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CompletedNCT03310697CASToxUpdated Oct 28, 2021

Toxicological Screening by GC-MS Among Children Admitted for a First Afebrile Seizure

An interventional study of Collection of blood and urine samples and Clinical examination in Afebrile Seizure (Finding), sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 1 Month to 15 Years. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Screening

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Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
1 Month to 15 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 14 studies in Signs and Symptoms with a site in France — 4 open to participants now, 5 under way, 1 of them phase 3. Signs and Symptoms · France.

Started
2017
with 1 other
No phase
5 of 14
2 open now
Registered
4th of 14
by date

Among the 14 studies in Signs and Symptoms with a site in France, this one is one of 2 that started in 2017, is one of 5 with no phase, and was the 4th registered.

Signs and Symptoms

221 studies on the registry are indexed under Signs and Symptoms; 22 are open to participants now.

Browse Signs and Symptoms studies →

Open to participants now

4 of the 14 studies in Signs and Symptoms with a site in France are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 15 Signs and Symptoms studies recruiting now, 9 (60%) set no upper age limit and 3 (20%) stop at 75 or younger; 1 takes children under 18; 3 take healthy volunteers.

This study: 1 Month to 15 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

Before the age of 14 years, 1% of the paediatric population will develop a seizure. The only systematically required complementary examination is an electroencephalogram (EEG). Additional biological or radiological examinations depend on the circumstances, the past medical history of the patient and other associated symptoms or clinical signs. A seizure can be the first sign of acute intoxication and represents a severity criterion. Failure to detect the toxic cause of a seizure can lead to a delay in the access or administration of an antidote if applicable. This can lead to target organ toxicity due to the absence of specific treatment. In the current French guidelines for a first seizure, a toxicological analysis is recommended if there is a possibility of exposure to toxic medications or products. However, this screening is often missing, unless a witness suggests that the child may have been exposed to a toxin.The recognition of a paediatric toxidrome is low among paediatricians, paediatric neurologists or emergency physicians. This is due to a lack of knowledge in clinical toxicology and the screening for toxic aetiology is not frequently or irrelevantly prescribed. There is an increasing number of proconvulsive molecules on the market. These molecules are not targeted in classic toxic screening. As result, a toxic cause of a seizure may be missed unless specific screening is performed. For all these reasons, little is known about the prevalence of toxic causes after a first episode of non-febrile seizure and probably under estimated in the paediatric population, especially in young children. New technologies for toxic detection like chromatography combined with mass spectrometry allow wide screening on different matrix. Initially dedicated to forensic analysis, they are more widely accessible for the exploration of the patients. The CASTox study is based on this context.

The first aim will be to evaluate the prevalence of a toxicological cause by a systematic blood and urine screening of children admitted to Toulouse paediatric emergency unit for a first afebrile seizure. Moreover, secondary aim will be to describe the effect of the systematic screening on the management of the children.

Read the detailed description

Before the age of 14 years, 1% of the paediatric population will develop a seizure. The only systematically required complementary examination is an electroencephalogram (EEG). Additional biological or radiological examinations depend on the circumstances, the past medical history of the patient and other associated symptoms or clinical signs. A seizure can be the first sign of acute intoxication and represents a severity criterion. Failure to detect the toxic cause of a seizure can lead to a delay in the access or administration of an antidote if applicable. This can lead to target organ toxicity due to the absence of specific treatment. In the current French guidelines for a first seizure, a toxicological analysis is recommended if there is a possibility of exposure to toxic medications or products. However, this screening is often missing, unless a witness suggests that the child may have been exposed to a toxin.The recognition of a paediatric toxidrome is low among paediatricians, paediatric neurologists or emergency physicians. Since the end of the 90s, the molecules usually incriminated with seizure onset after intoxication are: with a high risk (polycyclic antidepressant, theophylline, isoniazid); intermediate risk (fluoroquinolones, tramadol, lidocaine, lithium, anticonvulsive medications) and low risk (selective serotonin reuptake inhibitors). Among infants, the molecules are quite different mainly because of the unintentional or malicious aspect of the intoxication and are dominated by sympathomimetic agents, antihistamine drugs, anticholinergic molecules, antidepressants and muscle relaxants. New drugs have been associated with seizures in young intoxicated children like bupropion, tramadol and venlafaxine. These agents are not detected by usual toxic analysis.

