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Treatment of Survivors After Botulism Outbreak

Primary Purpose

Respiratory Failure, Botulism

Status
Completed
Phase
Locations
Thailand
Study Type
Observational
Intervention
Botulinum AntiToxin
neuro-electrophysiologic study, repetitive nerve stimulation
Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Respiratory Failure focused on measuring Botulism, Botulinum anti-toxin, Repetitive nerve stimulation, Respiratory failure

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rajavithi Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 30, 2006
Last Updated
October 23, 2008
Sponsor
Rajavithi Hospital
Collaborators
Rajavithi Biomolecular Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00314080
Brief Title
Treatment of Survivors After Botulism Outbreak
Official Title
An Outbreak of Botulism in Thailand: Clinical Manifestations and Management of Severe Respiratory Failure
Study Type
Observational

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rajavithi Hospital
Collaborators
Rajavithi Biomolecular Research Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Botulism
Keywords
Botulism, Botulinum anti-toxin, Repetitive nerve stimulation, Respiratory failure

7. Study Design

Enrollment
18 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Botulinum AntiToxin
Intervention Type
Procedure
Intervention Name(s)
neuro-electrophysiologic study, repetitive nerve stimulation
Intervention Type
Procedure
Intervention Name(s)
Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subsai Kongsaengdao, M.D.
Organizational Affiliation
Rajavithi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
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/)
Results Reference
background
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)
Results Reference
background
PubMed Identifier
11075968
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.
Results Reference
background
PubMed Identifier
10427033
Citation
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. doi: 10.1128/AEM.65.8.3449-3457.1999.
Results Reference
background
PubMed Identifier
16557441
Citation
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. doi: 10.1055/s-2006-924967.
Results Reference
background
PubMed Identifier
16490362
Citation
Jones RG, Corbel MJ, Sesardic D. A review of WHO International Standards for botulinum antitoxins. Biologicals. 2006 Sep;34(3):223-6. doi: 10.1016/j.biologicals.2005.11.009. Epub 2006 Feb 20.
Results Reference
background
PubMed Identifier
16256299
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. doi: 10.1016/j.annfar.2005.06.002. Epub 2005 Oct 26. French.
Results Reference
background
PubMed Identifier
16163636
Citation
Sobel J. Botulism. Clin Infect Dis. 2005 Oct 15;41(8):1167-73. doi: 10.1086/444507. Epub 2005 Aug 29.
Results Reference
background
PubMed Identifier
15847370
Citation
Agarwal AK, Goel A, Kohli A, Rohtagi A, Kumar R. Food-borne botulism. J Assoc Physicians India. 2004 Aug;52:677-8. No abstract available.
Results Reference
background
PubMed Identifier
15498163
Citation
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. doi: 10.3201/eid1009.030745.
Results Reference
background
PubMed Identifier
17051488
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. doi: 10.1086/508176. Epub 2006 Oct 16.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17051488&query_hl=1&itool=pubmed_docsum
Description
Pubmed

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Treatment of Survivors After Botulism Outbreak

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