Botulism Outbreak in Thailand (Episode II)

This study has been completed.
Sponsor:
Collaborator:
Rajavithi Biomolecular Research Center
Information provided by:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT00348426
First received: July 2, 2006
Last updated: November 7, 2006
Last verified: November 2006
  Purpose

A second botulism outbreak in Northern Thailand was reported in 2006. 192 people were exposed to raw meat and the gut of deer, 83 suffered from diarrhea. Of these 5 developed respiratory failure, 1 impending respiratory failure.

We analysed the clinical findings and electrophysiologic findings in this second episode of large botulism outbreak in northern Thailand.


Condition Intervention Phase
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
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Clinical Manifestations of Botulism Outbreak in Northern Thailand: A Case Series of Botulism Treated With Botulinum Anti-Toxin.

Resource links provided by NLM:


Further study details as provided by Rajavithi Hospital:

Estimated Enrollment: 200
Study Start Date: June 2006
Estimated Study Completion Date: September 2006
Detailed Description:

PRELIMINARY REPORT Northern Thailand's big botulism outbreak occurred again on 30 June 14, 2006, [16.00pm] affecting 83 from 192 people who exposed to raw dear meat and gut [1 night preserved with ice pack of whole body of dear before disection and distribution ]. Of these, 3 developed respiratory failure, 1 developed impending respiratory failure, 83 of 192 whom developed fatique and diarrhea after ingestion of raw dear meat and gut on 26-30 June 2006. 3 patients were refered to 2 high facility hospitals for severe respiratory failure. Physical examination of 3 patients in ICU of Chiang Kum general hospital revealed ptosis [3/3] mild ophthalmoparesis [2/3] Proximal muscle weakness [2/3] abdominal paradoxical respiration [3/3] pupil dilate [1/3] and negative inspiratory pressure [NIP] less than 15 mmHg [3/3] were observed. Neurological electrophysiologic study of 2 patients revealed low amplitude compound muscle action potential [CMAP] of Abductor digiti minimi [ADM] muscle with decrement response after repetitive stimulation with low frequency [3Hz], increment response of ADM muscle after stimulation with high frequency [10Hz, 20Hz, and 30Hz.].The electrophysiologic findings support diagnosis of presynaptic neuromuscular dysfunction with respiratory failure, Botulism is most likely diagnosis. After treated with botulinum antitoxin [on July,1 ,2006 [mixed-type botulinum antitoxin --donated from Japan at Nan Hospital's botulisum outbreak on March 14,2006], 3 patients in ICU showed improvement of over all clinical outcomes. Active survey by Ministry of Public Health of Thailand and CDC-USA to identify the high risk patient who may develop respiratory failure , and immunologucal vs microbiological diagnosis were performed. This outbreak may be the second hit of botulisum in the northern Thailand but less amount of severe cases was observed.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ate the deer meat and/or the gut from Chiang Kum district, after June 26,2006
  • Clinical botulism or respiratory failure who need ventilator assistance
  • The staff of referring hospital willing to participate in the Thai Botulism study group

Exclusion Criteria:

• Patients who did not eat deer meat and or the gut from Chiang Kum district

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00348426

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

Publications:
Agarwal AK, Goel A, Kohli AFood-borne botulism. J Assoc Physicians India. 2004 Aug;52:677-8.

ClinicalTrials.gov Identifier: NCT00348426     History of Changes
Other Study ID Numbers: RVH_CER_002
Study First Received: July 2, 2006
Last Updated: November 7, 2006
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Rajavithi Hospital:
Food Borne Botulism

Additional relevant MeSH terms:
Botulism
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Junction Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurotoxicity Syndromes
Foodborne Diseases
Poisoning
Substance-Related Disorders
Antitoxins
Botulinum Antitoxin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014