Trial of the safety and efficacy of Dalbavancin versus Active Comparator in children with Skin Infections

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-333g2h
• Date of registration: 09/10/2017
• Prospective Registration: No
• Primary sponsor: Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro
• Public title: Trial of the safety and efficacy of Dalbavancin versus Active Comparator in children with Skin Infections
• Scientific title: 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
• Date of first enrolment: 31/10/2016
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-333g2h
• Study type: Intervention
• Study design: Treatment clinical trial, randomized controlled, phase 3, parallel, open label and three arms
• Phase: 3

Countries of recruitment

Argentina, Belarus, Brazil, Bulgaria, Chile, Colombia, Ecuador, Georgia, Greece, Guatemala, Latvia, Lithuania, Panama, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine

Contacts

• Name: Fabio de Araujo Motta
• Affiliation: Núcleo de Pesquisa Clínica do Hospital Pequeno Príncipe

• Name: Livia Gomes
• Affiliation: Inc Research Br Serviços de Pesquisa Clínica LTDA

Key inclusion & exclusion criteria

Inclusion criteria: Male or female. Age between 3 months and 17 years. Clinical compatible with infection caused or suspected to be caused by bacteria. Fever, Low leukocytes, cutaneous abscess (pus on the skin), accompanied by redness, edema and/or induration, surgical or traumatic wound infection.
Having: drainage / secretion of pus; fluctuation, localized heat / heat; sensitivity to palpation and / or swelling / induration.
Exclusion criteria: Clinically significant renal impairment; Clinically significant hepatic impairment; treatment with an investigational drug within 30 days preceding the first dose of
study medication; Patients with low blood arterial pressure; Receipt of antibiotic within 14 days prior to randomization; An exception is allowed for patients
receiving a single dose of antibacterial drug; Patients with necrotizing fasciitis, or deep-seated infections that would require more than two weeks of antibiotics and and infections caused by fungi, in combination with a bacterial pathogen; Venous catheter entry site infection; Infections involving diabetic foot ulceration, perirectal abscess or a decubitus ulcer; Patient with an infected device, even if the device is removed; Patients whose skin infection is the result of having sustained full or partial thickness burns;
Patients with uncomplicated skin infections such as superficial/simple
cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure.
Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study. Sickle cell anemia
Cystic fibrosis. Anticipated need of antibiotic therapy for longer than 14 days. Patients who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI. More than two surgical interventions for the skin infection, or patients who are expected to require more than two such interventions.
Medical conditions in which chronic inflammation may preclude assessment of
clinical response to therapy even after successful treatment (e.g., chronic stasis
dermatitis of the lower extremity).


Age minimum: 3M
Age maximum: 17Y
Gender: -

Health Condition(s) or Problem(s) studied

L03.0

L05.0

Staphylococcal scalded skin syndrome. Impetigo [any organism] [any site]. Cutaneous abscess, furuncle and carbuncle of face. Cellulitis of finger and toe. Acute lymphadenitis of face, head and neck. Pilonidal cyst with abscess. Pyoderma.

L01.0

L02.0

L08.0

L04.0

Intervention(s)

Drug

D27.505.954.122.085

300 patients will be randomized in a 1:1:1 randomization scheme:
Group 1: Dalbavancin, intravenous, single dose, calculated according to the age;
Group 2: Dalbavancin, intravenous; administered on day 1 and day 8, dose calculated according to the age;
Group 3/Comparator: Vancomycin, oxacillin or flucloxacillin, every 6 hours, for 10-14 days.

N04.452.706.477

Primary Outcome(s)

To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections known or suspected to be caused by susceptible Gram-positive organisms, including methicillinresistant
strains of Staphylococcus aureus. Safety will be assessed by means of physical examination and vital signs, collection of
adverse events and clinical laboratory tests.Safety results and adverse events will be tabulated by separate treatment regimens, including those who did and did not receive additional agents. the evaluations will be done between 48 and 72 hours after randomization, 14, 28 and 54 days after the end of treatment.

Secondary Outcome(s)

To assess clinical response at 48-72 hours post randomization measured in patients who did not receive rescue therapy and are alive; and clinical response based on the global
clinical assessment by the investigator at end of treatment (14 ± 2 days after start of therapy); at test of cure visit (28 ± 2 days after start of therapy), and at last follow-up visit (54 ± 7 days after start of therapy) in the mITT, CE-EOT, CE-TOC and CEFollow-up visit populations.
To assess clinical response by baseline pathogen at 48-72 hours post randomization); and clinical response based on the global clinical assessment by the investigator at end of treatment (14 ± 2 days after start of therapy), at test of cure visit (28 ± 2 days after start of therapy), and at last follow-up visit (54 ± 7 days after start of therapy) microITT population.
To evaluate the pharmacokinetics (PK) of dalbavancin in pediatric patients aged 3 months to 17 years of age.
The evaluations will be done by clinical and physical exams and laboratory samples.

Source(s) of Monetary Support

Durata Therapeutics International B.V.

Inc Research Br Serviços de Pesquisa Clínica LTDA

Secondary Sponsor(s)

Durata Therapeutics International B.V.

Inc Research Br Serviços de Pesquisa Clínica LTDA