Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT02092766
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2014-03-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2014-03-13', 'studyFirstSubmitQcDate': '2014-03-18', 'lastUpdatePostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late onset anaemia', 'timeFrame': 'Patients are hospitalized for 4 days or longer if still unwell. After discharge the follow-up consists of 6 weekly visits (time frame 42 days). Late anaemia is measured between 7 and 42 days following the start of antimalarial treatment', 'description': 'Late onset anaemia in this study is defined as a ≥10% drop in haemoglobin on any previous measurement anytime between day 7 and 42'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['malaria', 'anaemia', 'artesunate'], 'conditions': ['Anaemia']}, 'referencesModule': {'references': [{'pmid': '28818049', 'type': 'DERIVED', 'citation': 'Fanello C, Onyamboko M, Lee SJ, Woodrow C, Setaphan S, Chotivanich K, Buffet P, Jaureguiberry S, Rockett K, Stepniewska K, Day NPJ, White NJ, Dondorp AM. Post-treatment haemolysis in African children with hyperparasitaemic falciparum malaria; a randomized comparison of artesunate and quinine. BMC Infect Dis. 2017 Aug 17;17(1):575. doi: 10.1186/s12879-017-2678-0.'}]}, 'descriptionModule': {'briefSummary': 'Delayed anaemia has been reported in European travellers with malaria cured by artesunate. Although no deaths related to this delayed anaemia have been reported so far, blood transfusion has been necessary in some affected patients. Recent observations suggest that this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess the incidence of late onset anaemia after treatment with intravenous artesunate compared to intravenous quinine, to identify patients at risk and to clarify the causes of this delayed anaemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 6 months and ≤ 14 years\n* Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or mixed with non-falciparum species\n* Asexual P. falciparum parasitaemia ≥ 100,000/uL and ≤500,000/uL\n* Haemoglobin ≥5.0 g/dL\n* Parents/guardians agree to hospitalize the child for the length of treatment (3 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42\n* Signed consent from the guardian/parents\n\nExclusion Criteria:\n\n* Body weight ≤ 5 kg\n* Severe malaria or signs of severe malaria as defined by WHO Guidelines 2013\n* History of hypersensitivity or contraindication to quinine or artesunate\n* A clear history of adequate antimalarial treatment in the preceding 24 hours with drugs expected to be effective\n* Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the patient treatment or results of the study\n* Participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT02092766', 'acronym': 'DHART', 'briefTitle': 'Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria', 'orgStudyIdInfo': {'id': 'KIMORU005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV artesunate', 'description': 'Intravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total)', 'interventionNames': ['Drug: artesunate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV quinine', 'description': 'Intravenous quinine dihydrochloride 20 mg salt/kg body weight loading dose over 4 hours, then 10 mg/kg over 2 hours 8 hourly until 72 hours (9 doses total)', 'interventionNames': ['Drug: quinine']}], 'interventions': [{'name': 'artesunate', 'type': 'DRUG', 'armGroupLabels': ['IV artesunate']}, {'name': 'quinine', 'type': 'DRUG', 'armGroupLabels': ['IV quinine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kinshasa', 'country': 'Democratic Republic of the Congo', 'facility': 'Kinshasa School of Public Health', 'geoPoint': {'lat': -4.32758, 'lon': 15.31357}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kinshasa School of Public Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}