Botulism; PoisoningBotuREANCT03658902
Retrospective Epidemiological Study on Botulism in Intensive Care Units in France
An observational study of Botulism; Poisoning, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
Botulism poisoning is a rare but serious illness. Because of it's low incidence, it is not well known by physicians. Most studies describing botulism date back to the last century and do not take into account recent advances in intensive care. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Botulism; Poisoning
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2000to 15 Aug 2018
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: All patients 15 years of age or older with a clinical diagnosis of botulism.
Who may be able to join
- Clinical diagnosis of botulism
- Admission in an intensive care or high dependancy unit
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Epidemiological Study on Patients Admitted for Botulism Poisoning in Intensive Care Units in France
Botulism poisoning is a rare but serious illness. Because of it's low incidence, it is not well known by physicians. Most studies describing botulism date back to the last century and do not take into account recent advances in intensive care.
The objective of this study is to describe the clinical course, interventions and outcomes of patients with severe botulism poisoning requiring a hospitalisation in an intensive care or high dependancy unit.
- Conditions
- Botulism; Poisoning
- Keywords
- Botulism, Intensive Care
- Medical subject headings
- Botulism, Poisoning
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Proportion of patients alive at ICU discharge
Measured: 2000 to 2017
Secondary outcomes (31)
Age
Mean age of recruited patients
Measured: 2000 to 2017
Weight
Mean weight of recruited patients
Measured: 2000 to 2017
Height
Mean Height of recruited patients
Measured: 2000 to 2017
History of motor impairment measured by the modified Rankin scale
History of neurological disorder with motor impairment before the poisoning, measured by the Modified Rankin Scale (0 to 6, 0 being no symptoms and 6 being deceased).
Measured: 2000 to 2017
History of heart failure measured by the NYHA (New York Health Association) score
History of heart failure before the poisoning, measured by the NYHA (New York health Association) dyspnoea score (1 to 4, 1 being no symptoms and no limitation in daily physical activity, 4 being severe symptoms even at rest).
Measured: 2000 to 2017
History of chronic respiratory failure: use of daily oxygen therapy AND/OR non invasive ventilation
Chronic respiratory failure defined by the use of chronic oxygen therapy AND/OR daily non invasive ventilation.
Measured: 2000 to 2017
History of chronic kidney disease measured by the glomerular filtration rate.
History of chronic kidney disease before the poisoning, defined as a glomerular filtration rate < 60 mL/min/1.73m for more than 3 months OR chronic dialysis.
Measured: 2000 to 2017
History of cirrhosis as measured by the CHILD-PUGH score.
Presence or absence of Cirrhosis, as measured by the CHILD-PUGH score (class A, B or C, A predicting a one year survival probability of 100%, C predicting a one year survival probability of 45%).
Measured: 2000 to 2017
Source of the contamination
Suspected origin of the toxin: food poisoning, dermal wound, intravenous drug use, intestinal colonisation by Clostridium sp. or unknown.
Measured: 2000 to 2017
Isolated or multiple cases
Whether the poisoning is isolated or one of multiple cases originating from the same source.
Measured: 2000 to 2017
Botulinum Toxin type if identified
Botulinum toxin type if identified (A,B,C,D,E,F,G or H type toxin).
Measured: 2000 to 2017
Severity at ICU admission
Simplified acute physiology score 2 (SAPS 2) at admission in the ICU: from 0 to 163, with 0 predicting a mortality risk of 0% and 163 of 100%.
Measured: 2000 to 2017
Mechanical ventilation requirement
Whether the patient required or not mechanical ventilation during his ICU stay
Measured: 2000 to 2017
Invasive mechanical ventilation requirement
Whether the patient required or not invasive mechanical ventilation during his ICU stay
Measured: 2000 to 2017
Non invasive mechanical ventilation requirement
Whether the patient required or not non invasive mechanical ventilation during his ICU stay
Measured: 2000 to 2017
Whether or not the patient required a tracheotomy during his ICU stay.
Whether the patient required a tracheotomy during his ICU stay
Measured: 2000 to 2017
Enteral or parenteral nutritional support
Whether the patient required or not enteral or parenteral nutritional support during his ICU stay
Measured: 2000 to 2017
Number of days of vasopressor support
Number of days the patient required vasopressor support during his ICU stay
Measured: 2000 to 2017
Acute kidney injury measured by maximum serum creatinine during ICU stay.
Whether the patient developped an acute kidney injury during his ICU stay: measured by maximum serum creatinine during ICU stay in µmol/L.
Measured: 2000 to 2017
Severe liver failure
Whether the patient developped an acute severe liver failure during his ICU stay, defined as a prothrombin time less than 50% due to liver failure.
Measured: 2000 to 2017
Whether or not antitoxin was administered to the patient.
Whether botulinum antitoxin was administered.
Measured: 2000 to 2017
Whether or not guanidine was administered during ICU stay
Whether guanidine was administered as a treatment for the botulinum poisoning.
Measured: 2000 to 2017
Length of stay.
Number of hospitalisation days in the ICU.
