A Phase 3 interventional study of Mannitol in Ciguatoxin, sponsored by University of South Florida. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2015-10-07.
Sponsored by University of South Florida · Phase 3, Interventional, and Treatment
Ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global public health concern. In the US, the vast majority of ciguatera poisonings occur in Florida, followed by Hawaii and California. Equipoise exists in the medical literature regarding the effectiveness of mannitol therapy in treatment of ciguatera poisoning. While there are many case reports attesting to its utility, the only randomized control trial (RCT) comparing mannitol therapy with supportive care failed to show any significant benefit from mannitol treatment for a variety of clinical outcomes. Investigators therefore propose a second, larger RCT to test this question.
University of South Florida is the lead sponsor of 338 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Exclusion Criteria:
Patients will receive supportive care measures.
Patients will receive 500mL of 20% mannitol
Drug: Mannitol
Symptom score
Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score
Time frame: 24 hours
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mannitol