Treatment of Survivors After Botulism Outbreak - Full Text View

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:

MedlinePlus related topics: Botulism Respiratory Failure

U.S. FDA Resources

Further study details as provided by Rajavithi Hospital:

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

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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.

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.

Fernandez 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.

Zanon P, Pattis P, Pittscheider W, Roscia G, De Giorgi G, Sacco G, Votter 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.

Jones RG, Corbel MJ, Sesardic D. A review of WHO International Standards for botulinum antitoxins. Biologicals. 2006 Feb 17; [Epub ahead of print]

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

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.

ClinicalTrials.gov Identifier:	NCT00314080 History of Changes
Other Study ID Numbers:	RVH_CER_001
Study First Received:	March 30, 2006
Last Updated:	October 23, 2008
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by Rajavithi Hospital:

Botulism
Botulinum anti-toxin
Repetitive nerve stimulation
Respiratory failure

Additional relevant MeSH terms:

Botulism
Respiratory Insufficiency
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Junction Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurotoxicity Syndromes
Foodborne Diseases

Poisoning
Substance-Related Disorders
Respiration Disorders
Respiratory Tract Diseases
Antitoxins
Botulinum Antitoxin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013