Tzadok, R., Shapira, M.Y., Moses, A.E., Or, R., Block, C., & Strahilevitz, J. (2015). Reduction in incidence of invasive fungal infection in patients receiving allogeneic stem cell transplantation using combined diagnostic-driven approach and itraconazole oral solution. Mycoses, 58, 694–698. 

DOI Link

Study Purpose

To determine the effectiveness of using antifungal therapy in conjunction with the diagnostic driven approach (DDA) in the management of invasive fungal infection (IFI) among patients undergoing allogeneic bone marrow transplantation (BMT)

Intervention Characteristics/Basic Study Process

Two strategies, DDA and antifungal prophylaxis, were used to diagnose and treat early IFI among allogeneic BMT patients. Two segments of 20 months included a preimplementation period in which medical records and laboratory statistics were used from admission up to six months. The intervention was the implementation of a DDA and the provision of antifungal prophylaxis. Prior to implementation, no routine antifungal prophylaxis was administered and the diagnosis of IFI was based on European Organization for Research and Treatment of Cancer (EORTC) criteria, including galactomannan assays. Antifungal agents were administered based on assay results. With the implementation of a new protocol, antifungal prophylaxis was given to those with graft-versus-host disease (GVHD), those treated with corticosteroid therapy, those with severe aplastic anemia, those undergoing cord blood transplantation, and those in which the standard diagnostic workup was deemed to be less effective. All patients were managed in high-efficiency particulate air (HEPA)-filtered rooms and housed in areas with limited access.

Sample Characteristics

  • N = 130   
  • AGE = 35–45 years
  • MALES: 38%, FEMALES: 28%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Malignant and benign, severe aplastic anemia
  • OTHER KEY SAMPLE CHARACTERISTICS: Conditioning regimen (myeloablative or nonmyeloablative), presence of graft-versus-host disease (GVHD), neutropenia phase of absolute neutrophil count [ANC] < 500, and survival rates of three and six months. All had allogeneic hematopoietic stem cell transplantation (HSCT).

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Referral center for HSCT (Hadassah Medical Center), Israel

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care

Study Design

  • Pre-post design in which two periods pre intervention and post intervention segments were analyzed

Measurement Instruments/Methods

  • Breakthrough IFI (not specifically defined)
  • Antifungal use
  • Diagnostic test utilization

Results

A significant reduction in the cases of IFI (p = 0.051) was observed overall. The incidence of mold infection (aspergillosis) decreased substantially in the protocol period (p = 0.054). However, no change was noted in the survival rates and breakthrough fungal infection in the pre and post intervention phases.

Conclusions

The implementation of a clinical management protocol helped diagnose and treat early fungal infection and was associated with an overall reduction in the incidence of IFI.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • Drug toxicity level and poor oral acceptability of the medication
  • No differentiation between individuals who received antifungals prior to the protocol period in comparing outcomes
  • Comparison to a historical cohort with potential related threats to validity

Nursing Implications

Nursing role is vital in identifying the key sign and symptoms of infection and to highlight them to decrease the rates of fungal infections, hence minimizing the mortality and morbidity rates overall. This study demonstrated that a standardized approach to prophylaxis was associated with reduced fungal infections.