Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous

Phase 4

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Drug: Trimethoprim-Sulfamethoxazole; Drug: Placebo Oral Tablet

• Registration Number: NCT03042260
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Study Start: 2017-03-01
• Status Verified: 2018-08
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27
• Primary Completion: 2021-02
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Systemic Lupus Erythematosus according to the American College of Rheumatology 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

• Absolute contraindication to receive TMP-SMX (known allergy to TMP-SMX or sulfa drugs; TMP-SMX induced thrombocytopenia)
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trimethoprim-Sulfamethoxazole (TMP-SMX)	Trimethoprim-Sulfamethoxazole	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.
Placebo	Placebo Oral Tablet	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.

Primary Outcome Measures

Name	Time	Method
Frequency of non-viral severe infections	Time on the intervention (maximum 1 year)	Infections that lead to hospitalization for \>24 hours or lead to death.

Secondary Outcome Measures

Name	Time	Method
Serious Adverse Events	Time on the intervention (maximum 1 year)	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.
Frequency of non-viral infections	Time on the intervention (maximum 1 year)	All non-viral infections (severe and non-severe)
Proportion of patients that develop infections resistant to TMP-SMX	Time on the intervention (maximum 1 year)	Infections that would traditionally be considered susceptible to TMP-SMX
Drug discontinuation	1 year	Number of patients that require drug discontinuation due to safety concerns
Time to first episode of non-viral severe infection	From 2 weeks after randomization until the date of the first episode of a non-viral severe infection, up to 1 year after randomization.	Infections that lead to hospitalization for \>24 hours or lead to death, that are not of viral etiology.
All cause mortality or hospitalization	Time on the intervention (maximum 1 year)	Death or hospitalization due to any cause infectious or non-infectious

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico Distrito Federal, DF, Mexico