Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-05 @ 5:31 PM
Study NCT ID:
NCT06472258
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077332', 'term': 'Artesunate'}, {'id': 'D011803', 'term': 'Quinine'}], 'ancestors': [{'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002930', 'term': 'Cinchona Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy measurement between IV Artesunate and IV Artesunate plus IV Quinine Hydrochloride', 'timeFrame': 'Seven days', 'description': 'The outcome was measured in the number of hours elapsed for an individual to become fever-free.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malaria']}, 'descriptionModule': {'briefSummary': 'The WHO recommends artesunate as the drug of choice for the treatment of severe malaria. However, the efficacy of this single drug as compared to the combined drug regimen remained questionable, and the clinical response was considered delayed or inappropriate. Therefore, this research intended to evaluate the efficacy of only IV artesunate versus IV artesunate plus IV quinine in the treatment of severe malaria in children. The findings of the study would be helpful knowing whether the two drugs, when given together, have considerable benefit over single-drug therapy when given for the same.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren admitted to the emergency department with the diagnosis of severe malaria.\n\nExclusion Criteria:\n\nChildren with chronic kidney disease, chronic liver disease, immunosuppressive disorders, hematological disorders, malignancies, and congenital heart disease.'}, 'identificationModule': {'nctId': 'NCT06472258', 'briefTitle': 'Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study', 'orgStudyIdInfo': {'id': 'DGKhan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Artesunate Group', 'description': 'IV Artesunate with weight appropriate dosage on 0, 12, 24 and 48 hours, and continued 12 hourly for a maximum duration of seven days. Each dose diluted in normal saline given as infusion.', 'interventionNames': ['Drug: IV Artesunate']}, {'type': 'EXPERIMENTAL', 'label': 'Combination Group', 'description': 'IV Artesunate with weight appropriate dose on 0, 12, 24 and 48 hours, plus IV Quinine hydrochloride in accordance to weight with loading dose 20mg salt/kg in 10% dextrose infusion followed by 10mg salt/kg infusion 8 hourly for 2 days and for 12 hourly onwards for a maximum of 7 days.', 'interventionNames': ['Drug: IV Artesunate', 'Drug: IV Quinine Hydrochloride']}], 'interventions': [{'name': 'IV Artesunate', 'type': 'DRUG', 'otherNames': ['Artesunate'], 'description': 'IV artesunate with a weight-appropriate dosage at 0, 12, 24, and 48 hours and continued 12-hourly for a maximum duration of seven days, with each dose diluted in normal saline and given as an infusion.', 'armGroupLabels': ['Combination Group', 'IV Artesunate Group']}, {'name': 'IV Quinine Hydrochloride', 'type': 'DRUG', 'otherNames': ['Artesunate plus IV Quinine Hydrochloride'], 'description': 'IV Quinine hydrochloride in accordance to weight with loading dose 20mg salt/kg in 10% dextrose infusion followed by 10mg salt/kg infusion 8 hourly for 2 days and for 12 hourly onwards for a maximum of 7 days.', 'armGroupLabels': ['Combination Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32200', 'city': 'Dera Ghazi Khan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Allama Iqbal Teaching Hospital', 'geoPoint': {'lat': 30.04587, 'lon': 70.64029}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It can be shared on a reasonable request made to primary investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RESnTEC, Institute of Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}