Last reviewed · How we verify
NCT06953154: MDW
Monocyte Distribution Width (MDW): An Early Marker of Sepsis in Patients With Comorbidities
trial testing monocyte distribution width in Sepsis in 325 participants. Completed in 30 June 2025.
30 June 2025
Quick facts
| Lead sponsor | Hôpital Universitaire Sahloul |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 325 |
| Start date | 1 December 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across Tunisia |
Drugs / interventions tested
- monocyte distribution width
Conditions studied
- Sepsis — all drugs for Sepsis →
Sponsor
Hôpital Universitaire Sahloul — full company profile →
Who can join
18 and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In patients with the aforementioned comorbidities, septic conditions are common and associated with high mortality rates. Early diagnosis, along with prompt and appropriate management, has become a major challenge for emergency departments. However, it is often difficult to determine whether sepsis is the primary factor behind clinical decompensation, especially in patients with complex comorbidities where symptoms may be nonspecific and overlap with other causes of deterioration. This diagnostic uncertainty complicates the timely initiation of targeted treatment, making the role of biomarkers even more crucial. The measurement of sepsis biomarkers is widely used in clinical practice to enhance diagnostic accuracy, but there remains a need for a more reliable biomarker. A biomarker with higher sensitivity and negative predictive value (NPV) is essential for the early initiation of treatment. Several European and American studies have demonstrated the added value of MDW as an early predictor of sepsis in patients admitted to intensive care units, as well as its diagnostic performance when combined with the qSOFA score. In the literature, the MDW threshold is established at 21.5, offering optimal diagnostic power with good sensitivity and specificity, supporting its clinical application and its approval by the United States Food and Drug Administration (FDA) and the European Conformity (CE). In Tunisia, few studies have focused on the effectiveness of this non-invasive tool in septic patients in emergency settings and its reliability in this context, highlighting the relevance of our research.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06953154
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sepsis
Currently open trials in the same condition.
- NCT07507877 — Infraclavicular Axillary Vein Collapsibility Index as a Predictor of Fluid Responsiveness · recruiting
- 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 Hôpital Universitaire Sahloul trials
Trials by the same sponsor.
- NCT07329881 — Artificial Intelligence Algorithm for the Interpretation of Traumatic Bone Radiographs · active not recruiting
- NCT07147699 — Evaluation of the Effectiveness of the CardioStory Device in Distinguishing Heart Failure From Other Causes in Patients · not yet recruiting
- NCT07089277 — External Validation of the Glasgow-Blatchford Bleeding Score in a Tunisian Population · recruiting
- NCT05646433 — Validation of a New Score for UGI Bleeding in the ED: the Study of the TU-GIB Score · unknown
- NCT05670444 — Melatonin, Vitamins and Minerals Supplements for the Treatment of Covid-19 and Covid-like Illness · Phase 1 · completed
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 NCT06953154 (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 Hôpital Universitaire Sahloul
- Last refreshed: 21 August 2025
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/NCT06953154.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing