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Tests treatment safety and results for Invasive Fungal Infection
Official title Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection
ClinicalTrials.gov ID: NCT06678113
What this study is testing
What is BSG005?
BSG005 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for invasive fungal infection.
Also referred to as Polyene Macrolide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is an open-label, Phase 1b, dose-escalation/finding study to assess the safety and efficacy of intravenous BSG005 in patients with uncomplicated invasive fungal infections (IFI). Approximately 15 patients are planned to be enrolled in 3 cohorts.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Age 18 years.
- Able to provide written informed consent or have a legally authorized representative that can provide informed consent in case of incapacitation.
- Diagnosed by Investigator to have an IFI. \- Proven IFIs as defined in the 2020 consensus definitions by the European Organization for Research and...
- IFI patients with mild to moderate renal impairment or IFI patients requiring an alternative treatment as current treatment cannot be continued due...
- Failure with one first-line agent, defined as either: Radiologic progression, Increase in serologic markers such as galactomannan antigen or...
You likely can't join if
- Patient has a known hypersensitivity or severe infusion-related reaction to any polyene drug.
- Infection caused by a known or suspected organism with intrinsic resistance to AmB.
- Concurrent use of another investigational agent within 30 days of enrollment.
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 30 mL/min or dialysis. Patients with acute kidney injury with eGFR...
- Has liver enzyme results (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) greater than 5 times the upper limit of normal. Note...
- Has a bilirubin level greater than 5 times the upper limit of normal. Note: Patients may be rescreened within 48 hours if laboratory values are found...
See the full eligibility criteria
- Age 18 years.
- Able to provide written informed consent or have a legally authorized representative that can provide informed consent in case of incapacitation.
- Diagnosed by Investigator to have an IFI. \- Proven IFIs as defined in the 2020 consensus definitions by the European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research...
- IFI patients with mild to moderate renal impairment or IFI patients requiring an alternative treatment as current treatment cannot be continued due to any of the following
- Failure with one first-line agent, defined as either: Radiologic progression, Increase in serologic markers such as galactomannan antigen or beta-D-glucan, Failure of clearance of cultures , Progression or lack of...
- Inability to tolerate AmB, as defined by at least one of the following: Nephrotoxicity with either: 1.5 mg/dL increase in creatinine from baseline, 50% increase in creatinine from baseline ii. Contraindication to use...
- Documented in vitro resistance to first-line antifungal therapy (ie fluconazole resistance in Candida auris)
- Treatment-limiting drug-drug interactions prohibiting the use of antifungals (azoles and echinocandins) such as concurrent rifampcin, rifabutin, phenytoin, carbamazepine, bedaqualine
- Patient has a known hypersensitivity or severe infusion-related reaction to any polyene drug.
- Infection caused by a known or suspected organism with intrinsic resistance to AmB.
- Concurrent use of another investigational agent within 30 days of enrollment.
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 30 mL/min or dialysis. Patients with acute kidney injury with eGFR less than 30 mL/min and improving creatinine level can be included as...
- Has liver enzyme results (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) greater than 5 times the upper limit of normal. Note: Patients may be rescreened within 48 hours if laboratory values are found...
- Has a bilirubin level greater than 5 times the upper limit of normal. Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
- Patients who have an ejection fraction less than 25% of predicted.
- Currently pregnant or planning on getting pregnant while on study (details of contraception guidance are provided in Section 13).
- Breastfeeding.
- Patients not likely to survive a minimum of 28 days from start of screening.
- Patient receiving prohibited medications.
- Patient is an abuser of alcohol or medication. \-
The study team makes the final eligibility decision.
Where it's taking place
- Dehli, Haryana, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dehli, Haryana, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.