Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-02 @ 9:34 AM
Study NCT ID:
NCT00465257
Status:
SUSPENDED
Last Update Posted:
2008-05-20
First Post:
2007-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar
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': 'C515299', 'term': 'amodiaquine, artesunate drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'whyStopped': 'Due to lack of malaria patients in Zanzibar the study has been suspended.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'lastUpdateSubmitDate': '2008-05-16', 'studyFirstSubmitDate': '2007-04-23', 'studyFirstSubmitQcDate': '2007-04-23', 'lastUpdatePostDateStruct': {'date': '2008-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCR adjusted parasitological cure rate by day 42.'}]}, 'conditionsModule': {'conditions': ['Malaria']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age below 60 months\n* Weight ≥5kg\n* No general danger signs or severe malaria present (see 4.4.2.1 \\& 4.4.2.2)\n* History of fever within 24 hours OR axillary temperature ≥ 37.5Cº\n* No other cause of fever is detectable\n* No severe malnutrition\n* Presence of P. falciparum asexual parasite density between 2000- 200,000/ul\n* Guardian/Patient has understood the procedures of the study and is willing to participate\n* Patient able to come for stipulated follow up visits and has easy access to the Study Site\n\nExclusion Criteria:\n\n* Not able to drink or breastfeed\n* Persistent Vomiting\n* Recent history of convulsions\n* Lethargic or unconscious\n* Unable to sit or stand (as appropriate for age)\n* History of allergy to test drugs\n* History of intake of any drugs other than paracetamol and aspirin within 3 days'}, 'identificationModule': {'nctId': 'NCT00465257', 'briefTitle': 'Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar', 'orgStudyIdInfo': {'id': 'ACOIII'}}, 'armsInterventionsModule': {'interventions': [{'name': 'artesunate + amodiaquine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kivunge', 'state': 'North A District, Zanzibar', 'country': 'Tanzania', 'facility': 'Kivunge Cottage Hospital', 'geoPoint': {'lat': -5.88333, 'lon': 39.28333}}], 'overallOfficials': [{'name': 'Anders Björkman, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska UH'}, {'name': 'Guida Rotlland, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska UH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}}}}