A Phase 4 interventional study of Trimethoprim-Sulfamethoxazole and Placebo Oral Tablet in Lupus Erythematosus, Systemic, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Status unknown at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Phase 4, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 310 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 141 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Trimethoprim-Sulfamethoxazole 180mg/800mg oral tablet, 3 times a week, for 6 months. Subjects may remain on the drug longer (maximum 1 year), if they continue to receive intermediate or high dose steroids at the end of 6 months.
Drug: Trimethoprim-Sulfamethoxazole
Tablets that look exactly the same as the experimental drug, 3 times a week, for 6 months. Subjects may remain on the placebo longer (maximum 1 year), if they continue to receive intermediate or high dose steroids at the end of 6 months.
Drug: Placebo Oral Tablet
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.
Frequency 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
Number of patients that require drug discontinuation due to safety concerns
Time frame: 1 year
Peripheral Blood Immunophenotype: B and T lymphocytes and Natural Killer (NK) cells measured by multiparametric flow cytometry. These variables will be expressed as % of total peripheral blood mononuclear cells (PBMC)
In a random sample of a subset of patients, serially examined parameters at baseline, development of a first episode of severe infection or at the end of follow-up. Variables will be described as mean and standard deviation and groups will be compared by means of student T test. Association will be assessed by ANCOVA.
Time frame: Up to 1 year after randomization.
Peripheral Blood Immunophenotype: Absolute number of B and T lymphocytes and NK cells per mcl of blood, measured by multiparametric flow cytometry.
In a random sample of a subset of patients, serially examined parameters at baseline, development of a first episode of severe infection or at the end of follow-up. Variables will be described as mean and standard deviation and groups will be compared by means of student T test. Association will be assessed by ANCOVA.
Time frame: Up to 1 year after randomization.
Innate Immune Cells Phagocytosis: Mean fluorescence intensity of (pHrodo) positive cells.
In a random sample of a subset of patients, serially examined parameters at baseline, development of a first episode of severe infection or at the end of follow-up. Variables will be described as mean and standard deviation and groups will be compared by means of student T test. Association will be assessed by ANCOVA.
Time frame: Up to 1 year after randomization
Innate Immune Cells Phagocytosis:Percentage of (pHrodo) positive cells.
In a random sample of a subset of patients, serially examined parameters at baseline, development of a first episode of severe infection or at the end of follow-up. Variables will be described as mean and standard deviation and groups will be compared by means of student T test. Association will be assessed by ANCOVA.
Time frame: Up to 1 year after randomization
Respiratory Burst from Neutrophils by dihydrorhodamine; expressed as mean fluorescence intensity.
In a random sample of a subset of patients, serially examined parameters at baseline, development of a first episode of severe infection or at the end of follow-up. Variables will be described as mean and standard deviation and groups will be compared by means of student T test. Association will be assessed by ANCOVA.
Time frame: Up to 1 year after randomization
Respiratory Burst from Neutrophils by dihydrorhodamine; expressed as percentage of positive cells.
In a random sample of a subset of patients, serially examined parameters at baseline, development of a first episode of severe infection or at the end of follow-up. Variables will be described as mean and standard deviation and groups will be compared by means of student T test. Association will be assessed by ANCOVA.
Time frame: Up to 1 year after randomization
Neutrophil Extracellular Traps (NETs): Mean fluorescence of Sytox Green by spectrometry from lipopolysaccharide stimulated neutrophils.
In a random sample of a subset of patients, serially examined parameters at baseline, development of a first episode of severe infection or at the end of follow-up. Variables will be described as mean and standard deviation and groups will be compared by means of student T test. Association will be assessed by ANCOVA.
Time frame: Up to 1 year after randomization
Neutrophil Extracellular Traps (NETs): Normalized mean fluorescence of elastase and Hoechst in 6 optical fields for each sample.
In a random sample of a subset of patients, serially examined parameters at baseline, development of a first episode of severe infection or at the end of follow-up. Variables will be described as mean and standard deviation and groups will be compared by means of student T test. Association will be assessed by ANCOVA.
Time frame: Up to 1 year after randomization
Changes in systemic lupus erythematosus (SLE) activity using SLEDAI (Lupus Erythematosus Activity Index )
Serially calculated over time at standard 3 months intervals (determined as mild, moderate or severe activity)
Time frame: Up to 1 year after randomization
Plan to share: No — Undecided
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran