Trimethoprim/Sulfamethoxazole for Pneumocystis jirovecii Pneumonia prophylaxis in B-cell lymphoma patients receiving chemotherapy: A multicenter randomized double-blinded placebo-controlled trial

Phase 3

• Conditions: Age more than 18 yearsDiffused larged B- cell lymphoma patients (DLBCL)Chemotherapy with CHOP or R- CHOP; Diffused larged B- cell lymphoma (DLBCL); chemotherapy; R- Pneumocystis jirovecii pneumonia; Trimethoprim/Sulfamethoxazole

• Registration Number: TCTR20191025002
• Lead Sponsor: Faculty of Medicine Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-25
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

1. Diffused larged B-cell lymphoma patients (DLBCL), 18 years of age or older
2. Intent to or receiving chemotherapy with CHOP or R-CHOP not more than 3 cycles

Exclusion Criteria

1. Receiving Trimethoprim/Sulfamethoxazole or Dapsone for pneumocystis jirovecii pneumonia prophylaxis before recruitment
2. History of pneumocystis jirovecii pneumonia before recruitment
3. Receiving Trimethoprim/Sulfamethoxazole or Dapson within 1 month before recruitment
4. Severe adverse reaction or allergic to Trimethoprim/Sulfamethoxazole or sulfa drug
5. Creatinine clearance < 30 mg/dL
6. Women who were pregnant or during breast feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pneumocystis jirovecii pneumonia 30 days after cessation of chemotherapy Incidence rate, Number of population

Secondary Outcome Measures

Name	Time	Method
Cumulative dose of prednisolone in pneumocystis jirovecii pneumonia patients 30 days after cessation of chemotherapy Cumulative dose of prednisolone,Incidence of bacterial infection 30 days after cessation of chemotherapy Incidence rate, number of population,Adverse effect of treatment 14 days after cessation of chemotherapy 1. Laboratory test 2. Allergic reaction 3. Nausea and vomiting,The period of time of pneumocystis jirovecii pneumonia event after chemotherapy 30 days after cessation of chemotherapy Time period ,Incidence of pneumocystis jirovecii pneumonia after treatment 90 day after cessation of chemotherapy 90-day incidence rate of pneumocystis jirovecii pneumonia