Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-04 @ 3:58 PM
Study NCT ID:
NCT02563704
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2015-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2015-09-19', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fever clearance time', 'timeFrame': 'Time (in hours) from the onset of treatment till rectal temperature went down to 37.5°C for at least 24 hour'}, {'measure': 'Coma recovery time', 'timeFrame': 'Time (in hours) from the onset of treatment till the participant was fully conscious with a BCS of 5 or GCS of 15 for an average of 24 hours'}, {'measure': 'Time to sit unsupported', 'timeFrame': 'Time (in hours) from the onset of treatment till when the participant could sit unsupported for an average of 24 hours if the participant was unable to do so on admission'}, {'measure': 'Time to eat and drink', 'timeFrame': 'Time (in hours) from the onset of treatment till when the participant could eat and drink for an average of 24 hours if the participant was unable to do so on admission'}, {'measure': 'Parasite clearance time', 'timeFrame': 'Time (in hours) from the onset of treatment to the time of the first of two successive negative blood smear through hospital discharge, an average of one week'}, {'measure': 'Parasite reduction rate 24 hours after onset of treatment', 'timeFrame': '24 hours from onset of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Artesunate', 'Quinine', 'Efficacy', 'Malaria', 'Children', 'Cameroon'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '27923381', 'type': 'DERIVED', 'citation': 'Maka DE, Chiabi A, Obadeyi B, Mah E, Nguefack S, Nana P, Mbacham W, Mbonda E. Economic evaluation of artesunate and three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital-Cameroon: a cost analysis. Malar J. 2016 Dec 7;15(1):587. doi: 10.1186/s12936-016-1639-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate with three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital located in the South region of Cameroon'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children presenting with one or more signs of severity of malaria according to the 2013 Cameroon National Malaria Control Programme adopted criteria (impaired consciousness, abnormal behaviour, convulsions, prostration, persistent vomiting, jaundice, hyperthermia, acute respiratory distress, clinical acidosis, haemoglobinuria, cardiovascular shock, dehydration, abnormal bleeding, severe anaemia, renal impairment, hypoglycaemia and hyperparasitaemia)\n* and having an initial positive parasitaemia to Plasmodium falciparum\n* Other aetiologies of the presenting symptoms excluded\n* Written consent from parent(s)\n\nExclusion Criteria:\n\n* Prior side effects to either artesunate or quinine administration\n* Severely malnourished children\n* Concomitant infection'}, 'identificationModule': {'nctId': 'NCT02563704', 'briefTitle': 'A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon', 'organization': {'class': 'OTHER', 'fullName': 'University of Yaounde 1'}, 'officialTitle': 'A Randomized Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon', 'orgStudyIdInfo': {'id': 'UYaounde1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ARTES', 'description': '* Injectable Artesunate.Each vial contained 60 mg anhydrous artesunic acid, which was dissolved in 1 ml of 5% sodium bicarbonate (provided with the drug) and then mixed with 5 ml saline solution (provided with the drug) before injecting into an indwelling intravenous catheter.\n* Patients received 2.4 mg/kg bw of parenteral artesunate at H0, H12, H24 and thereafter once daily, for a minimum of 24 hours.\n* Patients exited from the protocol if they had clinically recovered and parasitaemia was negative.', 'interventionNames': ['Drug: Artesunate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'QLD', 'description': '* Injectable quinine. Each vial contained 250 mg or 500 mg QB.\n* Patients received a loading dose of 16.6 mg/kg bw of QB by intravenous (IV) infusion over 4 hours followed 8 hours after the start of the loading dose, with a maintenance dose of QB at 8.3 mg/kg bw over 4 hours every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution.\n* Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.', 'interventionNames': ['Drug: Quinine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'QNLD3', 'description': '* Injectable quinine. Each vial contained 250 mg or 500 mg QB.\n* Patients received 8.3 mg/kg bw of QB over 4 hours by IV infusion every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution.\n* Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.', 'interventionNames': ['Drug: Quinine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'QNLD2', 'description': '* Injectable quinine. Each vial contained 250 mg or 500 mg QB.\n* Patients received 12.5 mg/kg bw of QB over 4 hours by IV infusion every 12 hours diluted in 10 ml/kg bw of 10% dextrose solution.\n* Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.', 'interventionNames': ['Drug: Quinine']}], 'interventions': [{'name': 'Artesunate', 'type': 'DRUG', 'armGroupLabels': ['ARTES']}, {'name': 'Quinine', 'type': 'DRUG', 'armGroupLabels': ['QLD', 'QNLD2', 'QNLD3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elie MBONDA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine and Biomedical Sciences, University of Yaounde I'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Yaounde 1', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'ETHE MAKA Daniel', 'investigatorAffiliation': 'University of Yaounde 1'}}}}