Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT01336660
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2011-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2011-04-15', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate the effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation', 'timeFrame': '4 hours after study drug', 'description': 'Comparison between antivenom and placebo groups of the number of cases showing improvement in class of envenomation.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation.', 'timeFrame': 'To 16 hours after treatment until discharge time and date', 'description': 'Decrease in plasma venom levels from baseline to one hour after study drug administration; Respiratory rate (breaths per minute); Heart rate (beats per minute); Dose of dobutamine (cumulative, per hour);Incidence of cardiac failure; Incidence of ventilatory failure; Incidence of neurological failure; Mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Effectiveness', 'New Antivenom', 'North Africa and Middle East Scorpio Envenomation'], 'conditions': ['Poisoning by Scorpion Sting']}, 'descriptionModule': {'briefSummary': 'This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the treatment of North Africa and Middle East scorpions envenomation by reducing the severity of envenomation. The primary endpoint is make a comparison between antivenom and placebo groups, at 4 hours after study drug, of the number of cases showing improvement in class of envenomation.', 'detailedDescription': 'In an effort to shorten hospital stay and to further decrease mortality, a new antivenom has been developed. This antivenom is a third generation F(ab\')2 "fabotherapeutic" agent.It is administered intravenously which should lead to rapid neutralization of circulating venom. This study will demonstrate whether or not use of the new antivenom in children receiving standardized supportive care leads to resolution of the syndrome within 4 hours of treatment.The onset of clinical symptoms following a scorpion envenomation is usually within 5 to 30 minutes following the sting.\n\nEstablished a classification of the patient status to differentiate a simple scorpion sting from a severe envenomation. A simple sting (class I) is characterized by signs that are local only: pain at the inoculation point, redness, edema, and numbness.\n\nA class II envenomation is characterized by the presence of some systemic signs: hypothermia, hyperthermia, chills, nausea, abdominal pain and diarrhea. Being 15 years old or younger or the presence of priapism, vomiting, sweating, or a body temperature greater than 39°C are factors predictive of severity.\n\nA severe envenomation (class III) is characterized by cardiovascular failure, often leading to death; respiratory failure related to the cardiac failure; and neurologic failure due to hypoxia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 6 months to 15 years\n* Class II B or III scorpion envenomation\n* Presenting within 5 hours of sting\n* Informed consent read and signed by parent or legal guardian\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Prior use of antivenom for this envenomation\n* Allergy to horse serum\n* Pregnant or breast-feeding\n* Patients with underlying condition mimicking symptoms of scorpion envenomation (congenital heart disease, chronic oxygen therapy, etcetera)'}, 'identificationModule': {'nctId': 'NCT01336660', 'briefTitle': "A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco", 'organization': {'class': 'INDUSTRY', 'fullName': 'Instituto Bioclon S.A. de C.V.'}, 'officialTitle': "Phase 2/3 Study for Scorpion North Africa Middle East Envenomation With a Immune F(ab')2 (Equine) Antivenom Alacramyn NAMO. A Randomized, Double-Blind, Placebo-controlled, Prospective and Multicenter Study", 'orgStudyIdInfo': {'id': 'XM-10/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Equine F(ab')2 antivenom", 'description': "Intensive care support and Equine F(ab')2 antivenom", 'interventionNames': ["Biological: Equine F(ab')2 antivenom"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intensive care support plus placebo', 'interventionNames': ['Other: Intensive care support plus placebo']}], 'interventions': [{'name': "Equine F(ab')2 antivenom", 'type': 'BIOLOGICAL', 'otherNames': ['Alacramyn NA', "Scorpion North Africa and Middle East Immune F(ab')2(Equine)"], 'description': "A single dose of 4 vials of Equine F(ab')2 antivenom will be administered intravenously over 10 minute", 'armGroupLabels': ["Equine F(ab')2 antivenom"]}, {'name': 'Intensive care support plus placebo', 'type': 'OTHER', 'description': 'Intensive care support as needed plus placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fes', 'country': 'Morocco', 'facility': 'CHU Hassan II de Fès', 'geoPoint': {'lat': 34.03313, 'lon': -5.00028}}, {'city': 'Marrakesh', 'country': 'Morocco', 'facility': 'Hôpital Ibn Zohr, Marrakech', 'geoPoint': {'lat': 31.63416, 'lon': -7.99994}}], 'overallOfficials': [{'name': 'Walter Garcia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto Bioclon'}, {'name': 'Rachida Soulaymani, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre Antipoison et de Pharamacovigilance du Maroc'}, {'name': 'Sanae Achour', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FES University Hospital'}, {'name': 'Asmae Khattabi', 'role': 'STUDY_CHAIR', 'affiliation': 'Ecole Nationale de Santé Publique'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'not yet decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Bioclon S.A. de C.V.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centre Antipoison et de Pharmacovigilane du Maroc', 'class': 'UNKNOWN'}, {'name': 'Institut Pasteur du Maroc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}