For each patient and after getting the signed consent form, a toxicological analysis will be performed on blood and urine samples to extensively screen for proconvulsive molecules (alcohols, polycyclic antidepressants, salicylates, anticonvulsive medications (carbamazepine, phenytoin, valproic acid), drugs (cocaine and its metabolites, amphetamines, methamphetamine (ecstasy), cannabis, buprenorphine, methadone, mephedrone, codeine, pholcodine, hydromorphone), benzodiazepines, caffeine, theophylline, lidocaine, isoniazid, mefenamic acid, tramadol, ephedrine).

This analysis will be performed using classic approach (immunoenzymatic detection) and by chromatography (GC) associated to mass spectrometry (MS) (Laboratory of Toxicology, University Hospital of Toulouse) - The other clinical data, biological results or tests requested by the physician in charge will be reported from the computerized medical file of each patient.

For each patient hospitalized, a follow-up visit will be scheduled during hospitalization in order to report management of the children.

03

Conditions studied

  • Afebrile Seizure (Finding)

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Keywords

  • Afebrile seizure
  • Toxicological screening
  • Chromatography
  • Mass spectrometry
  • Children
04

Who can participate

Ages eligible
1 Month to 15 Years
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

  • Being aged between 1 month and 15 years for boys and 1 month and 11 years for girls
  • Any first episode of afebrile seizure, independent of duration, type (generalized or not) occurring in children without any previous neurological history and admitted to Toulouse level III paediatric emergency unit (University Children Hospital, Toulouse)
  • Consent form signed by parents or legal guardian

Exclusion criteria

Exclusion Criteria:

  • Patient transferred from another hospital
  • Absence of consent form signed by parents or legal guardian
  • Seizure in a febrile context at the moment of inclusion
  • Known history of neurological disorders
  • Any kind of diagnosed epilepsy
  • Renal or hepatocellular insufficiency
  • Recent head trauma
  • Coagulation disorders (hemophilia, secondary or primary thrombopenia)
  • Known exposure to toxic molecules
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Children with afebrile seizure

    For each child, a toxicological screening will be carried out on the blood and urine for the research of proconvulsive molecules by conventional technique on the one hand and by gas chromatography coupled with a mass spectrograph on the other hand. Intervention : Collection of blood and urine samples, and Clinical examination

    Other: Collection of blood and urine samples · Other: Clinical examination

Interventions

  • OtherCollection of blood and urine samples

    For each child, a toxicological screening will be carried out on the blood and urine for the research of proconvulsive molecules by conventional technique on the one hand and by gas chromatography coupled with a mass spectrograph on the other hand.

  • OtherClinical examination

    The other clinical data, any other biological samples or additional examinations are done under the opinion of the clinician or the neuropediatrics.

06

What researchers measure

Primary outcomes

  1. Detection of one or several toxic molecules.

    Analyzed by systematic screening of a blood and urine sample.

    Time frame: Day 1

Secondary outcomes

  1. The delay of detection of a cause for a first afebrile seizure in paediatric patients.

    It is the time between the admission to paediatric emergency unit and the detection of the first afebrile seizure's cause for paediatric patients

