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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031210557

Enrollment

Registered

2022-01-18

Start date

2022-03-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Diseases

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Incidence rate of Pneumocystis pneumonia in the first six months of the study	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactSyunsuke Furuta

Chiba University Hospital

shfuruta@chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026