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The use of prophylactic fluconazole in very low birth weight infants

The use of prophylactic fluconazole in very low birth weight infants. Martin Skidmore University of Toronto. Incidence and burden of fungal infections in the NICU. Candida spp third most common cause of late onset sepsis (>72 h) in VLBW (<1500g)

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The use of prophylactic fluconazole in very low birth weight infants

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  1. The use of prophylactic fluconazole in very low birth weight infants Martin Skidmore University of Toronto

  2. Incidence and burden of fungal infections in the NICU • Candida spp third most common cause of late onset sepsis (>72 h) in VLBW (<1500g) • 75% of infected VLBW infants will die or survive with handicap • Overall mortality rates estimated at 10-15% • Case mortality rates as high as 44% • In Canada (2003-2005): incidence 6.7% infants <28 weeks* • *CNN unpublished

  3. Rationale for antifungal prophylaxis • Associated with: • Endocarditis 15.3% • Meningitis 8.4% • Intra-abdominal involvement 8% • Eye involvement 6% • 50% continue to have positive cultures in spite of therapy • 10% culture positive > 14 days

  4. Risk factors for candidiasis • ELBW • Low gestational age • Therapies • Intubation • Ventilation • Central line placement • TPN • Medications • Steroids • H2 blockers • antibiotics

  5. Strategies • Optimal infection control practices • Avoid broad spectrum antibiotic coverage • Prompt removal of infected devices • Prevention of colonization 30% of NICUs use some form of antifungal prophylaxis* • Fluconazole • Topical nystatin • Amphoteracin B *AAP/Neo-Peri Section questionnaire

  6. Why fluconazole? • Has a long half-life • Well concentrated in tissues and body fluids • Low lipophilicity • Low protein binding • 80% excreted unchanged in the urine • Persistence of high skin and mucosal concentrations • 70-90% penetration into CSF • Concentrated in urine and CSF However: • Elevations in liver enzymes (reversible) • Elevations in serum bilirubin (reversible)

  7. RCTs of oral antifungal agents* *adapted from Healy,M: NeoReviews, 2008

  8. RCTs of fluconazole prophylaxis in neonates

  9. Safety of fluconazole • Has minimal toxicity (LFTs) • No increase in late onset bacterial infection • No increase in NEC • No development of antifungal agent resistance • ?Increase in frequency of C.glabrata and C.parapsilosis • In P/Ts: decrease dose, duration of exposure, longer dosaging intervals • No longterm N/D outcome data to date

  10. Optimal dosing and schedule • Trials: • 3-6 mg/kg • 24-72 h intervals • 7 different schedules • Kaufman: • 3mg/kg PO starting on Day 1 or 2 • Twice per week • For up to 6 weeks

  11. Who should receive fluconazole prophylaxis? • BW ≤ 750 gm • GA ≤27 weeks • IF BASELINE FUNGAL INFECTION RATES ARE HIGH (eg: >5%) • Why not ≤ 1500 gm BWs?

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