NCT02570971

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

2.7 years

First QC Date

October 6, 2015

Last Update Submit

October 6, 2015

Conditions

Ciguatoxin

Keywords

mannitoltreatment

Outcome Measures

Primary Outcomes (1)

  • Symptom score

    Covers a variety of neurological and gastrointestinal symptoms on a 0-4 score

    24 hours

Study Arms (2)

Control

NO INTERVENTION

Patients will receive supportive care measures.

Investigational

EXPERIMENTAL

Patients will receive 500mL of 20% mannitol

Drug: Mannitol

Interventions

MannitolDRUG
Investigational

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History consistent with ciguatera poisoning

You may not qualify if:

  • Minors
  • pregnant patients
  • those unable to give consent
  • severe congestive heart failure or renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Mannitol

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Central Study Contacts

Michael Butterfield, MD MS MPH

CONTACT

mbutterfield@health.usf.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 7, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2018

Last Updated

October 7, 2015

Record last verified: 2015-10