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NCT06207370 · ClinicalTrials.gov registry record · Phase 2
Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
A Phase 2 study of Babesiosis, sponsored by 60 Degrees Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT06207370: Recruiting Phase 2 study of Babesiosis, sponsored by 60 Degrees Pharmaceuticals.
NCT06207370 is a Phase 2 study of Babesiosis that is actively recruiting participants, run by 60 Degrees Pharmaceuticals. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06207370, a Phase 2 study of Babesiosis, is actively recruiting participants, sponsored by 60 Degrees Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Tafenoquine
Study Locations (1)
Massachusetts
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2024-06-17 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 2 |
What NCT06207370 shows while recruiting
NCT06207370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Babesiosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06207370 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06207370 about?
NCT06207370 is a clinical study titled "Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care 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 recomm...
What is the current status of trial NCT06207370?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2024-06-17. Estimated completion is 2027-07-01.
What conditions does trial NCT06207370 study?
This clinical trial studies the following conditions: Babesiosis.
What interventions are being tested in trial NCT06207370?
The interventions under investigation include: Placebo (OTHER), Tafenoquine (DRUG).
Who is sponsoring clinical trial NCT06207370?
This trial is sponsored by 60 Degrees Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06207370 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06207370's enrollment target sits among peer trials
33 1553rd of 2000 higher than 439 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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