    Time frame: Day 1

  2. The length of stay in Toulouse paediatric emergency unit or in hospitalization.

    Time frame: Day 1

  3. number of tests performed in the search of an aetiology

    Time frame: Day 1

  4. The number of tests performed in the search of an aetiology.

    Time frame: Day 1

07

Study locations

1 site
  • Hôpital des enfants
    Toulouse, Midi-Pyrénées 31059, France
08

References and documents

Publications

  • Bartoli M, Berny C, Danel V, Delahaye A, Desch G, Guitton J, Lacarelle B, Lapostolle F, Mathieu D, Megarbane B, Nisse P, Szymanowicz A, Capolaghi B; Toxicology and Clinical Biology Working Group. [Recommendations for the prescription, implementation and interpretation of medical examinations in biology in the context of severe poisoning]. Ann Biol Clin (Paris). 2012 Jul-Aug;70(4):431-50. doi: 10.1684/abc.2012.0726. French. PubMed 22796615 ↗
  • Hauser WA, Beghi E. First seizure definitions and worldwide incidence and mortality. Epilepsia. 2008;49 Suppl 1:8-12. doi: 10.1111/j.1528-1167.2008.01443.x. PubMed 18184148 ↗
  • Chelse AB, Kelley K, Hageman JR, Koh S. Initial evaluation and management of a first seizure in children. Pediatr Ann. 2013 Dec;42(12):244-8. doi: 10.3928/00904481-20131122-08. PubMed 24295157 ↗
  • Finkelstein Y, Hutson JR, Freedman SB, Wax P, Brent J; Toxicology Investigators Consortium (ToxIC) Case Registry. Drug-induced seizures in children and adolescents presenting for emergency care: current and emerging trends. Clin Toxicol (Phila). 2013 Sep-Oct;51(8):761-6. doi: 10.3109/15563650.2013.829233. Epub 2013 Aug 19. PubMed 23957582 ↗
  • Thundiyil JG, Kearney TE, Olson KR. Evolving epidemiology of drug-induced seizures reported to a Poison Control Center System. J Med Toxicol. 2007 Mar;3(1):15-9. doi: 10.1007/BF03161033. PubMed 18072153 ↗
  • Reichert C, Reichert P, Monnet-Tschudi F, Kupferschmidt H, Ceschi A, Rauber-Luthy C. Seizures after single-agent overdose with pharmaceutical drugs: analysis of cases reported to a poison center. Clin Toxicol (Phila). 2014 Jul;52(6):629-34. doi: 10.3109/15563650.2014.918627. Epub 2014 May 20. PubMed 24844578 ↗
  • Thundiyil JG, Rowley F, Papa L, Olson KR, Kearney TE. Risk factors for complications of drug-induced seizures. J Med Toxicol. 2011 Mar;7(1):16-23. doi: 10.1007/s13181-010-0096-4. PubMed 20661684 ↗
  • Citak A, Soysal DD, Ucsel R, Karabocuoglu M, Uzel N. Seizures associated with poisoning in children: tricyclic antidepressant intoxication. Pediatr Int. 2006 Dec;48(6):582-5. doi: 10.1111/j.1442-200X.2006.02276.x. PubMed 17168978 ↗
  • Sharma AN, Hoffman RJ. Toxin-related seizures. Emerg Med Clin North Am. 2011 Feb;29(1):125-39. doi: 10.1016/j.emc.2010.08.011. PubMed 21109109 ↗
  • Chen HY, Albertson TE, Olson KR. Treatment of drug-induced seizures. Br J Clin Pharmacol. 2016 Mar;81(3):412-9. doi: 10.1111/bcp.12720. Epub 2015 Sep 17. PubMed 26174744 ↗
  • Cerminara C, El-Malhany N, Roberto D, Lo Castro A, Curatolo P. Seizures induced by desloratadine, a second-generation antihistamine: clinical observations. Neuropediatrics. 2013 Aug;44(4):222-4. doi: 10.1055/s-0033-1333871. Epub 2013 Mar 1. PubMed 23456992 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Oct 2020, 33 months.

Of 58 non-industry interventional studies with no phase under Signs and Symptoms, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 33 months is above that.

Counting every sponsor, half of 69 studies reached it within 17 months; a quarter within 6 and three quarters within 37.

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

Registered
Jul 20, 2017
First posted
Oct 16, 2017
StartActual
Dec 19, 2017
Primary completionActual
Oct 6, 2020
CompletionActual
Oct 6, 2020
Last update
Oct 28, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
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.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03310697
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Dec 19, 2017
Primary completion
Oct 6, 2020
Completion
Oct 6, 2020
Last update
Oct 28, 2021

Study contacts

Isabelle Claudet, MD
principal investigator · CHU Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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