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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20191025002

Enrollment

328

Registered

2019-10-25

Start date

2019-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age more than 18 years Diffused larged B&#45

Interventions

Take Trimethoprim/Sulfamethoxazole single strength (Trimethoprim 80 mg and Sulfamethoxazole 160 mg) 2 tabs oral thrice a week every Monday&#44

Wednesday and Friday for pneumocystis jirovecii pneumonia prophylaxis until 1 month after chemotherapy cessation,Take placebo 2 tabs oral thrice a week every Monday&#44

Wednesday and Friday for pneumocystis jirovecii pneumonia prophylaxis until 1 month after chemotherapy cessation

Active Comparator Drug,Placebo Comparator Drug

Trimethoprim/Sulfamethoxazole,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Incidence of pneumocystis jirovecii pneumonia 30 days after cessation of chemotherapy Incidence rate, Number of population	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactMethee Chayakulkeeree

Faculty of Medicine Siriraj Hospital

methee.cha@mahidol.ac.th+66850632416

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Trimethoprim/Sulfamethoxazole for Pneumocystis jirovecii Pneumonia prophylaxis in B&#45;cell lymphoma patients receiving chemotherapy: A multicenter randomized double&#45;blinded placebo&#45;controlled trial