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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

800 Participants
are divided into 4 treatment groups
Group A: TMP/SMX (with PJP high risk)Experimental treatment 1 intervention
Group B: no TMP/SMX (with PJP high risk)No intervention 0 interventions
Group C: TMP/SMX (with PJP low-risk)Experimental treatment 1 intervention
Group D: no TMP/SMX (with PJP low-risk)No intervention 0 interventions

Trial outcomes

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.

Time frame
6 months, 12 months

Secondary outcomes

1

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

Time frame
6 months, 12 months
2

PJP-related mortality

PJP-related mortality at the end of month 6.

Time frame
6 months, 12 months
3

All cause mortality

All cause mortality

Time frame
6 months, 12 months

Other outcomes

Sponsors and contacts

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