Performance of a Quantitative PCR-Based Assay and Beta-d-Glucan Detection for Diagnosis of Invasive Candidiasis in Very-Low-Birth-Weight Preterm Neonatal Patients (CANDINEO Study)

J Clin Microbiol. 2017 Sep;55(9):2752-2764. doi: 10.1128/JCM.00496-17. Epub 2017 Jun 28.

Abstract

An epidemiological, multicenter, noninterventional, observational case-control study was conducted to describe the performance of serum beta-d-glucan (BDG) and Candida PCR in blood, serum, and sterile samples for the diagnosis of invasive candidiasis (IC) in very-low-birth-weight (VLBW) preterm neonates and to compare these techniques with culture of samples from blood and other sterile sites. Seventeen centers participated in the study, and the number of episodes analyzed was 159. A total of 9 episodes of IC from 9 patients (7 confirmed and 2 probable) and 150 episodes of suspected sepsis from 117 controls were identified. The prevalence of IC was 5.7% (95% confidence interval [95% CI], 2.1 to 9.3). The mortality was significantly higher in episodes of IC (44.4%) than in the non-IC episodes (11.1%, P < 0.01). The sensitivity and specificity of the PCR performed on blood/serum samples were 87.5% and 81.6%, respectively. The sensitivity and specificity of the BDG results were lower (75.0% and 64.6%). For cases with negative culture results, the PCR and the BDG results were positive in 27 (17.4%) and 52 (33.5%) episodes, respectively. The presence of multiorgan failure, improvement with empirical antifungal therapy, thrombocytopenia, and Candida colonization were significantly associated (P < 0.01) with PCR or BDG positivity regardless of the results of the cultures. Serum BDG analysis and Candida PCR could be used as complementary diagnostic techniques to detect IC in VLBW neonates.

Keywords: PCR; invasive candidiasis; polymerase chain reaction; serum beta-d-glucan.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Amphotericin B / therapeutic use
  • Antifungal Agents / therapeutic use
  • Biomarkers / blood
  • Candida / classification
  • Candida / isolation & purification*
  • Candidiasis, Invasive / diagnosis*
  • Candidiasis, Invasive / drug therapy
  • Case-Control Studies
  • Drug Therapy, Combination
  • Echinocandins / therapeutic use
  • Female
  • Fluconazole / therapeutic use
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature*
  • Infant, Very Low Birth Weight*
  • Lipopeptides / therapeutic use
  • Male
  • Micafungin
  • Proteoglycans
  • Real-Time Polymerase Chain Reaction / methods*
  • Sensitivity and Specificity
  • beta-Glucans / blood*

Substances

  • Antifungal Agents
  • Biomarkers
  • Echinocandins
  • Lipopeptides
  • Proteoglycans
  • beta-Glucans
  • liposomal amphotericin B
  • polysaccharide-K
  • Amphotericin B
  • Fluconazole
  • Micafungin