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Botulism Outbreak in Thailand (Episode II)

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ClinicalTrials.gov Identifier: NCT00348426
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : November 8, 2006
Sponsor:
Collaborator:
Rajavithi Biomolecular Research Center
Information provided by:
Rajavithi Hospital

Brief Summary:

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 or disease Intervention/treatment
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

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.

Study Type : Observational
Enrollment : 200 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Clinical Manifestations of Botulism Outbreak in Northern Thailand: A Case Series of Botulism Treated With Botulinum Anti-Toxin.
Study Start Date : June 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botulism
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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


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): 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

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: NCT00348426     History of Changes
Other Study ID Numbers: RVH_CER_002
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: November 8, 2006
Last Verified: November 2006

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
Chemically-Induced Disorders
Antitoxins
Botulinum Antitoxin
Immunologic Factors
Physiological Effects of Drugs