NCT00348426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

November 8, 2006

Status Verified

November 1, 2006

First QC Date

July 2, 2006

Last Update Submit

November 7, 2006

Conditions

Keywords

Food Borne Botulism

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who did not eat deer meat and or the gut from Chiang Kum district

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiang Kum Hospital

Payao, Payao, Thailand

Location

Related Publications (10)

  • 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/)

    BACKGROUND
  • 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)

    BACKGROUND
  • 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.

    PMID: 11075968BACKGROUND
  • 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.

    PMID: 10427033BACKGROUND
  • 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.

    PMID: 16490362BACKGROUND
  • 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.

    PMID: 15498163BACKGROUND
  • 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.

    PMID: 16256299BACKGROUND
  • Sobel J. Botulism. Clin Infect Dis. 2005 Oct 15;41(8):1167-73. doi: 10.1086/444507. Epub 2005 Aug 29.

    PMID: 16163636BACKGROUND
  • 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.

    PMID: 15847370BACKGROUND
  • 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.

    PMID: 17051488BACKGROUND

MeSH Terms

Conditions

Botulism

Interventions

Botulinum Antitoxin

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsNeuromuscular Junction DiseasesNeuromuscular DiseasesNervous System DiseasesNeurotoxicity SyndromesFoodborne DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

AntitoxinsImmune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex Mixtures

Study Officials

  • Subsai Kongsaengdao, M.D.

    Department of Medical Services Ministry of Public Health of Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 2, 2006

First Posted

July 4, 2006

Study Start

June 1, 2006

Study Completion

September 1, 2006

Last Updated

November 8, 2006

Record last verified: 2006-11

Locations