B-FREE Chronic Babesiosis Study

Phase 2RecruitingNCT06656351

60 Degrees Pharmaceuticals LLC40 enrolled

Overview

Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Babesiosis

Interventions

Tafenoquine 100mgDRUG

Tafenoquine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, aged ≥ 18 years * Severe disabling fatigue * Have at least one common symptom of babesiosis * Have laboratory evidence of exposure to babesia in the last 12 months * Able and willing to give written informed consent * Able and willing to perform all study assessments * If female negative urine pregnancy test and * If female agree to use an acceptable method of birth control Exclusion Criteria: * Glucose-6-phosphate-dehydrogenase (G6PD) deficiency * Breastfeeding * Unmanaged Psychotic disorder * Known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines * Current or planned treatment with quinine * Uncontrolled cardiopulmonary or endocrine disorders * Taking OCT2/MATE substrates without appropriate medical oversight * Medical history of chronic, active viral diseases including HIV/AIDS, hepatitis B, and hepatitis C * Have a risk factors for relapsing babesiosis * Anorexia * Any concomitant significant illness unrelated to babesiosis * The patient is unable to tolerate medication by the oral route * The patient has previously taken tafenoquine * Hemoglobin at baseline is ≤ 8 g/dL

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Change in General Fatigue

The Multidimensional Fatigue Inventory (MFI) is a 20-item, patient-reported scale. designed to evaluate five dimensions of fatigue: general fatigue (items 1, 5, 12, 16), physical fatigue (items (items 2, 8, 14, 20), reduced motivation (items 3, 6, 10, 17), reduced activity (items 4, 9, 15, 18), and mental fatigue (items 7, 11, 13, 19) (Smets-1995). Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). This scale has been used to assess treatment outcomes in patients with chronic fatigue syndrome, women with fibromyalgia, Parkinson's disease, patients undergoing anti-cancer treatment, and the impact of fatigue on the quality of life in rheumatoid arthritis. Total scale score, and each of the 5 subscales scores will be calculated. MFI subscales are scored by summing four items, each has five possible responses giving a range of possible scores from 4 to 20.

Time frame: From enrollment until Day 90 of treatment.

Secondary Outcomes

Babesia nucleic acid test (NAT)

Percentage of patients achieving molecular cure at or earlier than Day 90 who tested positive on the Babesia NAT at baseline, with molecular cure defined as the observance of a negative Babesia NAT test on or before Day 90

Time frame: From baseline until Day 90 of treatment.

Babesia nucleic acid test (NAT)

Proportion of patients with a reactive NAT test at baseline who had a non-reactive NAT test at Day 90

Time frame: From baseline until Day 90 of treatment

Babesia nucleic acid test (NAT) and RT PCR

Number and percentage of patients with a negative Babesia screen on Days 30, 60, 90, 120, and 180 who tested positive at baseline, as assessed individually for each molecular diagnostic test (rtPCR, dPCR, and NAT)

Time frame: From baseline, Days 30, 60, 90, 120, and 180

Central Contacts

Core Research

CONTACT

212-241-7658 CoreResearch@mountsinai.org

Data from ClinicalTrials.gov

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