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NCT07454421: ROISP
Racecadotril for Organ Injury in Sepsis Patients
Phase 1, PHASE2 trial testing Racecadotril in Sepsis in 44 participants. Not yet recruiting.
31 December 2027
Quick facts
| Lead sponsor | Zhujiang Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 1 April 2026 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Racecadotril — full drug profile →
- Water (Placebo) — full drug profile →
Conditions studied
- Sepsis — all drugs for Sepsis →
Sponsor
Zhujiang Hospital
Who can join
Adults 18 to 80, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this single-center, single-blind, randomized, placebo-controlled pilot trial. The effect of Racecadotril on the improvement of organ function will be investigated in patients with sepsis. Researchers will screen patients admitted to the Department of Critical Care Medicine at Zhujiang Hospital to identify patients with sepsis based on including and excluding criteria and obtain informed consent and randomize them into groups. On the basis of standardized treatment for sepsis, the Racecadotril group will be given Racecadotril Granules at a dose of 1.5mg/kg reconstituted in 20ml of water for nasal feeding tube, three times daily; the Control group will be given an 20ml of water for nasal feeding tube,three times daily. The changes in SOFA-2 score and other clinically meaningful outcomes in 4 days will be collected. For subjects whose treatment lasts less than 4 days, the changes on the date of ICU discharge will be used.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07454421
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Racecadotril
Trials testing the same drug.
- NCT07392931 — Safety and Efficacy of Racecadotril in Children With Acute Watery Diarrhea · NA · completed
- NCT06529497 — Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children · Phase 1, PHASE2 · not yet recruiting
- NCT04885049 — Comparing the Efficacy of Anti-secretory Versus Oral Immunoglobulins for Reducing the Episodes of Diarrhea in Children · NA · unknown
- NCT05216822 — Anti-Secretory Drug in Treatment of Acute Watery Diarrhea · Phase 1 · completed
Other recruiting trials for Sepsis
Currently open trials in the same condition.
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- NCT07154615 — Assessing Immune Dysfunction in Sepsis · recruiting
- NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
- NCT07351344 — African Survey on Sepsis Knowledge (ASK) · recruiting
- NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
Other Zhujiang Hospital trials
Trials by the same sponsor.
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- NCT07455175 — Observational Clinical Study on the Association Between Lactate-mediated Gut Microbiota Alterations and Disease Progress · not yet recruiting
- NCT07457099 — Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral a · not yet recruiting
- NCT07455149 — An Observational Clinical Study on the Association of Intestinal Ruminococcus Gnavus and Its Derived Biogenic Amines Wit · not yet recruiting
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 NCT07454421 (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 Zhujiang Hospital
- Last refreshed: 6 March 2026
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