Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease
1 other identifier
interventional
800
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2024
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedStudy Start
First participant enrolled
July 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 1, 2024
September 1, 2024
2 years
July 6, 2024
September 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with PJP infection
Defined as documentation/diagnosis of Pneumocystis from a properly obtained specimen (induced sputum, bronchoalveolar lavage, or biopsy) in a patient with clinical manifestations compatible with PJP.
6 months, 12 months
Secondary Outcomes (3)
TMP/SMZ related adverse drug reactions
6 months, 12 months
PJP-related mortality
6 months, 12 months
All cause mortality
6 months, 12 months
Study Arms (4)
TMP/SMX (with PJP high risk)
EXPERIMENTALAIIRD patients who have PJP high risk and receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment; Drug intervention: Patients receive Trimethoprim/Sulfamethoxazole (TMP/SMX) 480 mg p.o. every day as PJP Prophylaxis.
no TMP/SMX (with PJP high risk)
NO INTERVENTIONAIIRD patients who have PJP high risk and do not receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment.
TMP/SMX (with PJP low-risk)
EXPERIMENTALAIIRD patients who have PJP low risk and receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment; Drug intervention: Patients receive Trimethoprim/Sulfamethoxazole (TMP/SMX) 480 mg p.o. every day as PJP Prophylaxis.
no TMP/SMX (with PJP low-risk)
NO INTERVENTIONAIIRD patients who have PJP low risk and do not receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment.
Interventions
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).
Eligibility Criteria
You may qualify if:
- The patient was diagnosed with AIIRD according to the International Classification of Diseases and had received steroids or immunosuppressive therapy;
- The patient had not received standard PJP treatment before enrollment, including the first-line treatment drug TMP/SMZ, or other second-line treatment drugs (including Pentamidine, Atorvastatin, Caspofungin, etc.);
- The patient was at least 18 years old at the time of enrollment;
You may not qualify if:
- Serious health problems or diseases, including (but not limited to) the following: severe liver damage (ALT, AST elevated above normal value by more than 5 times), severe renal insufficiency (GFR \< 30mL/min or Scr \> 445umol/L), severe myelosuppression (Hb \< 65g/L, PLT \< 25×10\^9/L or neutrophils \< 0.5×10\^9/L);
- Screening test indicates infection with human immunodeficiency virus (HIV), history of lymphomatous hyperplasia of the lymphatic tissue or any malignant tumor of any organ system within the past 5 years, or history of organ transplantation;
- Participants with a history of allergy to sulfonamide drugs, megaloblastic anemia due to folate deficiency;
- Pregnant and lactating women;
- Any medical or psychological condition that the investigator believes would interfere with the participant's ability to comply with the protocol or complete the study;
- Patients who refuse to comply with the requirements of this study and complete the study;
- Any other situation that the investigator considers unsuitable for participation in the study (for reasons including but not limited to management reasons).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 43003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lingli Dong
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 6, 2024
First Posted
July 12, 2024
Study Start
July 20, 2024
Primary Completion (Estimated)
July 20, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share