B-FREE Chronic Babesiosis Study | Clinical Trial

Key information

Conditions

Chronic Babesiosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

David Putrino

CONTACT

David Putrino, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tafenoquine 100mg

Drug

Tafenoquine

Primary outcomes

Change in General Fatigue

Time frame: From enrollment until Day 90 of treatment.

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.

Secondary outcomes

Babesia nucleic acid test (NAT)

Time frame: From baseline until Day 90 of treatment.

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
Babesia nucleic acid test (NAT)

Time frame: From baseline until Day 90 of treatment

Proportion of patients with a reactive NAT test at baseline who had a non-reactive NAT test at Day 90
Babesia nucleic acid test (NAT) and RT PCR

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

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Core Research

CONTACT

[email protected]

212-241-7658

Sponsors and collaborators

Lead sponsor

60 Degrees Pharmaceuticals LLC

Industry

Registry information

Official study title

B-FREE Chronic Babesiosis Study: A Phase 2 Open Label Study of Tafenoquine for Treatment of Chronic Babesiosis Patients With Severe Fatigue

Acronym: TQ-BA-2024-3

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Oct 24, 2024
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.