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NCT03042260
Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial
Phase 4 trial testing Trimethoprim-Sulfamethoxazole in Lupus Erythematosus, Systemic in 310 participants. Status unknown.
1 February 2021
Quick facts
| Lead sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 310 |
| Start date | 1 March 2017 |
| Primary completion | 1 February 2021 |
| Estimated completion | 1 August 2021 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Trimethoprim-Sulfamethoxazole
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — full company profile →
Who can join
18 and older, any sex, with Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03042260
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Lupus Erythematosus, Systemic
Currently open trials in the same condition.
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- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. · recruiting
- NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I · Phase 2 · recruiting
- NCT06881290 — Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus · Phase 1 · recruiting
Other Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran trials
Trials by the same sponsor.
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- NCT07507981 — Effects of Exercise in Hemodialysis · NA · completed
- NCT06953193 — Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03042260 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Last refreshed: 25 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03042260.
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