A randomized clinical trial on the efficacy and tolerability of dose reduction and escalation regimen of Trimethoprim/Sulfamethoxazole (TMP/SMX) in patients with rheumatic diseases
Not Applicable
- Conditions
- Rheumatic diseases
- Registration Number
- JPRN-UMIN000007727
- Lead Sponsor
- Tokyo Medical and Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 165
Inclusion Criteria
Not provided
Exclusion Criteria
1. When a patient refuses to give or withdraws his or her consent 2. When a patient has contraindications or contraindications in principle (see attachment 3) for TMP/SMX 3. When a patient uses biologics concomitantly 4. When a patient has a history of Pneumocystis pneumonia 5. When a patient has uncontrollable comorbidities (i.e., severe diabetes, unstable ischemic heart disease, stroke within the last 1 year) 6. When a patient's body weight is less than 40kg 7. When a patient is under breastfeeding or pregnant, or has a plan to be pregnant in 24 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PCP prevention rate at 24 weeks of the 1g group (1g/day of TMP/SMX, the regular dose) and the escalation group (start 0.1g/day of TMP/SMX and increase gradually up to a half of the regular dose)
- Secondary Outcome Measures
Name Time Method 1. PCP prevention rate at 24 weeks of the 1g group and the 0.5g group (0.5g/day of TMP/SMX, a half of the regular dose) 2. PCP prevention rate at 24 weeks of the 0.5 g group and the escalation group 3. PCP prevention rate at 52 weeks of the 1g group, the 0.5g group and the escalation group 4. Withdrawal rates of TMP/SMX at 24 weeks and 52 weeks 5. Safety (incidence of adverse events and serious adverse events, side effects and contents of these severe side effects) 6. Situations of TMP/SMX administration up to 52 weeks