Clinical Trial Details

NCT ID: NCT02814916
Date Last Changed: June 6, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using Dalbavancin single dose, Dalbavancin two dose and Comparator for patients with Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections or Staphylococcal Skin Infections

Research Study 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

Purpose

To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged 3 months to 17 years, known or suspected to be caused by susceptible Gram-positive organisms, including methicillin-resistant strains of Staphylococcus aureus.

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Recruitment Details

Phase
3
Gender
All
Age
3 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Durata Therapeutics Inc., an affiliate of Allergan plc
Duration
22 Months
Facility Type
N/A
Compensation

Eligibility

All ages 3 Months to 17 Years

Inclusion Criteria:

  • 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:

  • requires surgical incision and drainage, and

  • 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

  • alternatively, involves the central face and is associated with an area of erythema of at least 15 cm2

  • 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

  • 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

  • In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of ABSSSI:

  • Purulent drainage/discharge

  • Fluctuance

  • Heat/localized warmth

  • Tenderness to palpation

  • Swelling/induration

Exclusion Criteria:

  • Clinically significant renal impairment, defined as calculated creatinine clearance of less than 30 mL/min.

  • 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.

  • Treatment with an investigational drug within 30 days preceding the first dose of study medication.

  • 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.

  • Receipt of a systemically or topically administered antibiotic with a Gram-positive spectrum that achieves therapeutic concentrations in the serum or at the site of the skin infection within 14 days prior to randomization. An exception is allowed for patients receiving a single dose of a short-acting (half-life ≤ 12 hours) antibacterial drug prior to randomization.

  • 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).

  • Patients with necrotizing fasciitis, or deep-seated infections that would require > 2 weeks of antibiotics (e.g., endocarditis, osteomyelitis or septic arthritis).

  • 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.

  • 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. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, implantable pacemaker or defibrillator, intra-aortic balloon pump, left ventricular assist device, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.

  • Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia.

  • 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 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the skin infection, or patients who are expected to require more than 2 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).

  • Immunosuppression/immune deficiency, including hematologic malignancy, recent bone marrow transplant (in post-transplant hospital stay), absolute neutrophil count < 500 cells/mm3, receiving immunosuppressant drugs after organ transplantation, receiving oral steroids ≥ 20 mg prednisolone per day (or equivalent) for > 14 days prior to enrollment, and known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count < 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.

  • Known or suspected hypersensitivity to glycopeptide antibiotics, beta-lactam agents, aztreonam, or cephalosporins.

Site Locations (26)

Country State City Zip Facility and Contact
United States California Buena Park 90620 Southbay Pharma Research
United States Florida Panama City 32405 Global Research Holdings, LLC
United States Missouri Columbia 65212 University of Missouri Dermatology and Skin Surgery
United States New York Syracuse 13210 SUNY Upstate Medical University
Bulgaria Gabrovo Sevlievo 5400 Medical Center - 1 Sevlievo EOOD
Bulgaria Kozloduy 3320 MHAT (Multiprofile Hospital for Active Treatment)
Bulgaria Ruse 7002 MHAT (Multiprofile Hospital for Active Treatment) Ruse, AD Pediatric Department
Bulgaria Ruse 7002 Multiprofile Hospital for Active Treatment - Ruse AD, Ruse (MBAL Ruse)
Bulgaria Stara Zagora 6000 University Multiprofile Hospital for Active Treatment (UMHAT)
Colombia Antioquia Medellin 50010 Hospital San Vicente de Paul en Medellin
Colombia Antioquia Medellin 500515 Hospital General de Medellin Luz Castro de Gutierrez
Colombia Bogota 110131 Fundacion Cardio Infantil
Georgia Batumi 6010 LTD Unimedi Kakheti Batumi Maternal and Child Healthcare Center
Georgia Tbilisi 159 LEPL Tbilisi State Medical University Givi Zhvania Academic Clinic of Pediatry
Georgia Tbilisi 159 LTD M. Iashvili Children's Central Hospital
Georgia Tbilisi 159 LTD Unimedi Kakheti Children New Hospital
Latvia Kurzeme Liepaja LV-3414 Liepaja Regional Hospital
Latvia Daugavpils LV-5417 Daugavpils Regional Hospital
Latvia Riga LV-1004 Children's Clinical University Hospital
Lithuania Kaunas LT-50009 Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Lithuania Klaipeda LT- 92144 Klaipeda Children's Hospital
Lithuania Vilnius LT-08661 Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos
Spain Barcelona Esplugues de Llobregat 08950 Hospital Sant Joan de Déu
Spain Gipuzkoa Donostia-San Sebastian 20014 Hospital Universitario Donostia
Spain Madrid 28046 Hospital La Paz
Spain Santiago de Compostela 15076 Complejo Hospitalario Universitario de Santiago

Contact

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877-277-8566
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