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Tests treatment safety and results for Pneumonia, Pneumocystis
Official title Efficacy and Safety of Prophylactic Treatment for Pneumocystis Jirovecii Pneumonia in Patients With Autoimmune Inflammatory Rheumatic Disease
ClinicalTrials.gov ID: NCT06499233
What this study is testing
What is Trimethoprim/Sulfamethoxazole?
Trimethoprim/Sulfamethoxazole is an investigational medicine, being studied as a potential treatment for pneumonia, pneumocystis.
Also referred to as TMP/SMX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- The patient was at least 18 years old at the time of enrollment;
You likely can't join if
- Serious health problems or diseases, including (but not limited to) the following: severe liver damage (ALT, AST elevated above normal value by more...
- Screening test indicates infection with human immunodeficiency virus (HIV), history of lymphomatous hyperplasia of the lymphatic tissue or any...
- 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...
- Patients who refuse to comply with the requirements of this study and complete the study;
See the full eligibility criteria
- 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;
- 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 \ 445umol/L), severe...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.