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
  • End date
    Dec 31, 2021
  • participants needed
    212
  • sponsor
    Allergan
Updated on 24 January 2021
platelet count
antibiotic therapy
antibiotics
abscess
drainage
fever
cellulitis
ABSSI
fluctuance
methicillin
staphylococcus aureus
vancomycin
induration
wound infection
tenderness
surgical incision
dalbavancin
absolute neutrophil count
procalcitonin
leukopenia
MRSA
erosion
staphylococcus
erysipelas
metabolic acidosis
systemic infection
neutrophils
lethargy
impetigo
pustular folliculitis
streptococcal toxic shock syndrome

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.

Details
Condition Bacterial Infection, Staphylococcal infection, Staphylococcal Skin Infection, MRSA, Staphylococcal Infections, Bacterial Infections, Staphylococcal Skin Infections, methicillin-resistant staphylococcus aureus infection, bacterial disease
Treatment Dalbavancin single dose, Dalbavancin two dose, Comparator
Clinical Study IdentifierNCT02814916
SponsorAllergan
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

In patients age 3 months to 17 years (inclusive)
Male or female patients 3 months 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 38.4C (101.2F) taken orally, 38.7C (101.6F) tympanically, or 39C (102.2F) 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
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
In patients age birth to < 3 months, each patient must meet the following inclusion criteria to be enrolled in this study
Male or female patients from birth to < 3 months of age, including pre-term neonates (gestational age 32 weeks)
A clinical picture compatible with an ABSSSI suspected or confirmed to be caused by Gram-positive bacteria, including MRSA
OR
Suspected or confirmed sepsis including any of the following clinical
criteria
Hypothermia (<36C) OR fever (>38.5C)
Bradycardia OR tachycardia OR rhythm instability
Hypotension OR mottled skin OR impaired peripheral perfusion
Petechial rash
New onset or worsening of apnea episodes OR tachypnea episodes OR increased oxygen requirements OR requirement for ventilation support
Feeding intolerance OR poor sucking OR abdominal distension
Irritability
Lethargy
Hypotonia
In addition, patients must meet at least one of the following laboratory
criteria
White blood cell count 4.0 109/L OR 20.0 109/L
Immature to total neutrophil ratio >0.2
Platelet count 100 109/L
C-reactive protein (CRP) >15 mg/L OR procalcitonin 2 ng/mL
Hyperglycemia OR Hypoglycemia
Metabolic acidosis
Infections must be of sufficient severity to merit hospitalization and parenteral antibiotic therapy. These infections may include
Cutaneous or subcutaneous abscess
Surgical site or traumatic wound infection
Cellulitis, Erysipelas
Omphalitis
Impetigo and bullous impetigo
Pustular folliculitis
Scarlet fever
Staphylococcal scalded skin syndrome
Streptococcal toxic shock syndrome
Erythematous based-erosion
Other infections originating in the skin or subcutaneous tissue and associated with signs and symptoms of sepsis as defined in Inclusion Criterion 2
Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study

Exclusion Criteria

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
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
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
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, intraaortic 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 age 3 months to 17 years, with uncomplicated skin infections such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure. Patients birth to < 3 months of age may be enrolled if they have uncomplicated skin infections of sufficient severity to require hospitalization and parenteral antibiotic therapy
Patients age 3 months to 17 years: 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, betalactam agents, aztreonam, or cephalosporins
Patients with a rapidly fatal illness, who are not expected to survive for 3 months
Positive urine (or serum) pregnancy test at screening (post-menarchal females only) or after admission (prior to dosing)
Pregnant or nursing females; sexually active females of childbearing potential who are unwilling or unable to use adequate contraceptive precautions. Female patients to have pregnancy testing are those who are at least 10 years old with menarche and/or thelarche (beginning of breast development)
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