<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03042260</url>
  </required_header>
  <id_info>
    <org_study_id>INF-2056-17/20-1</org_study_id>
    <nct_id>NCT03042260</nct_id>
  </id_info>
  <brief_title>Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous</brief_title>
  <official_title>Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Council of Science and Technology, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective&#xD;
      in preventing serious infectious complications (those that require hospitalization or lead to&#xD;
      death) in patients with lupus erythematosus that receive intermediate or high dose steroids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of non-viral severe infections</measure>
    <time_frame>Time on the intervention (maximum 1 year)</time_frame>
    <description>Infections that lead to hospitalization for &gt;24 hours or lead to death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events</measure>
    <time_frame>Time on the intervention (maximum 1 year)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of non-viral infections</measure>
    <time_frame>Time on the intervention (maximum 1 year)</time_frame>
    <description>All non-viral infections (severe and non-severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first episode of non-viral severe infection</measure>
    <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.</time_frame>
    <description>Infections that lead to hospitalization for &gt;24 hours or lead to death, that are not of viral etiology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause mortality or hospitalization</measure>
    <time_frame>Time on the intervention (maximum 1 year)</time_frame>
    <description>Death or hospitalization due to any cause infectious or non-infectious</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that develop infections resistant to TMP-SMX</measure>
    <time_frame>Time on the intervention (maximum 1 year)</time_frame>
    <description>Infections that would traditionally be considered susceptible to TMP-SMX</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug discontinuation</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients that require drug discontinuation due to safety concerns</description>
  </secondary_outcome>
  <other_outcome>
    <measure>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)</measure>
    <time_frame>Up to 1 year after randomization.</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Peripheral Blood Immunophenotype: Absolute number of B and T lymphocytes and NK cells per mcl of blood, measured by multiparametric flow cytometry.</measure>
    <time_frame>Up to 1 year after randomization.</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Innate Immune Cells Phagocytosis: Mean fluorescence intensity of (pHrodo) positive cells.</measure>
    <time_frame>Up to 1 year after randomization</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Innate Immune Cells Phagocytosis:Percentage of (pHrodo) positive cells.</measure>
    <time_frame>Up to 1 year after randomization</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Respiratory Burst from Neutrophils by dihydrorhodamine; expressed as mean fluorescence intensity.</measure>
    <time_frame>Up to 1 year after randomization</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Respiratory Burst from Neutrophils by dihydrorhodamine; expressed as percentage of positive cells.</measure>
    <time_frame>Up to 1 year after randomization</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Neutrophil Extracellular Traps (NETs): Mean fluorescence of Sytox Green by spectrometry from lipopolysaccharide stimulated neutrophils.</measure>
    <time_frame>Up to 1 year after randomization</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Neutrophil Extracellular Traps (NETs): Normalized mean fluorescence of elastase and Hoechst in 6 optical fields for each sample.</measure>
    <time_frame>Up to 1 year after randomization</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in systemic lupus erythematosus (SLE) activity using SLEDAI (Lupus Erythematosus Activity Index )</measure>
    <time_frame>Up to 1 year after randomization</time_frame>
    <description>Serially calculated over time at standard 3 months intervals (determined as mild, moderate or severe activity)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">310</enrollment>
  <condition>Lupus Erythematosus, Systemic</condition>
  <arm_group>