Measured: 2000 to 2017
Healthcare acquired infection
Whether the patient acquired a healthcare related infection during his stay in the ICU.
Measured: 2000 to 2017
Mechanical ventilation related complications.
Whether the patient had any mechanical ventilation related complications during his stay in the ICU.
Measured: 2000 to 2017
Bedrest complications: bedsores
Whether the patient acquired bedsores during his ICU stay.
Measured: 2000 to 2017
Bedrest complications: thrombo-embolic complications
Whether the patient acquired thrombo-embolic complications (deep vein thrombosis or pulmonary embolism) during his ICU stay.
Measured: 2000 to 2017
Disability at ICU discharge
Modified Rankin scale at ICU discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.
Measured: 2000 to 2017
Disability at hospital discharge
Modified Rankin scale at hospital discharge, from 0 to 6, with 0 being asymptomatic and 6 being death.
Measured: 2000 to 2017
Last known disability
Last known modified Rankin scale, from 0 to 6, with 0 being asymptomatic and 6 being death.
Measured: 2000 to 2017
Survival at hospital discharge
Proportion of patients alive at hospital discharge
Measured: 2000 to 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Jan 2000
- Primary completion31 Dec 2017
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Botulism; PoisoningStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Guitton, MD, Principal investigator, Centre Hospitalier le Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658902
- Sponsor's protocol ID
- CHM-2017-538/05
- Acronym
- BotuREA
- Status last verified
- Sep 2018
- First submitted
- 31 Aug 2018
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Epidemiological Study on Patients Admitted for Botulism Poisoning in Intensive Care Units in France
- ClinicalTrials.gov ID
- NCT03658902
- Acronym / sponsor ID
- BotuREA / CHM-2017-538/05
- Conditions
- Botulism; Poisoning
- Keywords
- Botulism, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 6 Sep 2018 (actual)
- 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.
Botulism poisoning is a rare but serious illness. Because of it's low incidence, it is not well known by physicians. Most studies describing botulism date back to the last century and do not take into account recent advances in intensive care.
The objective of this study is to describe the clinical course, interventions and outcomes of patients with severe botulism poisoning requiring a hospitalisation in an intensive care or high dependancy unit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients 15 years of age or older with a clinical diagnosis of botulism.
Key inclusion criteria (2 listed)
- Clinical diagnosis of botulism
- Admission in an intensive care or high dependancy unit
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 2000 to 2017
Proportion of patients alive at ICU discharge
31 secondary outcomes
Age
Time frame: 2000 to 2017
Weight
Time frame: 2000 to 2017
Height
Time frame: 2000 to 2017
History of motor impairment measured by the modified Rankin scale
Time frame: 2000 to 2017
History of heart failure measured by the NYHA (New York Health Association) score
Time frame: 2000 to 2017
History of chronic respiratory failure: use of daily oxygen therapy AND/OR non invasive ventilation
Time frame: 2000 to 2017
History of chronic kidney disease measured by the glomerular filtration rate.
Time frame: 2000 to 2017
History of cirrhosis as measured by the CHILD-PUGH score.
Time frame: 2000 to 2017
Source of the contamination
Time frame: 2000 to 2017
Isolated or multiple cases
Time frame: 2000 to 2017
Botulinum Toxin type if identified
Time frame: 2000 to 2017
Severity at ICU admission
Time frame: 2000 to 2017
Mechanical ventilation requirement
Time frame: 2000 to 2017
Invasive mechanical ventilation requirement
Time frame: 2000 to 2017
Non invasive mechanical ventilation requirement
Time frame: 2000 to 2017
Whether or not the patient required a tracheotomy during his ICU stay.
Time frame: 2000 to 2017
Enteral or parenteral nutritional support
Time frame: 2000 to 2017
Number of days of vasopressor support
Time frame: 2000 to 2017
Acute kidney injury measured by maximum serum creatinine during ICU stay.
Time frame: 2000 to 2017
Severe liver failure
Time frame: 2000 to 2017
Whether or not antitoxin was administered to the patient.
Time frame: 2000 to 2017
Whether or not guanidine was administered during ICU stay
Time frame: 2000 to 2017
Length of stay.
Time frame: 2000 to 2017
Healthcare acquired infection
Time frame: 2000 to 2017
Mechanical ventilation related complications.
Time frame: 2000 to 2017
Bedrest complications: bedsores
Time frame: 2000 to 2017
Bedrest complications: thrombo-embolic complications
Time frame: 2000 to 2017
Disability at ICU discharge
Time frame: 2000 to 2017
Disability at hospital discharge
Time frame: 2000 to 2017
Last known disability
Time frame: 2000 to 2017
Survival at hospital discharge
Time frame: 2000 to 2017
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 1 Jul 2026.
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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.
Christophe Guitton, MD principal investigator
Centre Hospitalier le Mans
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; Poisoning, run by Centre Hospitalier le Mans at 1 site in France.
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 2 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 1 Jul 2026. 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 France. 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.
What does the primary outcome measure?
Survival (time frame: 2000 to 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.