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



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any - 17
Updated:6/9/2018
Start Date:March 30, 2017
End Date:January 25, 2019
Contact:Clinical Trial Registries Team
Email:IR-CTRegistration@allergan.com
Phone:877-277-8566

Use our guide to learn which trials are right for you!

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

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.


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:

1. 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

2. 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:

1. Major cutaneous abscess characterized as a collection of pus within the dermis or
deeper that is accompanied by erythema, edema and/or induration which:

1. requires surgical incision and drainage, and

2. 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

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

2. 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

3. 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:

1. Purulent drainage/discharge

2. Fluctuance

3. Heat/localized warmth

4. Tenderness to palpation

5. 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.
We found this trial at
19
sites
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2619 E. Pierce St.
Phoenix, Arizona 85008
602-344-5951
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Buena Park, California 90620
?
mi
from
Buena Park, CA
Click here to add this to my saved trials
1020 Hitt Street
Columbia, Missouri 65212
?
mi
from
Columbia, MO
Click here to add this to my saved trials
3901 Beaubien Street
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Jenkintown, Pennsylvania 19046
?
mi
from
Jenkintown, PA
Click here to add this to my saved trials
Kansas City, Kansas 64108
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
9425 Southwest 72nd Street
Miami, Florida 33173
?
mi
from
Miami, FL
Click here to add this to my saved trials
307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
University of South Alabama "University of South Alabama is a public institution that was founded...
?
mi
from
Mobile, AL
Click here to add this to my saved trials
550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
?
mi
from
New York, NY
Click here to add this to my saved trials
Panama City, Florida 32405
?
mi
from
Panama City, FL
Click here to add this to my saved trials
?
mi
from
Sevlievo,
Click here to add this to my saved trials
750 East Adams Street
Syracuse, New York 13210
?
mi
from
Syracuse, NY
Click here to add this to my saved trials