    <arm_group_label>Trimethoprim-Sulfamethoxazole (TMP-SMX)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Tablets that look exactly the same as the experimental drug, 3 times a week, for 6 months.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trimethoprim-Sulfamethoxazole</intervention_name>
    <description>oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.</description>
    <arm_group_label>Trimethoprim-Sulfamethoxazole (TMP-SMX)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemic Lupus Erythematosus according to the American College of Rheumatology&#xD;
             Criteria&#xD;
&#xD;
          -  On a daily dose of prednisone of ≥ 15 mg/d or equivalent, and that are expected to&#xD;
             remain on the this dose for at least 1 month.&#xD;
&#xD;
          -  Have signed an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absolute contraindication to receive TMP-SMX (known allergy to TMP-SMX or sulfa drugs;&#xD;
             TMP-SMX induced thrombocytopenia)&#xD;
&#xD;
          -  Received TMP-SMX treatment in the previous month&#xD;
&#xD;
          -  Creatinine clearance &lt;30ml/min/m2&#xD;
&#xD;
          -  Chronic viral infection (Hepatitis C virus, Hepatitis B virus, Human immunodeficiency&#xD;
             virus)&#xD;
&#xD;
          -  Malignant neoplasm, except for skin neoplasm&#xD;
&#xD;
          -  Primary immune deficiencies&#xD;
&#xD;
          -  Solid organ or hematopoietic stem cell transplant recipients&#xD;
&#xD;
          -  Pregnancy or Breastfeeding&#xD;
&#xD;
          -  Current active infection, except mild active infections that to the judgement of the&#xD;
             primary investigator do not jeopardize the study outcomes (e.g. tinea).&#xD;
&#xD;
          -  Uncontrolled chronic infection (e.g. tuberculosis- intensive phase treatment), except&#xD;
             mild active chronic infections that to the judgement of the primary investigator do&#xD;
             not jeopardize the study outcomes (e.g. onychomycosis).&#xD;
&#xD;
          -  Controlled chronic infection, that needs to be treated or prevented with TMP-SMX.&#xD;
&#xD;
          -  Absolute Neutrophil Count &lt; 750/mm3, platelets &lt;30x10^9/L, o hemoglobin &lt;7 g/dL&#xD;
&#xD;
          -  Patients receiving Methotrexate&#xD;
&#xD;
          -  Patients participating in another research study that to the judgement of the&#xD;
             principal investigator could jeopardize the safety or efficacy of the study drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer M Cuellar-Rodriguez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrea Wisniowski-Yañez, MD</last_name>
    <phone>525554870900</phone>
    <phone_ext>2420</phone_ext>
    <email>andiewsk@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jennifer M Cuellar-Rodriguez, MD</last_name>
    <phone>525554870900</phone>
    <phone_ext>2420</phone_ext>
    <email>jenncuellar@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán</name>
      <address>
        <city>Mexico Distrito Federal</city>
        <state>DF</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Wisniowski, MD</last_name>
      <phone>5554870900</phone>
      <phone_ext>2420</phone_ext>
      <email>andiewsk@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Jennifer Cuellar-Rodriguez, MD</last_name>
      <phone>5554870900</phone>
      <phone_ext>2421</phone_ext>
      <email>jennifer.cuellar@infecto.mx</email>
    </contact_backup>
    <investigator>
      <last_name>Jennifer M Cuellar-Rodriguez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Danza A, Ruiz-Irastorza G. Infection risk in systemic lupus erythematosus patients: susceptibility factors and preventive strategies. Lupus. 2013 Oct;22(12):1286-94. doi: 10.1177/0961203313493032.</citation>
    <PMID>24098001</PMID>
  </reference>
  <reference>
    <citation>Cervera R, Khamashta MA, Font J, Sebastiani GD, Gil A, Lavilla P, Mejia JC, Aydintug AO, Chwalinska-Sadowska H, de Ramon E, Fernandez-Nebro A, Galeazzi M, Valen M, Mathieu A, Houssiau F, Caro N, Alba P, Ramos-Casals M, Ingelmo M, Hughes GR; European Working Party on Systemic Lupus Erythematosus. Morbidity and mortality in systemic lupus erythematosus during a 10-year period: a comparison of early and late manifestations in a cohort of 1,000 patients. Medicine (Baltimore). 2003 Sep;82(5):299-308. doi: 10.1097/01.md.0000091181.93122.55.</citation>
    <PMID>14530779</PMID>
  </reference>
  <reference>
