Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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29 January 2024 |
Main ID: |
NCT02814916 |
Date of registration:
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08/06/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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March 31, 2017 |
Target sample size:
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199 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT02814916 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Belarus
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Bulgaria
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Chile
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Colombia
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Georgia
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Greece
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Guatemala
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Latvia
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Lithuania
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Mexico
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Panama
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Poland
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Romania
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Russian Federation
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South Africa
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Spain
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Ukraine
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United States
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Contacts
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Name:
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ABBVIE INC. |
Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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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
- In patients age birth to < 3 months, each patient must meet the following
inclusion criteria to be enrolled in this study.
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
Suspected or confirmed sepsis including any of the following clinical
criteria:
1. Hypothermia (<36°C) OR fever (>38.5°C)
2. Bradycardia OR tachycardia OR rhythm instability
3. Hypotension OR mottled skin OR impaired peripheral perfusion
4. Petechial rash
5. New onset or worsening of apnea episodes OR tachypnea episodes OR
increased oxygen requirements OR requirement for ventilation support
6. Feeding intolerance OR poor sucking OR abdominal distension
7. Irritability
8. Lethargy
9. Hypotonia
3. In addition, patients must meet at least one of the following laboratory
criteria:
a. White blood cell count =4.0 × 10^9/L OR =20.0 × 10^9/L b, Immature to
total neutrophil ratio >0.2 c. Platelet count =100 × 10^9/L d. C-reactive
protein (CRP) >15 mg/L OR procalcitonin = 2 ng/mL e. Hyperglycemia OR
Hypoglycemia f. Metabolic acidosis
4. Infections must be of sufficient severity to merit hospitalization and
parenteral antibiotic therapy. These infections may include:
1. Cutaneous or subcutaneous abscess
2. Surgical site or traumatic wound infection
3. Cellulitis, Erysipelas
4. Omphalitis
5. Impetigo and bullous impetigo
6. Pustular folliculitis
7. Scarlet fever
8. Staphylococcal scalded skin syndrome
9. Streptococcal toxic shock syndrome
10. Erythematous based-erosion
11. Other infections originating in the skin or subcutaneous tissue and
associated with signs and symptoms of sepsis as defined in Inclusion
Criterion 2.
5. Patients must be expected to survive with appropriate antibiotic therapy and
appropriate supportive care throughout the study.
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
Age minimum:
0 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Staphylococcal Skin Infections
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Bacterial Infections
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Methicillin-Resistant Staphylococcus Aureus
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Intervention(s)
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Drug: Comparator
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Drug: Dalbavancin two dose
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Drug: Dalbavancin single dose
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Primary Outcome(s)
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Number of patients with abnormal audiologic assessment
[Time Frame: Baseline to Day 28 (± 2 days)]]
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Change in number of patients with the presence of either Clostridium difficile (CD), vancomycin-resistant enterococci (VRE), or both CD and VRE in bowel flora
[Time Frame: Baseline to Day 28 (± 2 days)]
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Secondary Outcome(s)
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Clinical response evaluated at follow-up visit: Cure
[Time Frame: Baseline and Day 54 (± 7 days)]
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Clinical response evaluated at the end of treatment (EOT) visit: Failure
[Time Frame: Baseline and Day 14 (± 2 Days)]
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Clinical response
[Time Frame: Baseline to 48 - 72 hours]
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Clinical response evaluated at follow-up visit: Failure
[Time Frame: Baseline and Day 54 (± 7 days)]
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Clinical response evaluated at the test of cure (TOC) visit: Unknown
[Time Frame: Baseline and Day 28 (± 2 Days)]
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Clinical response evaluated at the end of treatment (EOT) visit: Improvement
[Time Frame: Baseline and Day 14 (± 2 Days)]
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Clinical response evaluated at the end of treatment (EOT) visit: Unknown
[Time Frame: Baseline and Day 14 (± 2 Days)]
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Clinical response evaluated at follow-up visit: Unknown
[Time Frame: Baseline and Day 54 (± 7 days)]
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Clinical response evaluated at the end of treatment (EOT) visit: Cure
[Time Frame: Baseline and Day 14 (± 2 Days)]
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Clinical response evaluated at the test of cure (TOC) visit: Cure
[Time Frame: Baseline and Day 28 (± 2 Days)]
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Dalbavancin plasma concentration
[Time Frame: Within 14 (± 2) days of study drug administration]
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All-cause mortality: For patients age birth to < 3 months, all-cause mortality will be determined at test of cure (TOC) visit
[Time Frame: Baseline and Day 28 (± 2 days)]
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Clinical response evaluated at the test of cure (TOC) visit: Failure
[Time Frame: Baseline and Day 28 (± 2 Days)]
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Presence of baseline pathogen after treatment
[Time Frame: Baseline to Day 54 (± 7 days)]
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Secondary ID(s)
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DUR001-306
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2014-005281-30
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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