Subject | Dalbavancin | Other / unclassified | 7.5 mg/kg | Intravenous |
| Subject | Dalbavancin | Other / unclassified | 18 mg/kg | Intravenous |
| Subject | Dalbavancin | Other / unclassified | 22.5 mg/kg | Intravenous |
| Comparator | FLOXACILLIN | Small molecule | 50 mg/kg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 10 mg/kg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |
| Comparator | oxacillin | Small molecule | 30 mg/kg | Intravenous |
| Comparator | Cefadroxil | Small molecule | 15 mg/kg | Oral |
| Comparator | Cefadroxil | Small molecule | 500 mg | Oral |
| Comparator | Cefadroxil | Small molecule | 1000 mg | Oral |
| Comparator | Clindamycin | Unknown | 10 mg/kg | Oral |