    <citation>Barber C, Gold WL, Fortin PR. Infections in the lupus patient: perspectives on prevention. Curr Opin Rheumatol. 2011 Jul;23(4):358-65. doi: 10.1097/BOR.0b013e3283476cd8.</citation>
    <PMID>21532484</PMID>
  </reference>
  <reference>
    <citation>Bwakura-Dangarembizi M, Kendall L, Bakeera-Kitaka S, Nahirya-Ntege P, Keishanyu R, Nathoo K, Spyer MJ, Kekitiinwa A, Lutaakome J, Mhute T, Kasirye P, Munderi P, Musiime V, Gibb DM, Walker AS, Prendergast AJ. A randomized trial of prolonged co-trimoxazole in HIV-infected children in Africa. N Engl J Med. 2014 Jan 2;370(1):41-53. doi: 10.1056/NEJMoa1214901. Erratum In: N Engl J Med. 2014 Jan 30;370(5):488. Dosage error in article text.</citation>
    <PMID>24382064</PMID>
  </reference>
  <reference>
    <citation>Vananuvat P, Suwannalai P, Sungkanuparph S, Limsuwan T, Ngamjanyaporn P, Janwityanujit S. Primary prophylaxis for Pneumocystis jirovecii pneumonia in patients with connective tissue diseases. Semin Arthritis Rheum. 2011 Dec;41(3):497-502. doi: 10.1016/j.semarthrit.2011.05.004. Epub 2011 Sep 29.</citation>
    <PMID>21959291</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</investigator_affiliation>
    <investigator_full_name>Jennifer M. Cuellar-Rodríguez</investigator_full_name>
    <investigator_title>Medical Sciences Investigator</investigator_title>
  </responsible_party>
  <keyword>trimethoprim, sulfamethoxazole drug combination</keyword>
  <keyword>Infection</keyword>
  <keyword>Prophylaxis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trimethoprim</mesh_term>
    <mesh_term>Trimethoprim, Sulfamethoxazole Drug Combination</mesh_term>
    <mesh_term>Sulfamethoxazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03042260
org study id: INF-2056-17/20-1
nct id: NCT03042260
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Frequency of non-viral severe infections
time frame: Time on the intervention (maximum 1 year)
description: Infections that lead to hospitalization for >24 hours or lead to death.
measure: Serious Adverse Events
time frame: Time on the intervention (maximum 1 year)
description: 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.
measure: Frequency of non-viral infections
time frame: Time on the intervention (maximum 1 year)
description: All non-viral infections (severe and non-severe)
measure: Time to first episode of non-viral severe infection
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.
description: Infections that lead to hospitalization for >24 hours or lead to death, that are not of viral etiology.
measure: All cause mortality or hospitalization
time frame: Time on the intervention (maximum 1 year)
description: Death or hospitalization due to any cause infectious or non-infectious
measure: Proportion of patients that develop infections resistant to TMP-SMX
time frame: Time on the intervention (maximum 1 year)
description: Infections that would traditionally be considered susceptible to TMP-SMX
measure: Drug discontinuation
time frame: 1 year
description: Number of patients that require drug discontinuation due to safety concerns
measure: 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)
time frame: Up to 1 year after randomization.
description: 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.
measure: Peripheral Blood Immunophenotype: Absolute number of B and T lymphocytes and NK cells per mcl of blood, measured by multiparametric flow cytometry.
time frame: Up to 1 year after randomization.
description: 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.
measure: Innate Immune Cells Phagocytosis: Mean fluorescence intensity of (pHrodo) positive cells.
time frame: Up to 1 year after randomization
description: 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.
measure: Innate Immune Cells Phagocytosis:Percentage of (pHrodo) positive cells.
time frame: Up to 1 year after randomization
description: 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.
measure: Respiratory Burst from Neutrophils by dihydrorhodamine; expressed as mean fluorescence intensity.
time frame: Up to 1 year after randomization
description: 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.
measure: Respiratory Burst from Neutrophils by dihydrorhodamine; expressed as percentage of positive cells.
time frame: Up to 1 year after randomization
description: 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.
measure: Neutrophil Extracellular Traps (NETs): Mean fluorescence of Sytox Green by spectrometry from lipopolysaccharide stimulated neutrophils.
