Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMP/SMX (with PJP high risk) | Experimental | AIIRD 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 Intervention | AIIRD patients who have PJP high risk and do not receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment. | |
| TMP/SMX (with PJP low-risk) | Experimental | AIIRD 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 Intervention | AIIRD patients who have PJP low risk and do not receive prophylactic Trimethoprim/ Sulfamethoxazole (TMP/SMZ) treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimethoprim/Sulfamethoxazole | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TMP/SMZ related adverse drug reactions | Symptoms and signs that may be related to adverse drug reactions during treatment (such as nausea, vomiting, anorexia, jaundice, rashes and hives, and shock); incidence, duration and severity of adverse events | 6 months, 12 months |
| PJP-related mortality |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingli Dong | Contact | 02783665519 | tjhdongll@163.com | |
| Shaozhe Cai | Contact | 02783665518 | 540361903@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Lingli Dong | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 43003 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jul 4, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
PJP-related mortality at the end of month 6. |
| 6 months, 12 months |
| All cause mortality | All cause mortality | 6 months, 12 months |
| Jul 6, 2024 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D011020 | Pneumonia, Pneumocystis |
| D001327 | Autoimmune Diseases |
| D003240 | Connective Tissue Diseases |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016720 | Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007154 | Immune System Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided