Babesiosis
Conditions
Keywords
babesiosis
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.
Interventions
DRUGTafenoquine
Oral Tafenoquine
OTHERPlacebo
Placebo
Sponsors
60 Degrees Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to sustained clinical resolution | Day 1 to 90 | Time to sustained clinical resolution of all the following symptoms of babesiosis: sweats, joint aches, cough, loss of appetite, muscle aches, headache, chills or shivering, feeling hot or feverish, nausea, fatigue (low energy or tiredness), and vomiting. The time to achieve sustained clinical resolution will be the date when patients first self-report a 7-day period without these symptoms relative to the start of tafenoquine or placebo treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in TTMC between TQ and placebo | Day 1 to 90 | Difference in TTMC between TQ and placebo from Day 1 to Day 90 (± 7 days). Molecular cure is defined as the time to the first instance of a negative NAT. |
Countries
United States
Contacts
Primary ContactGeoff Dow
Outcome results
None listed