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

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230606002
Enrollment
248
Registered
2023-06-06
Start date
2022-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

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

Interventions

TMP/SMX was the only agent used for primary prophylaxis in the intervention group of this study. Participants who previously used TMP/SMX must discontinue for at least two weeks before starting TMP/SM
Active Comparator Drug,No Intervention No treatment
TMX/SMX primary prophylaxis,Control

Sponsors

Mahidol university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Thailand

Contacts

Public ContactPaopat Munthananuchat

Faculty of Medicine Ramathibodi Hospital, Mahidol University

paopat.mun@gmail.com022011301

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026