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

NCT03042260 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2019-02-27

No results posted yet for this study

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.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

Trimethoprim-Sulfamethoxazole

oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.

DRUG

Placebo Oral Tablet

oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Jennifer M Cuellar-Rodriguez, MD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2021-02-28
Completion
2021-08-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03042260 on ClinicalTrials.gov