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Twice-weekly fluconazole prophylaxis in premature infants: association with cholestasis
Vishwanath Bhat1, Milliecor Fojas, Judy G Saslow
1Pediatrics/Neonatology, Cooper University Hospital-Robert Wood Johnson Medical School, Camden, New Jersey 08103, USA.
Insights
Less frequent dosing (LFD) fluconazole prophylaxis effectively prevents invasive fungal infections in extremely low-birthweight infants. This LFD schedule also reduced the severity of cholestasis, a known side effect of fluconazole.
Area of Science:
- Neonatalogy
- Pediatric Infectious Diseases
- Clinical Pharmacology
Background:
- Fluconazole prophylaxis is established for preventing invasive candidiasis in extremely low-birthweight (ELBW) infants.
- Previous findings indicated an increased incidence of cholestasis with standard fluconazole dosing in ELBW infants.
- This led to the adoption of a less frequent dosing (LFD) schedule (twice weekly) at the institution.
Purpose of the Study:
- To evaluate the effectiveness of the LFD fluconazole regimen in preventing invasive candidiasis in ELBW infants.
- To assess the safety profile of the LFD fluconazole regimen, specifically regarding the incidence and severity of cholestasis.
Main Methods:
- A comparative study design was employed, comparing ELBW infants on the LFD fluconazole regimen (twice weekly for up to 6 weeks) with those on a frequent dosing (FD) schedule.
- Infants were analyzed for baseline demographics, risk factors for candidiasis, rates of invasive fungal infection, and incidence/severity of cholestasis.
Main Results:
- No significant difference was found in the incidence of invasive candidiasis between the LFD (2%) and FD (0%) groups (P=0.4).
- The LFD schedule demonstrated a trend towards decreased incidence of cholestasis.
- A notable reduction in the severity of cholestasis was observed in infants receiving the LFD regimen.
Conclusions:
- The LFD fluconazole prophylaxis regimen is effective in preventing invasive fungal infections in ELBW infants.
- The LFD schedule is associated with decreased severity of cholestasis compared to the FD schedule.
- This LFD regimen offers a potentially safer alternative for fungal infection prophylaxis in this vulnerable population.
Background:
Fluconazole prophylaxis is effective in preventing invasive candidiasis in extremely low-birthweight (ELBW) infants. The authors previously reported an increased incidence of cholestasis with fluconazole prophylaxis in ELBW infants, which led to fluconazole prophylaxis being changed to a less frequent dosing (LFD) schedule of twice a week at their institution. The purpose of the present study was therefore to evaluate the effectiveness and safety of LFD fluconazole prophylaxis in preventing invasive candidiasis in ELBW infants.
Methods:
ELBW infants who received the LFD regimen of fluconazole (twice a week for up to 6 weeks) were compared with infants who received the frequent dosing (FD) schedule (every 72 h for first 2 weeks, every 48 h for next 2 weeks and every 24 h for the final 2 weeks). The two groups were compared for baseline demographics, risk factors for candidiasis, the rate of invasive fungal infection and the incidence and severity of cholestasis.
Results:
There was no significant difference in the incidence of invasive candidiasis in infants who received the LFD (2/104, 2%) compared to FD (0/140, 0%; P= 0.4) fluconazole prophylaxis. The severity of cholestasis was lower and a trend towards decreased incidence of cholestasis was observed on the LFD schedule.
Conclusion:
The LFD regimen of fluconazole prophylaxis is effective in preventing invasive fungal infection in ELBW infants. The severity of cholestasis was decreased with the LFD schedule.
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