Optimal regimens of sulfamethoxazole-trimethoprim for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases: multi-center randomized open label trial

Optimal regimens of sulfamethoxazole-trimethoprim for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases: multi-center randomized open label trial - Optimal regimens of Baktar for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031513

Enrollment

300

Registered

2018-03-01

Start date

2018-04-01

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

Pneumocystis pneumonia

Interventions

SMX/TMP of daily 400 mg/80 mg for 52 weeks. SMX/TMP of daily 200 mg/40 mg for 52 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women aged over 20 years 2. Being admitted to our hospitals for diagnosis and/or treatment of new-onset or relapsed systemic rheumatic diseases from 1st April 2018 to 31st March 2021. 3. Have received 0.6 mg/kg/day or more of oral prednisolone or equivalent doses of corticosteroids with or without any immunosuppressant 4. Have not used SMX/TMP, pentamidine isethionate, dapsone, or atovaquone previously 5. Have serum creatinine level within the normal range of the institution. 6. Able and willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Have contraindications to SMX/TMP 2. Have a history of PCP 3. Have received biologic agents 4. Have uncontrollable complications 5. Body weight below 40 kg 6. Being pregnant or a nursing woman 7. Being unable to start SMX/TMP within 14 days of starting prednisolone 8. Unable to give informed consent

Design outcomes

Primary

Measure	Time frame
The primary endpoint was non-incidence rate of PCP at week 52.	—

Secondary

Measure	Time frame
The secondary endpoint was drug continuation rate at week 52.	—

Countries

Japan

Contacts

Public ContactYoshiyuki Abe

Juntendo University School of Medicine Department of Internal Medicine and Rheumatology

yo-abe@juntendo.ac.jp0338133111

Outcome results

None listed

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