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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

NCT02814916•AbbVie

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients birth to 17 years (inclusive)
•A clinical picture compatible with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) suspected or confirmed to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA).
•In addition to local signs of ABSSSI, the patient has at least one of the following:
•Fever, defined as body temperature ≥ 38.4°C (101.2°F) taken orally, ≥ 38.7°C (101.6°F) tympanically, or ≥ 39°C (102.2°F) rectally (core temperature) OR
•Leukocytosis (WBC \> 10,000 mm3) or leukopenia (WBC \< 2,000 mm3) or left shift of \>10% band neutrophils
•Infection either involving deeper soft tissue or requiring significant surgical intervention
•Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which i. requires surgical incision and drainage, and ii. is associated with cellulitis such that the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR iii. alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2 b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that: i. the total affected area involves at least 35 cm2 of erythema, or total affected area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, involves the central face and is associated with an affected area of at least 15 cm2 c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and: i. is associated with erythema that involves at least 35 cm2 of surface area, or surface area of erythema is at least BSA (m2) x 43.0 (cm2/m2), OR ii. alternatively, cellulitis of the central face that is associated with an affected area of at least 15 cm2 5. In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI: a. Purulent drainage/discharge b. Fluctuance c. Heat/localized warmth d. Tenderness to palpation e. Swelling/induration
•1. Male or female patients from birth to \< 3 months of age, including pre-term neonates (gestational age ≥ 32 weeks)
•2. A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA.
•OR
+25 more criteria

Exclusion Criteria

•1. Patients age 3 months to 17 years: Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min. (calculated by the Schwartz "bedside" formula). Patients birth to \< 3 months of age: Moderate or severe renal impairment defined as serum creatinine ≥ 2 times the upper limit of normal (× ULN) for age OR urine output \< 0.5 mL/kg/h (measured over at least 8 hours prior to dosing) OR requirement for dialysis.
•2. Clinically significant hepatic impairment, defined as serum bilirubin or alkaline phosphatase greater than 2 times the upper limits of normal (ULN) for age, and/or serum aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal (ULN) for age.
•3. Treatment with an investigational drug within 30 days preceding the first dose of study medication.
•4. Patients with sustained shock defined as systolic blood pressure \< 90 mm Hg in children ≥ 10 years old, \< 70 mm Hg + \[2 x age in years\] in children 1 to \<10 years, or \< 70 mmHg in infants 3 to \<12 months old for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
•5. More than 24 hours of any systemic antibacterial therapy within 96 hours before randomization. EXCEPTION: Microbiological or clinical treatment failure with a systemic antibiotic other than IV study drug that was administered for at least 48 hours. Failure must be confirmed by either a microbiological laboratory report or documented worsening clinical signs or symptoms.
•6. Infection due to an organism known prior to study entry to be resistant to dalbavancin (dalbavancin minimum inhibitory concentration (MIC) greater than 0.25 ug/mL) or vancomycin (vancomycin minimum inhibitory concentration (MIC) greater than 2 ug/mL).
•7. Patients with necrotizing fasciitis, or deep-seated infections that would require \> 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis).
•8. Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
•9. Venous catheter entry site infection.
•10. Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
+16 more criteria

Locations (84)

University of South Alabama /ID# 237446

Mobile, Alabama, United States

Valleywise Health Medical Center /ID# 234343

Phoenix, Arizona, United States

Southbay Pharma Research /ID# 235700

La Palma, California, United States

University of California, Los Angeles /ID# 237533

Los Angeles, California, United States

Duplicate_Children's Hospital Colorado /ID# 237622

Aurora, Colorado, United States

Global Research Holdings LLC /ID# 235747

Panama City, Florida, United States

Tampa General Hospital /ID# 237061

Tampa, Florida, United States

Children's Healthcare of Atlanta - Ferry Rd /ID# 237003

Atlanta, Georgia, United States

University of Maryland Medical Center /ID# 234353

Baltimore, Maryland, United States

Duplicate_Children's Mercy Hospital and Clinics /ID# 237800

Kansas City, Missouri, United States

Key Dates

Start Date

March 30, 2017

Primary Completion Date

January 1, 2024

Completion Date

January 1, 2024

Last Updated

September 19, 2024

Enrollment

199

ACTUAL participants

Conditions

Methicillin-Resistant Staphylococcus AureusBacterial InfectionsStaphylococcal Skin Infections

Interventions

Dalbavancin

DRUG

Vancomycin

DRUG

Oxacillin

DRUG

Flucloxacillin

DRUG

Cefadroxil

DRUG

Clindamycin

DRUG

[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects

NCT04263792

Bacterial Infections

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Multidrug Resistant Bacterial InfectionEnterobacteriaceae Infections+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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