Clinical trial NCT06207370: Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Babesiosis
Keywords: babesiosis
Lead sponsor: 60 Degrees Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (A/A) 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 (A/A) 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 A/A for \<48 hours (h) prior to randomization or are about to receive A/A, 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.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged ≥ 18 years.
* Laboratory confirmed infection with Babesia.
* Exhibiting at least one self-reported clinical symptoms of babesiosis.
* Able and willing to give written informed consent.
* Expected to be hospitalized at the time of or following informed consent and still hospitalized on the day of randomization and start of investigational products.
* Willing to complete the study activities and assessments.
* Must agree not to enroll in another study of an investigational agent prior to completion of the study.
* Able to take oral medications.
* If female of reproductive age, must agree to use an acceptable method of birth control.
* Adequate venous access.
* Blood hemoglobin ≥ 7 g/dL.

Exclusion Criteria:

* Have any contraindications to TQ.
* Have any contraindication for azithromycin or atovaquone.
* Any concomitant significant illness unrelated to babesiosis.
* Receipt of any experimental treatment for babesiosis.
* Taking any excluded concomitant medication.
* Current or planned treatment with quinine while participating in the study.
* Positive pregnancy test.
* If A/A was initiated more than 48h prior to randomization and parasitemia is not \>1%.
* Azithromycin or atovaquone administered in the last 12 months to treat babesiosis, and, in the opinion of the investigator, high likelihood that current infection represents a relapse or continuation of disease.

Primary outcomes:
measure: Time to sustained clinical resolution
timeFrame: Day 1 to 90
Secondary outcomes:
measure: Difference in TTMC between TQ and placebo
timeFrame: Day 1 to 90
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References: