Lupus Erythematosus, SystemicPhase 4NCT03042260
Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous
A Phase 4 study testing Trimethoprim-Sulfamethoxazole in people with Lupus Erythematosus, Systemic, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Trimethoprim-Sulfamethoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2017to Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, 14080
Andrea Wisniowski, MD, 5554870900 ext. 2420, andiewsk@gmail.com
Jennifer Cuellar-Rodriguez, MD, 5554870900 ext. 2421, jennifer.cuellar@infecto.mx
About this study
Official title: Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial
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
- Being tested
- Trimethoprim-Sulfamethoxazole, Placebo Oral Tablet
- Keywords
- trimethoprim, sulfamethoxazole drug combination, Infection, Prophylaxis
- Medical subject headings
- Lupus Erythematosus, Systemic, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim-SulfamethoxazoleDrug
oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
Placebo Oral TabletDrug
oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Trimethoprim-Sulfamethoxazole (TMP-SMX) | Experimental | 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. Receives: Drug: Trimethoprim-Sulfamethoxazole |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of non-viral severe infections
Infections that lead to hospitalization for >24 hours or lead to death.
Measured: Time on the intervention (maximum 1 year)
Secondary outcomes (6)
Serious Adverse Events
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.
Measured: Time on the intervention (maximum 1 year)
Frequency of non-viral infections
All non-viral infections (severe and non-severe)
Measured: Time on the intervention (maximum 1 year)
Time to first episode of non-viral severe infection
Infections that lead to hospitalization for >24 hours or lead to death, that are not of viral etiology.
Measured: From 2 weeks after randomization until the date of the first episode of a non-viral severe infection, up to 1 year after randomization.
All cause mortality or hospitalization
Death or hospitalization due to any cause infectious or non-infectious
Measured: Time on the intervention (maximum 1 year)
Proportion of patients that develop infections resistant to TMP-SMX
Infections that would traditionally be considered susceptible to TMP-SMX
Measured: Time on the intervention (maximum 1 year)
Drug discontinuation
Number of patients that require drug discontinuation due to safety concerns
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completionFeb 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Jennifer M. Cuellar-Rodríguez, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Jennifer M Cuellar-Rodriguez, MD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042260
- Sponsor's protocol ID
- INF-2056-17/20-1
- Status last verified
- Aug 2018
- First submitted
- 10 Jan 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Publications
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.
PubMed 24098001Cervera 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.
PubMed 14530779Barber 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.
PubMed 21532484Bwakura-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.
PubMed 24382064Vananuvat 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.
PubMed 21959291
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03042260
- Acronym / sponsor ID
- INF-2056-17/20-1
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- trimethoprim, sulfamethoxazole drug combination, Infection, Prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trimethoprim-Sulfamethoxazole (TMP-SMX) | Experimental | Drug: Trimethoprim-SulfamethoxazoleTrimethoprim-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 comparator | Drug: Placebo Oral TabletTablets 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim-Sulfamethoxazoleoral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year. | Drug | Trimethoprim-Sulfamethoxazole (TMP-SMX) |
| Placebo Oral Tabletoral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year. | Drug | Placebo |
Primary outcome
Frequency of non-viral severe infections
Time frame: Time on the intervention (maximum 1 year)
Infections that lead to hospitalization for >24 hours or lead to death.
6 secondary outcomes
Serious Adverse Events
Time frame: Time on the intervention (maximum 1 year)
Frequency of non-viral infections
Time frame: Time on the intervention (maximum 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.
All cause mortality or hospitalization
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 24098001Danza 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.
- Background: PubMed 14530779Cervera 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.
- Background: PubMed 21532484Barber 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.
- Background: PubMed 24382064Bwakura-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.
- Background: PubMed 21959291Vananuvat 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.
- Individual participant dataSharing planned: No. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer M Cuellar-Rodriguez, MD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trimethoprim-Sulfamethoxazole in people with Lupus Erythematosus, Systemic, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Wisniowski-Yañez, MD (525554870900 ext. 2420, andiewsk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of non-viral severe infections (time frame: Time on the intervention (maximum 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03042260, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.