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Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease

NCT06499233 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2024-10-01

No results posted yet for this study

Summary

This is an open-labeled, prospective clinical study aims at collecting and analyzing baseline characteristics of autoimmune inflammatory rheumatic disease (AIIRD) patients receiving sulfanilamide for preventive purposes, as well as subsequent follow-up data, in order to assess the efficacy and safety of the medication. Additionally, through a stratified analysis of risk factors, the investigators aim to identify the AIIRD population that would benefit most from preventive medication based on a favorable benefit-risk ratio.

Conditions

  • Pneumonia, Pneumocystis
  • Autoimmune Inflammatory Rheumatic Disease
  • Autoimmune Diseases
  • Connective Tissue Disease
  • Prevention

Interventions

DRUG

Trimethoprim/Sulfamethoxazole

Patients received Trimethoprim/Sulfamethoxazole (TMP/SMX) 480 mg p.o. every day as PJP Prophylaxis; Treatment duration: at least 28 days, adjusted by the clinician based on the severity of the patient's condition, the patient's tolerance to the drug and treatment willingness).

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Lingli Dong · Tongji Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-20
Primary Completion
2026-07-20
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06499233 on ClinicalTrials.gov