Antifungal Services

Antimicrobial Activity in Vitro

• Antifungal susceptibility testing (AST) CLSI and EUCAST based:

• • Minimum inhibitory concentration (MIC)

  • Minimum fungicidal concentration (MFC)

  • Minimum effective concentration (MEC)

• Testing of drug combinations
• Time-kill assay (microbial kill curves)
• Post-antimicrobial effect (PAE)
• Nail penetration assay including lacquer effect on drug penetration
• Keratin binding assay
• Biofilms prevention and treatment assays

In Vivo Testing (Small Animals)

• Immunocompetent and immunosuppressed models:
  • Mice:
    Invasive candidiasis, Invasive mould infections (aspergillosis, fusariosis, mucormycosis), Mucosal (oral and vaginal) candidiasis, Wound infection model, Subcutaneous device-associated microbial biofilms, Keratitis (Fusarium, Candida, bacterial)

• • Guinea Pig:
    Onychomycosis (topical and oral dosing), Invasive and cutaneous candidiasis

• • Rabbit:
    Invasive candidiasis, Biofilms-associated infections

Mechanism of Action (MOA)

• Effect on microbial ultrastructure/morphology/architecture
• Inhibition of cell wall synthesis/cell wall damange
• Lysis of cell membrane
• Protein synthesis
• Inhibition of DNA or RNA replication
• Assessment of potential to develop resistance

Clinical trial support

• Central lab for single and multi-site clinical trials both national and international

• Assist in selection of optimal clinical sites

• Implementation of clinical protocols

  • Protocol-related training, Fungal isolate storage, Close interactions with site Principle Investigators (PI) and staff, Data integrity maintained in collaboration with other CROs

Assays Performed

• KOH/Fluorescent (Calcoflour) direct smear

  • Results sent within 24 hours

• Culture and identification of fungi

  • Specimen-collection kits provided, Shipping material provided compliant with the International Air Transport Association (IATA)

• Antifungal susceptibility testing

  • Baseline and end-of-study isolates that allows monitoring of resistance development

Data Management

• Comply with information technology rules/regulations

• All data are firewall and password protected

• Data stored in 21 CFR part 11-compliant database

• Redundant data backup procedures in place

Regulatory Services

• Provides assistance with research design and regulatory compliance in accordance with IRB and Federal requirements