Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, … (NCT02814916) | Clinical Trial Compass
CompletedPhase 3
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
United States199 participantsStarted 2017-03-30
Plain-language 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.
Who can participate
Age range0 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Hypothermia (\<36°C) OR fever (\>38.5°C)
✓. 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
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.
What they're measuring
1
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Timeframe: Baseline, Day 28 (± 2 days)
2
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Timeframe: Baseline, Day 28 (± 2 days)
3
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Timeframe: Baseline, Day 28 (± 2 days)
4
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Timeframe: Baseline, Day 28 (± 2 days)
5
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
✕. 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.