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Prospective study evaluating the efficacy and safety of low-dose trimethoprim-sulfamethoxazole for prevention of Pneumocystis pneumonia in patients with interstitial lung disease

A prospective, randomised non-inferiority trial evaluating the efficacy and safety of low-dose Sulfamethoxazole-Trimethoprim prophylaxis for Pneumocystis pneumonia in patients with interstitial lung disease - STILD Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060898
Enrollment
120
Registered
2026-03-11
Start date
2025-07-01
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

Interstitial Lung Disease

Interventions

In the standard-dose group, one tablet of sulfamethoxazole-trimethoprim (sulfamethoxazole 400 mg / trimethoprim 80 mg) is administered orally once daily. Treatment is continued during corticosteroid t

Sponsors

Sapporo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 20 years or older with interstitial lung disease receiving corticosteroid therapy.

Exclusion criteria

Exclusion criteria: Patients with HIV infection, a history of organ transplantation, or those who are pregnant or breastfeeding, as well as patients planning pregnancy during the study period. Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) will be assigned to the renal impairment group.

Design outcomes

Primary

MeasureTime frame
Incidence of treatment discontinuation due to adverse events and incidence of severe adverse events (Grade 3 or higher according to CTCAE v5.0)

Secondary

MeasureTime frame
Incidence rate of Pneumocystis jirovecii pneumonia (PCP) Time to treatment discontinuation or occurrence of severe adverse events (Grade 3 or higher) Incidence of subclinical PCP and subsequent management

Countries

Japan

Contacts

Public ContactYusuuke Tanaka

Sapporo Medical University Department of Respiratory Medicine and Allergology

tanayou@sapmed.ac.jp011-611-2111

Outcome results

None listed

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