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Treatment of Survivors After Botulism Outbreak

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314080
First Posted: April 12, 2006
Last Update Posted: October 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rajavithi Biomolecular Research Center
Information provided by:
Rajavithi Hospital
  Purpose

Background. Northern Thailand's 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.


Condition Intervention
Respiratory Failure Botulism Drug: Botulinum AntiToxin Procedure: neuro-electrophysiologic study, repetitive nerve stimulation Procedure: Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure

Study Type: Observational
Official Title: An Outbreak of Botulism in Thailand: Clinical Manifestations and Management of Severe Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Rajavithi Hospital:

Estimated Enrollment: 18
Study Start Date: March 2006
Estimated Study Completion Date: April 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusions:

  • Ate the bamboo shoots in Banluang district, on March,14 2006
  • Clinical of respiratory failure and need ventilator assistant
  • Needed to referred to other hospital
  • The staffs of referred hospital willing to participate in the Thai Botulism study group

Exclusion Criteria:

  • Patients who did not eat bamboo shoots in Banluang district on March14,2006.
  • No clinical of respiratory failure.
  • Not referred to other hospital.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314080


Locations
Thailand
Rajavithi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
Rajavithi Biomolecular Research Center
Investigators
Principal Investigator: Subsai Kongsaengdao, M.D. Rajavithi Hospital
  More Information

Additional Information:
Pubmed  This link exits the ClinicalTrials.gov site

Publications:
World Health Organization .Botulism in Thailand: Epidemic and Pandemic Alert and Response (EPR). (Accessed March 22, 2006, at http://www.who.int/csr/don/2005_12_22/en/)
P Wongwatcharapaiboon, L Thaikruea, and K Ungchusak et. al. Foodborne Botulism Associated With Home-Canned Bamboo Shoots,Thailand, 1998. ). (Accessed March 22, 2006, at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4821a1.htm)

ClinicalTrials.gov Identifier: NCT00314080     History of Changes
Other Study ID Numbers: RVH_CER_001
First Submitted: March 30, 2006
First Posted: April 12, 2006
Last Update Posted: October 24, 2008
Last Verified: August 2007

Keywords provided by Rajavithi Hospital:
Botulism
Botulinum anti-toxin
Repetitive nerve stimulation
Respiratory failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Botulism
Respiration Disorders
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Junction Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurotoxicity Syndromes
Foodborne Diseases
Poisoning
Chemically-Induced Disorders
Antitoxins
Botulinum Antitoxin
Immunologic Factors
Physiological Effects of Drugs