The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective in preventing serious infectious complications (those that require hospitalization or lead to death) in patients with lupus erythematosus that receive intermediate or high dose steroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
310
oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico
RECRUITINGFrequency of non-viral severe infections
Infections that lead to hospitalization for \>24 hours or lead to death.
Time frame: Time on the intervention (maximum 1 year)
Serious Adverse Events
A serious adverse event is an adverse event that leads to death, persistent disability, leads to hospitalization or increase in length of hospitalization. Additionally, an adverse event that does not immediately put life at risk, but that requires a medical or surgical intervention to prevent a serious adverse event.
Time frame: Time on the intervention (maximum 1 year)
Frequency of non-viral infections
All non-viral infections (severe and non-severe)
Time frame: Time on the intervention (maximum 1 year)
Time to first episode of non-viral severe infection
Infections that lead to hospitalization for \>24 hours or lead to death, that are not of viral etiology.
Time frame: From 2 weeks after randomization until the date of the first episode of a non-viral severe infection, up to 1 year after randomization.
All cause mortality or hospitalization
Death or hospitalization due to any cause infectious or non-infectious
Time frame: Time on the intervention (maximum 1 year)
Proportion of patients that develop infections resistant to TMP-SMX
Infections that would traditionally be considered susceptible to TMP-SMX
Time frame: Time on the intervention (maximum 1 year)
Drug discontinuation
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Number of patients that require drug discontinuation due to safety concerns
Time frame: 1 year