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Lay Description

A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.

Category

  • Immune System
  • Infections / Infectious Diseases
IRB Number
20190187HU
NCT Number
NCT03583164
Open to Enrollment
Yes

Eligibility

Eligible Ages
Over 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male and female aged at least 18 years, or male and female aged 16 years or 17 years and who weigh at least 40 kg whom have given informed consent
  • Ability and willingness to comply with the protocol.
  • Able to take oral medication
  • Female must be non-lactating and at no risk of pregnancy
  • Male with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception
  • Patients with invasive fungal disease
  • Patients who have limited alternative treatment options

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
  • Patients with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis.
  • HIV infection but not currently receiving antiretroviral therapy.
  • Patients with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the patient
  • Previously enrolled patients or patients enrolled in any clinical trial within the last 30 days
  • Patients receiving treatment limited to supportive care due to predicted short survival time.
  • Prohibited concomitant medications.
  • Any exclusion criteria required by local regulatory authorities.

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Omar Catano
(210) 567-1981
catano@uthscsa.edu

Regulatory Point of Contact
Thomas Patterson
(210) 567-4666
patterson@uthscsa.edu

Regulatory Point of Contact
Robin Tragus
(210) 567-5262
tragus@uthscsa.edu

Local Recruitment Point of Contact
Omar Catano
(210) 567-1981
catano@uthscsa.edu

Local Recruitment Point of Contact
Robin Tragus
(210) 567-5262
tragus@uthscsa.edu

Principal Investigator
Thomas Patterson