Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207370
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-12-21
Brief Title:
Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
Sponsor:
60 Degrees Pharmaceuticals LLC
Organization:
60 Degrees Pharmaceuticals LLC
Study Overview
Official Title:
A Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care in Patients Hospitalized for Babesiosis
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a double-blind randomized multisite placebo-controlled trial comparing the safety and efficacy of TQ versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also be administered a standard-of-care antimicrobial regimen AA that is recommended in the 2020 IDSA guideline on the diagnosis and management of babesiosis
Detailed Description:
This study is a double-blind randomized multisite placebo-controlled trial comparing the safety and efficacy of TQ versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also be administered a standard-of-care antimicrobial regimen AA that is recommended in the 2020 IDSA guideline on the diagnosis and management of babesiosis
Patients hospitalized for a diagnosis of babesiosis who have received AA for 48 hours h prior to randomization or are about to receive AA will be asked to provide written informed consent and will undergo eligibility screening including medical history physical examination prior and concomitant medications blood chemistry and hematology glucose-6-phosphate dehydrogenase G6PD deficiency testing blood smear for diagnostic confirmation of babesiosis pregnancy testing for females of child-bearing potential and assessment of risk factors for relapsing babesiosis The screening period will last a maximum of two days The first day of dosing with TQ or placebo will be Day 1 and will be done while the patient is still hospitalized
Patients hospitalized for a diagnosis of babesiosis who have received AA for 48 hours h prior to randomization or are about to receive AA will be asked to provide written informed consent and will undergo eligibility screening including medical history physical examination prior and concomitant medications blood chemistry and hematology glucose-6-phosphate dehydrogenase G6PD deficiency testing blood smear for diagnostic confirmation of babesiosis pregnancy testing for females of child-bearing potential and assessment of risk factors for relapsing babesiosis The screening period will last a maximum of two days The first day of dosing with TQ or placebo will be Day 1 and will be done while the patient is still hospitalized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None