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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03042260
• Date of registration: 10/01/2017
• Prospective Registration: Yes
• Primary sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Public title: Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous
• Scientific title: Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial
• Date of first enrolment: March 1, 2017
• Target sample size: 310
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03042260
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: Andrea Wisniowski, MD

• Name: Andrea Wisniowski-Yañez, MD

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

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Trimethoprim-Sulfamethoxazole

Drug: Placebo Oral Tablet

Primary Outcome(s)

Frequency of non-viral severe infections [Time Frame: Time on the intervention (maximum 1 year)]

Secondary Outcome(s)

All cause mortality or hospitalization [Time Frame: Time on the intervention (maximum 1 year)]

Frequency of non-viral infections [Time Frame: Time on the intervention (maximum 1 year)]

Proportion of patients that develop infections resistant to TMP-SMX [Time Frame: Time on the intervention (maximum 1 year)]

Drug discontinuation [Time Frame: 1 year]

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.]

Serious Adverse Events [Time Frame: Time on the intervention (maximum 1 year)]

Secondary ID(s)

INF-2056-17/20-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Council of Science and Technology, Mexico