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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

NCT02814916 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2024-09-19

Study results available
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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.

Conditions

Interventions

DRUG

Dalbavancin

Dalbavancin was administered intravenously over 30 (± 5) minutes.

DRUG

Vancomycin

Vancomycin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

DRUG

Oxacillin

Oxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

DRUG

Flucloxacillin

Flucloxacillin was administered intravenously over 60 (± 10) minutes every 6 (± 1) hours.

DRUG

Cefadroxil

Cefadroxil was administered orally every 12 hours.

DRUG

Clindamycin

Clindamycin was administered orally every 8 hours.

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2024-01-01
Completion
2024-01-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belarus
  • Brazil
  • Bulgaria
  • Chile
  • Colombia
  • Georgia
  • Greece
  • Guatemala
  • Latvia
  • Lithuania
  • Mexico
  • Panama
  • Poland
  • Romania
  • Russia
  • South Africa
  • Spain
  • Ukraine

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02814916 on ClinicalTrials.gov