High negative predictive value diagnostic strategies for the reevaluation of early antifungal treatment: A multicenter prospective trial in patients at risk for invasive fungal infections

J Infect. 2015 Aug;71(2):258-65. doi: 10.1016/j.jinf.2015.04.005. Epub 2015 Apr 18.

Abstract

Early antifungal therapeutic strategies are proposed during invasive fungal infection (IFI), but antifungal stewardship programs should institute a systematic reevaluation of prescriptions, particularly in the context of empirical treatment. Here, we aimed to evaluate the performances and particularly the negative predictive value (NPV) of diagnostic strategies, including a whole blood panfungal quantitative PCR assay (PF-qPCR) in a high risk population for IFI. The first step was to standardize and optimize a new PF-qPCR targeting ITS2 region. Then, this method was evaluated in a multicenter prospective study including 313 patients with suspected IFI for whom an early antifungal treatment was prescribed. All patients enrolled at day 0 of their treatment benefited from serum Aspergillus galactomannan (GM) antigen detection twice a week, weekly PF-qPCR assay, and when indicated and feasible, CT-scan and mycological sampling. In total, 125 of 313 patients were diagnosed with IFI: 68 invasive aspergillosis (eight proven, 48 probable and 12 possible), one fusariosis, 47 candidemia, three disseminated candidiasis and six cryptococcosis. Globally, the sensitivity of the PF-qPCR assay was only 40%, but the specificity, PPV and NPV were 96%, 88% and 69%, respectively. In the population of patients at high risk for invasive aspergillosis who also benefited from Aspergillus GM detection, the sensitivity and the NPV of the combined detection reached to 78% and 84%, respectively. Even higher NPV were obtained when combining negative PF-qPCR and CT scan (95%) as well as negative GM and CT scan (93%), thus allowing to rationalize and re-evaluate the prescription of empirical treatment in such highly selected population.

Keywords: Antifungal stewardship program; Antifungals; Aspergillus galactomannan; Empirical treatment; Invasive aspergillosis; Invasive fungal infection; PCR; Panfungal PCR; Reevaluation.

Publication types

  • Evaluation Study
  • Multicenter Study

MeSH terms

  • Adult
  • Blood / microbiology*
  • DNA, Fungal / genetics
  • DNA, Fungal / isolation & purification
  • DNA, Ribosomal Spacer / genetics
  • DNA, Ribosomal Spacer / isolation & purification
  • Drug Monitoring / methods*
  • Female
  • Fungemia / diagnosis*
  • Fungemia / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Molecular Diagnostic Techniques / methods*
  • Predictive Value of Tests
  • Prospective Studies
  • Real-Time Polymerase Chain Reaction / methods*
  • Secondary Prevention / methods*
  • Treatment Outcome
  • Young Adult

Substances

  • DNA, Fungal
  • DNA, Ribosomal Spacer