An observational study in Botulism; Poisoning, sponsored by Centre Hospitalier le Mans. Completed at 1 site in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Centre Hospitalier le Mans · Observational
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.
20 studies on the registry are indexed under Botulism; 3 are open to participants now.
Browse Botulism studies →Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients 15 years of age or older with a clinical diagnosis of botulism.
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.
Exclusion Criteria:
Survival
Proportion of patients alive at ICU discharge
Time frame: 2000 to 2017
Age
Mean age of recruited patients
Time frame: 2000 to 2017
Weight
Mean weight of recruited patients
Time frame: 2000 to 2017
Height
Mean Height of recruited patients
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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%).
Time frame: 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.
Time frame: 2000 to 2017
Isolated or multiple cases
Whether the poisoning is isolated or one of multiple cases originating from the same source.
Time frame: 2000 to 2017
Botulinum Toxin type if identified
Botulinum toxin type if identified (A,B,C,D,E,F,G or H type toxin).
Time frame: 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%.
Time frame: 2000 to 2017
Mechanical ventilation requirement
Whether the patient required or not mechanical ventilation during his ICU stay
Time frame: 2000 to 2017
Invasive mechanical ventilation requirement
Whether the patient required or not invasive mechanical ventilation during his ICU stay
Time frame: 2000 to 2017
Non invasive mechanical ventilation requirement
Whether the patient required or not non invasive mechanical ventilation during his ICU stay
Time frame: 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
Time frame: 2000 to 2017
Enteral or parenteral nutritional support
Whether the patient required or not enteral or parenteral nutritional support during his ICU stay
Time frame: 2000 to 2017
Number of days of vasopressor support
Number of days the patient required vasopressor support during his ICU stay
Time frame: 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.
Time frame: 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.
Time frame: 2000 to 2017
Whether or not antitoxin was administered to the patient.
Whether botulinum antitoxin was administered.
Time frame: 2000 to 2017
Whether or not guanidine was administered during ICU stay
Whether guanidine was administered as a treatment for the botulinum poisoning.
Time frame: 2000 to 2017
Length of stay.
Number of hospitalisation days in the ICU.
Time frame: 2000 to 2017
Healthcare acquired infection
Whether the patient acquired a healthcare related infection during his stay in the ICU.
Time frame: 2000 to 2017
Mechanical ventilation related complications.
Whether the patient had any mechanical ventilation related complications during his stay in the ICU.
Time frame: 2000 to 2017
Bedrest complications: bedsores
Whether the patient acquired bedsores during his ICU stay.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2000 to 2017
Last known disability
Last known modified Rankin scale, from 0 to 6, with 0 being asymptomatic and 6 being death.
Time frame: 2000 to 2017
Survival at hospital discharge
Proportion of patients alive at hospital discharge
Time frame: 2000 to 2017
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier le Mans