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Clinical Trials/JPRN-jRCTs031210557
JPRN-jRCTs031210557
Recruiting
Phase 2

A single-arm, phase II study to evaluate the effect of low-dose atovaquone on the prevention of pneumocystis pneumonia in patients with rheumatic diseases treated with corticosteroids

Furuta Syunsuke0 sites50 target enrollmentJanuary 18, 2022

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Rheumatic Diseases
Sponsor
Furuta Syunsuke
Enrollment
50
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 18, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Furuta Syunsuke

Eligibility Criteria

Inclusion Criteria

  • Patients who meet all of the following criteria are eligible.
  • 1\) Age 20 years or older (regardless of gender)
  • 2\) Patients who are scheduled to start, or have started within 10 days of starting, prednisolone at a dose of 0\.5 mg/kg/day or higher or equivalent corticosteroids for the treatment of rheumatic diseases.
  • 3\) Patients who have been fully informed about participation in the study prior to the start of the study and who have provided written consent.

Exclusion Criteria

  • Patients who meet any of the following criteria should be excluded.
  • 1\) Patients with a history of continuous use of corticosteroids within 6 months (excluding patients who meet the inclusion criteria 2\)
  • 2\) Patients who are already taking ST combination, atovaquone, pentamidine, or dapsone
  • 3\) Patients with a history of hypersensitivity to atovaquone
  • 4\) Patients with uncontrolled complications
  • 5\) Patients whose AST or ALT exceeds three times the upper limit of the institutional reference value
  • 6\) Patients who are pregnant, may become pregnant, within 28 days postpartum, or breast\-feeding
  • 7\) Any other patient who is judged by the investigator or sub\-investigator to be inappropriate for the safe conduct of the study.

Outcomes

Primary Outcomes

Not specified

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