Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options
A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
16 Years and up
Accepting Healthy Volunteers?
- 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
- 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.
- Invasive Fungal Infections