ClinicalTrials.gg
CompletedNCT00314080Updated Oct 24, 2008

Treatment of Survivors After Botulism Outbreak

An observational study in Respiratory Failure and Botulism, sponsored by Rajavithi Hospital. Completed at 1 site in Thailand. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2008-10-24.

Sponsored by Rajavithi Hospital · Observational

Study type
Observational
Enrollment
18
Ages
1 Year and older
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Failure
  • Botulism

Keywords

  • Botulism
  • Botulinum anti-toxin
  • Repetitive nerve stimulation
  • Respiratory failure
03

In context

Respiratory Insufficiency

1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.

This study's enrollment of 18 is below the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Rajavithi Hospital is the lead sponsor of 46 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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.
05

Study design

Enrollment
18 participants

Interventions

  • DrugBotulinum AntiToxin
  • Procedureneuro-electrophysiologic study, repetitive nerve stimulation
  • ProcedureProtocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure
06

Study locations

1 site
  • Rajavithi Hospital
    Bangkok, 10400, Thailand
07

References and documents

Publications

  • 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/)
  • 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)
  • 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. PubMed 11075968 ↗
  • 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. PubMed 10427033 ↗
  • 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. PubMed 16557441 ↗
  • 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. PubMed 16490362 ↗
  • 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. PubMed 16256299 ↗
  • Sobel J. Botulism. Clin Infect Dis. 2005 Oct 15;41(8):1167-73. doi: 10.1086/444507. Epub 2005 Aug 29. PubMed 16163636 ↗
  • 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. PubMed 15847370 ↗
  • 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. PubMed 15498163 ↗
  • 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. PubMed 17051488 ↗

Related links

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2006 and a completion of Apr 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2006
First posted
Apr 12, 2006
Start
Mar 2006
Completion
Apr 2006
Last update
Oct 24, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Oct 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00314080
Lead sponsor
Rajavithi Hospital
Collaborators
Rajavithi Biomolecular Research Center
First posted
Apr 12, 2006
Start date
Mar 2006
Completion
Apr 2006
Last update
Oct 24, 2008

Study contacts

Subsai Kongsaengdao, M.D.
principal investigator · Rajavithi Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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