Treatment of Survivors After Botulism Outbreak

Respiratory Failure Clinical Trial

Official title:

An Outbreak of Botulism in Thailand: Clinical Manifestations and Management of Severe Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314080
• Other study ID #: RVH_CER_001
• Status: Completed
• Phase: N/A
• First received: March 30, 2006
• Last updated: October 23, 2008
• Start date: March 2006
• Est. completion date: April 2006

Study information

• Verified date: August 2007
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Botulism
• Respiratory Failure
• Respiratory Insufficiency

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	Rajavithi Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Rajavithi Hospital	Rajavithi Biomolecular Research Center

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

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, — 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/)

Zanon P, Pattis P, Pittscheider W, Roscia G, De Giorgi G, Sacco G, Vötter K, Stockner I, De Giorgi F, Wiedermann CJ. Two cases of foodborne botulism with home-preserved asparagus. Anasthesiol Intensivmed Notfallmed Schmerzther. 2006 Mar;41(3):156-9. — View Citation

* Note: There are 11 references in all — Click here to view all references

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