Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT02899702
Status:
WITHDRAWN
Last Update Posted:
2021-05-03
First Post:
2016-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no EC approval obtained', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2016-09-02', 'studyFirstSubmitQcDate': '2016-09-08', 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'organ dysfunctions', 'timeFrame': 'between day of admission and day 3', 'description': 'Average variation in Pediatric Logistic Organ Dysfunction 2 ( PELOD-2) score compared between the IVIG treatment arm and the placebo arm.'}], 'secondaryOutcomes': [{'measure': 'global mortality', 'timeFrame': '1 year'}, {'measure': 'disability assessed by the Pediatric Overall Performance Category (POPC) score', 'timeFrame': 'one year after recruitment'}, {'measure': 'impairment assessed by the Vineland Adaptive Behavior Scale 2 (VABS II)', 'timeFrame': 'one year after recruitment'}, {'measure': 'organ dysfunctions assessed by the PELOD-2 score', 'timeFrame': 'over the first 5 days in Paediatric Intensive Care Unit (PICU)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Staphylococcal Infection', 'Streptococcal Infection']}, 'descriptionModule': {'briefSummary': 'IGHN2 is an international, multicenter, double blind, randomized controlled trial aimed at assessing the efficacy on organ dysfunctions of Intravenous Immunoglobulins (IVIG) treatment in the acute phase of streptococcal or staphylococcal toxic shock syndrome in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child/adolescent: 1 month \\< Age \\< 17 year-old,\n* admitted to PICU with a strong suspicion of staphylococcal or streptococcal infection; at least one following criterion, with at least one following criteria:\n\n 1. Toxic Shock Syndrom as defined by Centre for Disease Control criteria\n 2. or group A Streptococcus necrotizing fasciitis (positive streptest)\n 3. or varicella with infected lesions and rash or positive streptest\n 4. or erythrodermic rash in menstrual period\n 5. or pleuropneumonia with erythrodermic rash or positive streptest in pleural fluid\n 6. or erythrodermic rash and biological fluid positive to streptococcus A or staphylococcus (articular, pericardial, bronchopulmonary, pharynx)\n* With shock resistant to fluid resuscitation, defined as existence, despite 40 ml/kg of fluid bolus within 1 hour, of:\n\n 1. hypotension (\\< 5th percentile)\n 2. or systolic blood pressure \\< 2 SD regarding age\n 3. or need for vasoactive drugs in order to maintain blood pressure at a normal level (dopamine \\> 5µg/kg/min or dobutamine, adrenaline, noradrenaline, milrinone whatever the dose)\n 4. or 2 signs of hypo perfusion among:\n\n 1. metabolic acidosis with base deficit \\> 5\n 2. lactate x 2 normal laboratory value\n 3. diuresis \\< 0,5 ml/kg/h\n 4. capillary refill time \\> 5 sec\n 5. Skin/central temperature difference \\> 3°C\n* With informed consent signed by at least one parent before any procedures or treatments related to the study.\n\nExclusion Criteria:\n\n* First signs of shock appeared more than 24h ago\n* Known hypersensitivity to one of the components (study treatment or placebo , see below)\n* Hypersensitivity to homologous immunoglobulins, specifically in very rare cases of Ig A deficit, when the patient has anti-IgA antibodies\n* Known hyperprolinemia\n* Immunodeficiency (acquired or not),\n* Immunosuppressive drugs\n* No health cover'}, 'identificationModule': {'nctId': 'NCT02899702', 'acronym': 'IGHN2', 'briefTitle': 'Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children: a Multicentre European Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '69HCL16_0079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVIG', 'description': 'PRIVIGEN (CSL Behring) NORMAL HUMAN IMMUNOGLOBULINS L-PROLINE, Water for injection', 'interventionNames': ['Drug: PRIVIGEN (CSL Behring)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'Single administration of Albumin 4% diluted albumin (LFB), within 12 hours following PICU admission (or outbreak of first shock signs). Isovolume - so dose of 0.8 g/kg We chose as placebo albumin diluted to 4% because this solution has the advantage of having a comparable osmolality.\n\nThe treatment of toxic shock will be standardized. It consists of antibiotics: Amoxicillin-clavulanate and clindamycin (or Rifampicin, Rifadine® if allergic). Antibiotics are not considered as experimental treatments for this study. All treatments essential for the treatment of acute condition will be allowed and are not considered as experimental treatments for this study.', 'interventionNames': ['Drug: Albumin']}], 'interventions': [{'name': 'PRIVIGEN (CSL Behring)', 'type': 'DRUG', 'description': 'Single administration of intravenous immunoglobulin solution Privigen® (CSL Behring AG, Bern, Switzerland) at a dose of 2g / kg. IGIV 2g/kg within 12 hours following PICU admission (or outbreak of first shock signs).\n\nThe treatment of toxic shock will be standardized. It consists of antibiotics: Amoxicillin-clavulanate and clindamycin (or Rifampicin, Rifadine® if allergic). Antibiotics are not considered as experimental treatments for this study. All treatments essential for the treatment of acute condition will be allowed and are not considered as experimental treatments for this study.', 'armGroupLabels': ['IVIG']}, {'name': 'Albumin', 'type': 'DRUG', 'description': '4%(LFB) ALBUMIN Single administration of human Albumin 4% diluted albumin (VIALEBEX® LFB), within 12 hours following PICU admission (or outbreak of first shock signs). Isovolume - so dose of 0.8 g/kg (4gG, 100 ML, Sodium chloride 0.61 G / 100ML Water for injections QSP 100 ML Sodium caprylate 0.3 G / 100ML) We chose as placebo albumin diluted to 4% because this solution has the advantage of having a comparable osmolality.\n\nThe treatment of toxic shock will be standardized. It consists of antibiotics: Amoxicillin-clavulanate and clindamycin (or Rifampicin, Rifadine® if allergic). Antibiotics are not considered as experimental treatments for this study. All treatments essential for the treatment of acute condition will be allowed and are not considered as experimental treatments for this study.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Etienne JAVOUHEY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}