A study of role of trimethoprim-sulfamethoxazole in opportunistic infection prevention in lupus patients taking low-level immunosuppressive treatment

Phase 2

Completed

• Conditions: Trimethoprim-sulfamethoxazole primary prophylaxis in lupus patients taking low-level immunosuppressive treatment; Systemic lupus erythematosus; Lupus; Trimethoprim-sulfamethoxazole; Pneumocystis pneumonia

• Registration Number: TCTR20230606002
• Lead Sponsor: Mahidol university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-04-07
• Study Start: 2023-06-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1.Lupus patients diagnosed by 2019 EULAR/ACR Criteria for SLE
2.Taking low level immunosuppressive treatment

Exclusion Criteria

1.History of TMP/SMX allergy
2.Need for TMP/SMX treatment
3.Overlap syndrome
4.HIV infection
5.Pregnancy
6. Cancer patient
7.Transplant patient
8.History of TMP/SMX sensitive opportunistic infections within 6 months
9.History of pulse immunosuppressive treatment within 6 months
10.History of CMV infection or CMV disease within 3 months
11.Received pentamidine or dapsone for any indication prior to enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of TMP/SMX sensitive OIs include pneumocystis pneumonia, toxoplasmosis and nocardiosis one year after enrollment Incidence rate by medical record review

Secondary Outcome Measures

Name	Time	Method
ADRs of TMP/SMX one year after enrollment Common Terminology Criteria for Adverse Events (CTCAE) version 5.0