Viewing Study NCT00314080



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Study NCT ID: NCT00314080
Status: COMPLETED
Last Update Posted: 2008-10-24
First Post: 2006-03-30

Brief Title: Treatment of Survivors After Botulism Outbreak
Sponsor: Rajavithi Hospital
Organization: Rajavithi Hospital

Study Overview

Official Title: An Outbreak of Botulism in Thailand Clinical Manifestations and Management of Severe Respiratory Failure
Status: COMPLETED
Status Verified Date: 2007-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Background Northern Thailands biggest botulism outbreak to date occurred on 14 March 2006 and affected 209 people Of these 42 developed respiratory failure and 25 of those who developed respiratory failure were referred to 9 high facility hospitals for treatment of severe respiratory failure and autonomic nervous system involvement Among these patients we aimed to assess the relationship between the rate of ventilator dependence and the occurrence of treatment by day 4 versus day 6 after exposure to bamboo shoots the source of the botulism outbreak as well as the relationship between ventilator dependence and negative inspiratory pressure

Methods The investigators reviewed the circumstances and timing of symptoms following exposure Mobile teams treated patients with botulinum antitoxin on day 4 or day 6 after exposure in Nan Hospital Nan Thailand Eighteen patients in 7 high facility hospitals with severe respiratory failure received a low- and high-rate repetitive nerve stimulation test and negative inspiratory pressure was measured
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None