BotulismNCT00348426
Botulism Outbreak in Thailand (Episode II)
An observational study of Botulism, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Botulism
- What is being tested?
- Botulinum AntiToxin, neuro-electrophysiologic study, repetitive nerve stimulation and : Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2006to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who did not eat deer meat and or the gut from Chiang Kum district
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Manifestations of Botulism Outbreak in Northern Thailand: A Case Series of Botulism Treated With Botulinum Anti-Toxin.
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.
Read the detailed description
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
- Botulism
- Being tested
- Botulinum AntiToxin, neuro-electrophysiologic study, repetitive nerve stimulation, : Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure
- Keywords
- Food Borne Botulism
- Medical subject headings
- Botulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum AntiToxinDrug
neuro-electrophysiologic study, repetitive nerve stimulationProcedure or surgery
: Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for BotulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Collaborators
- Rajavithi Biomolecular Research Center
- Investigators
- Subsai Kongsaengdao, M.D., Principal investigator, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348426
- Sponsor's protocol ID
- RVH_CER_002
- Status last verified
- Nov 2006
- First submitted
- 2 Jul 2006
- Last updated
- 8 Nov 2006
- Results posted
- No
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 11075968Fernandez 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 10427033Jones 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 16490362Sobel 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 15498163Boyadjiev 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 16256299Sobel J. Botulism. Clin Infect Dis. 2005 Oct 15;41(8):1167-73. doi: 10.1086/444507. Epub 2005 Aug 29.
PubMed 16163636Agarwal 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 15847370Kongsaengdao 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Manifestations of Botulism Outbreak in Northern Thailand: A Case Series of Botulism Treated With Botulinum Anti-Toxin.
- ClinicalTrials.gov ID
- NCT00348426
- Acronym / sponsor ID
- RVH_CER_002
- Conditions
- Botulism
- Keywords
- Food Borne Botulism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Collaborators
- Rajavithi Biomolecular Research Center
- Study start
- Jun 2006
- Study completion
- Sep 2006
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who did not eat deer meat and or the gut from Chiang Kum district
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum AntiToxin | Drug | – |
| neuro-electrophysiologic study, repetitive nerve stimulation | Procedure or surgery | – |
| : Protocol early weaning ventilator after recovery of repetitive nerve stimulation and stable negative inspiratory pressure | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2006.
- BackgroundWorld 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/)
- BackgroundP 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: PubMed 11075968Swaddiwudhipong 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.
- Background: PubMed 10427033Fernandez 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.
- Background: PubMed 16490362Jones 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.
- Background: PubMed 15498163Sobel 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.
- Background: PubMed 16256299Boyadjiev 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.
- Background: PubMed 16163636Sobel J. Botulism. Clin Infect Dis. 2005 Oct 15;41(8):1167-73. doi: 10.1086/444507. Epub 2005 Aug 29.
- Background: PubMed 15847370Agarwal AK, Goel A, Kohli A, Rohtagi A, Kumar R. Food-borne botulism. J Assoc Physicians India. 2004 Aug;52:677-8. No abstract available.
- Background: PubMed 17051488Kongsaengdao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subsai Kongsaengdao, M.D. principal investigator
Department of Medical Services Ministry of Public Health of Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Botulism, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00348426, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2006.