Botulism Outbreak in Thailand (Episode II)

Botulism Clinical Trial

Official title:

Clinical Manifestations of Botulism Outbreak in Northern Thailand: A Case Series of Botulism Treated With Botulinum Anti-Toxin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348426
• Other study ID #: RVH_CER_002
• Status: Completed
• Phase: Phase 4
• First received: July 2, 2006
• Last updated: November 7, 2006
• Start date: June 2006
• Est. completion date: September 2006

Study information

• Verified date: November 2006
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Botulism

Intervention

Drug:
• Botulinum AntiToxin

Procedure:
• neuro-electrophysiologic study, repetitive nerve stimulation

• : Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure

Locations

Country	Name	City	State
Thailand	Chiang Kum Hospital	Payao

Sponsors (2)

Lead Sponsor	Collaborator
Rajavithi Hospital	Rajavithi Biomolecular Research Center

Country where clinical trial is conducted

Thailand, 

References & Publications (10)

Agarwal AK, Goel A, Kohli A, Rohtagi A, Kumar R. Food-borne botulism. J Assoc Physicians India. 2004 Aug;52:677-8. — View Citation

Boyadjiev I, Leone M, Garnier F, Thomachot L, Martin C. [A case of type A botulism]. Ann Fr Anesth Reanim. 2005 Nov-Dec;24(11-12):1397-9. Epub 2005 Oct 26. French. — View Citation

Fernández PS, Peck MW. A predictive model that describes the effect of prolonged heating at 70 to 90 degrees C and subsequent incubation at refrigeration temperatures on growth from spores and toxigenesis by nonproteolytic Clostridium botulinum in the presence of lysozyme. Appl Environ Microbiol. 1999 Aug;65(8):3449-57. — View Citation

Jones RG, Corbel MJ, Sesardic D. A review of WHO International Standards for botulinum antitoxins. Biologicals. 2006 Sep;34(3):223-6. Epub 2006 Feb 20. Review. — View Citation

Kongsaengdao S, Samintarapanya K, Rusmeechan S, Wongsa A, Pothirat C, Permpikul C, Pongpakdee S, Puavilai W, Kateruttanakul P, Phengtham U, Panjapornpon K, Janma J, Piyavechviratana K, Sithinamsuwan P, Deesomchok A, Tongyoo S, Vilaichone W, Boonyapisit K, Mayotarn S, Piya-Isragul B, Rattanaphon A, Intalapaporn P, Dusitanond P, Harnsomburana P, Laowittawas W, Chairangsaris P, Suwantamee J, Wongmek W, Ratanarat R, Poompichate A, Panyadilok H, Sutcharitchan N, Chuesuwan A, Oranrigsupau P, Sutthapas C, Tanprawate S, Lorsuwansiri J, Phattana N; Thai Botulism Study Group. An outbreak of botulism in Thailand: clinical manifestations and management of severe respiratory failure. Clin Infect Dis. 2006 Nov 15;43(10):1247-56. Epub 2006 Oct 16. Review. — View Citation

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)

Sobel J, Tucker N, Sulka A, McLaughlin J, Maslanka S. Foodborne botulism in the United States, 1990-2000. Emerg Infect Dis. 2004 Sep;10(9):1606-11. — View Citation

Sobel J. Botulism. Clin Infect Dis. 2005 Oct 15;41(8):1167-73. Epub 2005 Aug 29. Review. — View Citation

Swaddiwudhipong W, Wongwatcharapaiboon P. Foodborne botulism outbreaks following consumption of home-canned bamboo shoots in Northern Thailand. J Med Assoc Thai. 2000 Sep;83(9):1021-5. — View Citation

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/)