Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis

Conditions

• Babesiosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tafenoquine — DRUG
  Oral Tafenoquine
• Placebo — OTHER
  Placebo

Study Details

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.

Key Dates

Start date

Jun 17, 2024

Status verified

Nov 2025

Primary completion

Mar 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

33 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Active Comparator: Group 1
  TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4
• Placebo Comparator: Group 2
  Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4

Primary Outcome Measure

Time to sustained clinical resolution [ Time Frame: Day 1 to 90 ]

Central Contacts

• Geoff Dow
  202-327-5422
  [email protected]

Locations (1)

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