MedDataX Logo

Botulism Outbreak in Thailand (Episode II)

NCT ID: NCT00348426

Last Updated: 2006-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRELIMINARY REPORT Northern Thailand's big botulism outbreak occurred again on 30 June 14, 2006, \[16.00pm\] affecting 83 from 192 people who exposed to raw dear meat and gut \[1 night preserved with ice pack of whole body of dear before disection and distribution \]. Of these, 3 developed respiratory failure, 1 developed impending respiratory failure, 83 of 192 whom developed fatique and diarrhea after ingestion of raw dear meat and gut on 26-30 June 2006. 3 patients were refered to 2 high facility hospitals for severe respiratory failure. Physical examination of 3 patients in ICU of Chiang Kum general hospital revealed ptosis \[3/3\] mild ophthalmoparesis \[2/3\] Proximal muscle weakness \[2/3\] abdominal paradoxical respiration \[3/3\] pupil dilate \[1/3\] and negative inspiratory pressure \[NIP\] less than 15 mmHg \[3/3\] were observed. Neurological electrophysiologic study of 2 patients revealed low amplitude compound muscle action potential \[CMAP\] of Abductor digiti minimi \[ADM\] muscle with decrement response after repetitive stimulation with low frequency \[3Hz\], increment response of ADM muscle after stimulation with high frequency \[10Hz, 20Hz, and 30Hz.\].The electrophysiologic findings support diagnosis of presynaptic neuromuscular dysfunction with respiratory failure, Botulism is most likely diagnosis. After treated with botulinum antitoxin \[on July,1 ,2006 \[mixed-type botulinum antitoxin --donated from Japan at Nan Hospital's botulisum outbreak on March 14,2006\], 3 patients in ICU showed improvement of over all clinical outcomes. Active survey by Ministry of Public Health of Thailand and CDC-USA to identify the high risk patient who may develop respiratory failure , and immunologucal vs microbiological diagnosis were performed. This outbreak may be the second hit of botulisum in the northern Thailand but less amount of severe cases was observed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Botulism

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Food Borne Botulism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Botulinum AntiToxin

Intervention Type DRUG

neuro-electrophysiologic study, repetitive nerve stimulation

Intervention Type PROCEDURE

: Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rajavithi Biomolecular Research Center

OTHER

Sponsor Role collaborator

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Subsai Kongsaengdao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Services Ministry of Public Health of Thailand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chiang Kum Hospital

Payao, Payao, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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/)

Reference Type 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)

Reference Type 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.

Reference Type BACKGROUND
PMID: 11075968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10427033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16490362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15498163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16256299 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16163636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15847370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17051488 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RVH_CER_002

Identifier Type: -

Identifier Source: org_study_id