Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous
NCT ID: NCT03042260
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
310 participants
INTERVENTIONAL
2017-03-01
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Trimethoprim-Sulfamethoxazole (TMP-SMX)
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.
Trimethoprim-Sulfamethoxazole
oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
Placebo
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.
Placebo Oral Tablet
oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
Interventions
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Trimethoprim-Sulfamethoxazole
oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
Placebo Oral Tablet
oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
Eligibility Criteria
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Inclusion Criteria
* On a daily dose of prednisone of ≥ 15 mg/d or equivalent, and that are expected to remain on the this dose for at least 1 month.
* Have signed an informed consent
Exclusion Criteria
* Received TMP-SMX treatment in the previous month
* Creatinine clearance \<30ml/min/m2
* Chronic viral infection (Hepatitis C virus, Hepatitis B virus, Human immunodeficiency virus)
* Malignant neoplasm, except for skin neoplasm
* Primary immune deficiencies
* Solid organ or hematopoietic stem cell transplant recipients
* Pregnancy or Breastfeeding
* Current active infection, except mild active infections that to the judgement of the primary investigator do not jeopardize the study outcomes (e.g. tinea).
* Uncontrolled chronic infection (e.g. tuberculosis- intensive phase treatment), except mild active chronic infections that to the judgement of the primary investigator do not jeopardize the study outcomes (e.g. onychomycosis).
* Controlled chronic infection, that needs to be treated or prevented with TMP-SMX.
* Absolute Neutrophil Count \< 750/mm3, platelets \<30x10\^9/L, o hemoglobin \<7 g/dL
* Patients receiving Methotrexate
* Patients participating in another research study that to the judgement of the principal investigator could jeopardize the safety or efficacy of the study drug.
18 Years
ALL
No
Sponsors
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National Council of Science and Technology, Mexico
OTHER
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
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Jennifer M. Cuellar-Rodríguez
Medical Sciences Investigator
Principal Investigators
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Jennifer M Cuellar-Rodriguez, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Locations
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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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INF-2056-17/20-1
Identifier Type: -
Identifier Source: org_study_id
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