Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-01 @ 12:10 PM
Study NCT ID:
NCT02411994
Status:
COMPLETED
Last Update Posted:
2017-11-27
First Post:
2015-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria
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': 'C000712628', 'term': 'pyronaridine tetraphosphate, artesunate drug combination'}, {'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}], 'ancestors': [{'id': 'D000077549', 'term': 'Artemether'}, {'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': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-24', 'studyFirstSubmitDate': '2015-04-03', 'studyFirstSubmitQcDate': '2015-04-07', 'lastUpdatePostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCR-corrected adequate clinical and parasitological response (ACPR)', 'timeFrame': 'day 28 after initial dose'}], 'secondaryOutcomes': [{'measure': 'PCR-corrected adequate clinical and parasitological response (ACPR)', 'timeFrame': 'day 42 after initial dose'}, {'measure': 'crude adequate clinical and parasitological response (ACPR)', 'timeFrame': 'day 28, day 42 after initial dose'}, {'measure': 'parasite clearance time', 'timeFrame': 'up to 7 days after initial dose'}, {'measure': 'gametocyte clearance time', 'timeFrame': 'up to 7 days after initial dose'}, {'measure': 'transmission potential to mosquitos', 'timeFrame': 'day 7 after initial dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '29866116', 'type': 'DERIVED', 'citation': 'Roth JM, Sawa P, Omweri G, Osoti V, Makio N, Bradley J, Bousema T, Schallig HDFH, Mens PF. Plasmodium falciparum gametocyte dynamics after pyronaridine-artesunate or artemether-lumefantrine treatment. Malar J. 2018 Jun 4;17(1):223. doi: 10.1186/s12936-018-2373-7.'}, {'pmid': '29764419', 'type': 'DERIVED', 'citation': 'Roth JM, Sawa P, Makio N, Omweri G, Osoti V, Okach S, Choy F, Schallig HDFH, Mens P. Pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial. Malar J. 2018 May 15;17(1):199. doi: 10.1186/s12936-018-2340-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children between 6 months and 12 years old, with a body weight of ≥5 kg;\n* Living in the catchment area of the study (within a radius of \\~10 km from St. Jude's Clinic, Mbita, Kenya);\n* Having microscopically confirmed P. falciparum mono-infection (asexual parasite density 1,000-200,000 µL-1).\n\nExclusion Criteria:\n\n* Signs and symptoms of severe malaria (according to WHO criteria for severe malaria, (WHO 2012)) or any other severe illness necessitating parenteral treatment;\n* Mixed Plasmodium infection;\n* Clinically suspected (oedema, jaundice and/or ascites) or reported hepatic and/or renal impairment (any cause, as reported by parents/guardians and/or evident from medical history);\n* Having anaemia with an Hb \\<6 g/dL;\n* Evidence of severe malnutrition (severe wasting: z-score weight for age \\<-3 and severe stunting: z-score height for age \\<-3 (WHO 2009b));\n* Having received anti-malarial therapy in the previous two weeks;\n* Known history of hypersensitivity, allergic or adverse reactions to artesunate, artemether-lumefantrine or other artemisinins;\n* Participating in other anti-malarial drug intervention studies;\n* Previous participation in the PAAL study, e.g. in the previous transmission season (each individual child can only take part in this study once);\n* Not being available for follow-up."}, 'identificationModule': {'nctId': 'NCT02411994', 'acronym': 'PAAL', 'briefTitle': 'Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria', 'organization': {'class': 'OTHER', 'fullName': 'Royal Tropical Institute'}, 'officialTitle': 'Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya', 'orgStudyIdInfo': {'id': 'KIT601714'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pyronaridine-artesunate', 'description': 'pyronaridine-artesunate: recommended dose according to body weight, once a day for three days.', 'interventionNames': ['Drug: Pyronaridine-artesunate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Artemether-lumefantrine', 'description': 'artemether-lumefantrine: recommended dose according to body weight, twice a day for three days.', 'interventionNames': ['Drug: Artemether-lumefantrine combination']}], 'interventions': [{'name': 'Pyronaridine-artesunate', 'type': 'DRUG', 'otherNames': ['Pyramax'], 'armGroupLabels': ['Pyronaridine-artesunate']}, {'name': 'Artemether-lumefantrine combination', 'type': 'DRUG', 'otherNames': ['Coartem'], 'armGroupLabels': ['Artemether-lumefantrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30-40305', 'city': 'Mbita', 'country': 'Kenya', 'facility': "St. Jude's Clinic, ICIPE", 'geoPoint': {'lat': -0.42492, 'lon': 34.20736}}], 'overallOfficials': [{'name': 'Patrick Sawa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Centre of Insect Physiology and Ecology (ICIPE)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Tropical Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}