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NCT Number: NCT06499233

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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;

Exclusion criteria

  • 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).

Treatment and study plan

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).

Other names: TMP/SMX

Primary outcomes

  1. Number of participants with PJP infection

    Time frame: 6 months, 12 months

    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.

Secondary outcomes

  1. TMP/SMZ related adverse drug reactions

    Time frame: 6 months, 12 months

    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

  2. PJP-related mortality

    Time frame: 6 months, 12 months

    PJP-related mortality at the end of month 6.

  3. All cause mortality

    Time frame: 6 months, 12 months

    All cause mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Lingli Dong

CONTACT

[email protected]

02783665519

Shaozhe Cai

CONTACT

[email protected]

02783665518

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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