time frame: Up to 1 year after randomization
description: 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.
measure: Neutrophil Extracellular Traps (NETs): Normalized mean fluorescence of elastase and Hoechst in 6 optical fields for each sample.
time frame: Up to 1 year after randomization
description: 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.
measure: Changes in systemic lupus erythematosus (SLE) activity using SLEDAI (Lupus Erythematosus Activity Index )
time frame: Up to 1 year after randomization
description: Serially calculated over time at standard 3 months intervals (determined as mild, moderate or severe activity)
arm group label: Trimethoprim-Sulfamethoxazole (TMP-SMX)
arm group type: Experimental
description: 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.
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
intervention type: Drug
intervention name: Trimethoprim-Sulfamethoxazole
description: oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
arm group label: Trimethoprim-Sulfamethoxazole (TMP-SMX)
intervention type: Drug
intervention name: Placebo Oral Tablet
description: oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer M Cuellar-Rodriguez, MD
role: Principal Investigator
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Andrea Wisniowski-Yañez, MD
phone: 525554870900
phone ext: 2420
email: andiewsk@gmail.com
last name: Jennifer M Cuellar-Rodriguez, MD
phone: 525554870900
phone ext: 2420
email: jenncuellar@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Mexico
citation: Danza A, Ruiz-Irastorza G. Infection risk in systemic lupus erythematosus patients: susceptibility factors and preventive strategies. Lupus. 2013 Oct;22(12):1286-94. doi: 10.1177/0961203313493032.
PMID: 24098001
citation: Cervera R, Khamashta MA, Font J, Sebastiani GD, Gil A, Lavilla P, Mejia JC, Aydintug AO, Chwalinska-Sadowska H, de Ramon E, Fernandez-Nebro A, Galeazzi M, Valen M, Mathieu A, Houssiau F, Caro N, Alba P, Ramos-Casals M, Ingelmo M, Hughes GR; European Working Party on Systemic Lupus Erythematosus. Morbidity and mortality in systemic lupus erythematosus during a 10-year period: a comparison of early and late manifestations in a cohort of 1,000 patients. Medicine (Baltimore). 2003 Sep;82(5):299-308. doi: 10.1097/01.md.0000091181.93122.55.
PMID: 14530779
citation: Barber C, Gold WL, Fortin PR. Infections in the lupus patient: perspectives on prevention. Curr Opin Rheumatol. 2011 Jul;23(4):358-65. doi: 10.1097/BOR.0b013e3283476cd8.
PMID: 21532484
citation: Bwakura-Dangarembizi M, Kendall L, Bakeera-Kitaka S, Nahirya-Ntege P, Keishanyu R, Nathoo K, Spyer MJ, Kekitiinwa A, Lutaakome J, Mhute T, Kasirye P, Munderi P, Musiime V, Gibb DM, Walker AS, Prendergast AJ. A randomized trial of prolonged co-trimoxazole in HIV-infected children in Africa. N Engl J Med. 2014 Jan 2;370(1):41-53. doi: 10.1056/NEJMoa1214901. Erratum In: N Engl J Med. 2014 Jan 30;370(5):488. Dosage error in article text.
PMID: 24382064
citation: Vananuvat P, Suwannalai P, Sungkanuparph S, Limsuwan T, Ngamjanyaporn P, Janwityanujit S. Primary prophylaxis for Pneumocystis jirovecii pneumonia in patients with connective tissue diseases. Semin Arthritis Rheum. 2011 Dec;41(3):497-502. doi: 10.1016/j.semarthrit.2011.05.004. Epub 2011 Sep 29.
PMID: 21959291
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
investigator full name: Jennifer M. Cuellar-Rodríguez
investigator title: Medical Sciences Investigator
mesh term: Infections
mesh term: Lupus Erythematosus, Systemic
mesh term: Trimethoprim
mesh term: Trimethoprim, Sulfamethoxazole Drug Combination
mesh term: Sulfamethoxazole
sharing ipd: No
ipd description: Undecided