A clinical trial to evaluate the effect of low-dose atovaquone on the prevention of pneumocystis pneumonia in patients with rheumatic diseases
- Conditions
- Rheumatic Diseases
- Registration Number
- JPRN-jRCTs031210557
- Lead Sponsor
- Furuta Syunsuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of Pneumocystis pneumonia in the first six months of the study
- Secondary Outcome Measures
Name Time Method Secondary endpoints of efficacy<br>1. Percentage of patients who were able to take Atovaquone during the period when it was indicated<br>2. Proportion of days that Atovaquone was actually taken during the period for which it was indicated<br>3. The total amount of corticosteroids (prednisolone equivalent) used during the study period<br>4. Other immunosuppressive agents and biologics used during the study period<br><br>Secondary endpoints of safety<br>Incidence of adverse events<br><br>Exploratory endpoints <br>1. Changes in lymphocyte count during the study period (0, 1, 3, 6 1+-7 days)<br>2. reasons for discontinuation of Atovaquone