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NCT04219735
Effect of Minocycline on Delirium Incidence in Critically Ill Patients
Phase 2 trial testing Minocycline in Delirium in 160 participants. Completed in 30 November 2021.
30 November 2021
Quick facts
| Lead sponsor | Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 160 |
| Start date | 30 January 2020 |
| Primary completion | 30 November 2021 |
| Estimated completion | 30 November 2021 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Minocycline (MINOCYCLINE) — full drug profile →
- Placebos — full drug profile →
Conditions studied
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude — full company profile →
Who can join
18 and older, any sex, with Delirium or Coma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Delirium is a disorder of consciousness characterized by an acute onset and fluctuating course of impaired cognitive functioning. It is associated with unfavorable outcomes in hospitalized patients, including longer hospital length of stay, need for subsequent institutionalization and higher mortality rates. Patients in the intensive care unit (ICU) under mechanical ventilation and older age are at higher risk for the development of delirium. Several studies suggest that minocycline, through its anti-inflammatory effect, was able to prevent neuronal dysfunction in different models of ICU-related diseases. Thus, the present study aimed to evaluate the effect of minocycline on delirium development in critically ill patients. Patients will be randomized into one of two groups: the intervention group that will receive 100mg of minocycline 2 times a day and the placebo group. Medication or placebo will be continued for 28 days or until ICU discharge (whichever occurs first). Delirium will be diagnosed by the CAM-ICU. Coma will be defined by the Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 and biomarkers will be used as alternative outcomes related to the pathophysiology of the disease (IL-1, IL-6, IL-10, and BDNF).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prophylactic Minocycline for Delirium in Critically Ill Patients: A Randomized Controlled Trial.
Dal-Pizzol F, Coelho A, Simon CS, Michels M, et al · · 2024 · cited 14× · PMID 38043911 · DOI 10.1016/j.chest.2023.11.041
Verify or expand the search:
- PubMed search for NCT04219735
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Delirium
Currently open trials in the same condition.
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- NCT07369258 — Clinical Application of Listening to Music to Prevent Delirium in the Intensive Care Unit · NA · recruiting
- NCT07488468 — Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures · recruiting
- NCT07136207 — Development and Validation of Delirium Recognition Using Computer Vision in Neuro-critical Patients · recruiting
Other Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude trials
Trials by the same sponsor.
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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 NCT04219735 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Last refreshed: 31 May 2022
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/NCT04219735.
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