BabesiosisPhase 2NCT06207370
Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
A Phase 2 study testing Tafenoquine in people with Babesiosis, run by 60 Degrees Pharmaceuticals LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Babesiosis
- What is being tested?
- Tafenoquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Lauren Tobias, Lauren.E.Tobias@tuftsmedicine.org
Whitney Perry, MD
About this study
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
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.
Read the 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.
- Conditions
- Babesiosis
- Being tested
- Tafenoquine, Placebo
- Keywords
- babesiosis
- Medical subject headings
- Babesiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafenoquineDrug
Oral Tafenoquine
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4 Receives: Drug: Tafenoquine |
| Group 2 | Placebo comparator | Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sustained clinical resolution
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.
Measured: Day 1 to 90
Secondary outcomes (1)
Difference in TTMC between TQ and placebo
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.
Measured: Day 1 to 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start17 Jun 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BabesiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 60 Degrees Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207370
- Sponsor's protocol ID
- TQ-BA-2024-1
- Status last verified
- Nov 2025
- First submitted
- 21 Dec 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06207370
- Acronym / sponsor ID
- TQ-BA-2024-1
- Conditions
- Babesiosis
- Keywords
- babesiosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- 60 Degrees Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: TafenoquineTQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4 |
| Group 2 | Placebo comparator | Other: PlaceboPlacebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TafenoquineOral Tafenoquine | Drug | Group 1 |
| PlaceboPlacebo | Other | Group 2 |
Primary outcome
Time to sustained clinical resolution
Time frame: 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.
1 secondary outcome
Difference in TTMC between TQ and placebo
Time frame: Day 1 to 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tafenoquine in people with Babesiosis, run by 60 Degrees Pharmaceuticals LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geoff Dow (202-327-5422, geoffdow@60degreespharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sustained clinical resolution (time frame: Day 1 to 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.