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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

A clinical trial to evaluate the effect of low-dose atovaquone on the prevention of pneumocystis pneumonia in patients with rheumatic diseases

Furuta Syunsuke

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, JAPAN

shfuruta@chiba-u.jp

Furuta Syunsuke

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, JAPAN

+81-43-222-7171

shfuruta@chiba-u.jp

Recruiting

Jan. 18, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

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.

Both

Rheumatic Diseases

In patients treated with corticosteroids, oral atovaquone should be started within 10 days of the start of treatment.
- The dosage of atovaquone is 5 mL (750 mg of atovaquone) per package of SAMTILER Content Suspension 15%, once a day.
- If the dose of corticosteroids is reduced to less than 5 mg/day of prednisolone equivalent, atovaquone should be discontinued until the day before the reduction. In cases where the prescription of atovaquone was terminated for this reason, atovaquone should be resumed from the day of dose increase only when the dose of corticosteroid is increased again to 0.5 mg/kg/day or more in terms of prednisolone for the purpose of treatment related to the primary disease such as relapse of the primary disease.
- Patients who do not meet the above criteria should take atovaquone for 6 months, unless they meet the discontinuation criteria.

Incidence rate of Pneumocystis pneumonia in the first six months of the study

Secondary endpoints of efficacy
1. Percentage of patients who were able to take Atovaquone during the period when it was indicated
2. Proportion of days that Atovaquone was actually taken during the period for which it was indicated
3. The total amount of corticosteroids (prednisolone equivalent) used during the study period
4. Other immunosuppressive agents and biologics used during the study period

Secondary endpoints of safety
Incidence of adverse events

Exploratory endpoints
1. Changes in lymphocyte count during the study period (0, 1, 3, 6 1+-7 days)
2. reasons for discontinuation of Atovaquone

+81-43-226-2616

Jan. 11, 2022

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