Wang, C.H., Kan, L.P., Lin, H.A., Chang, F.Y., Wang, N.C., Lin, T.Y., . . . Lin, J.C. (2016). Clinical efficacy and safety of primary antifungal prophylaxis with posaconazole versus fluconazole in allogeneic blood hematopoietic stem cell transplantation recipients: A retrospective analysis of a single medical center in Taiwan. Journal of Microbiology, Immunology, and Infection, 49, 531–538.

DOI Link

Study Purpose

To determine the safety and efficacy of posaconazole versus fluconazole as antifungal prophylaxis in patients receiving allo-HSCT during early neutropenic phase without GVHD

Intervention Characteristics/Basic Study Process

Medical records were retrospectively reviewed for allo-HSCT recipients from a single institution, who received oral fluconazole (January 2005 to June 2011) or oral posaconazole (June 2011 to December 2013) during the early neutropenic stage.

Sample Characteristics

  • N = 52   
  • AGE: 2 younger than age 18 years; all others varied
  • MALES: Not diversified  
  • FEMALES: Not diversified
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Allo-HSCT
  • OTHER KEY SAMPLE CHARACTERISTICS: Fluconazole, posaconazole, prophylaxis, transplantation, GVHD

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

All patients who received allo-HSCT in the HSCT-dedicated room and were given prophylactic oral posaconazole (June  2011 to December 2013) or fluconazole (January 2005 to June 2011) were included. Exclusions were active infections, secondary fungal infections, or given an agent other than the two stated. Observation began seven days prior to transplantation and continued 90 days after transplantation.

Measurement Instruments/Methods

Suspected invasive fungal infection was characterized as unexplained persistent fever that lasted 72-96 hours despite empiric broad spectrum antibiotics. Clinical and laboratory values were collected at baseline and throughout the study. ALT, AST, and total bilirubin were collected for hepatic toxicity. Incidence of neutropenic fever and overall mortality at 90 days post-transplantation was assessed.

Results

Fluconazole had a greater risk for development of invasive fungal infections during the 90 days (42.5% versus 8.3%, p = 0.039) even at higher doses of fluconazole. Both groups had similar rates of neutropenic fevers (83.3% versus 87.5%, p = 0.656) and mortality (8.3% versus 22.5%, p = 0.04).  Early discontinuation due to intolerance was lower in posaconazole than fluconazole (8.3% versus 50.0%, p = 0.017). Both had similar rates of GI upset, but fluconazole patients were more likely to have diarrhea. No patient discontinued either drug due to liver impairment, although both groups saw equally elevated laboratory values that normalized after discontinuation except for four patients (n = 1 posaconazole and n = 3 fluconazole).

Conclusions

Results concluded that implementing a prophylaxis regimen with posaconazole for preventing invasive fungal infections in allo-HSCT patients during the early neutropenic phase through 90 days post-transplantation was better tolerated with better efficacy and similar safety concerns when compared to fluconazole.

Limitations

Small sample (< 100)

 

Nursing Implications

Nurses could incorporate evidence-based practices of hand hygiene, isolation, low microbial diets, teaching, and reinforcement plans for these fragile patients to work synonymously with the prophylaxis antifungal.