Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-03-01 @ 4:12 PM
Study NCT ID:
NCT00489658
Status:
TERMINATED
Last Update Posted:
2007-06-21
First Post:
2007-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014353', 'term': 'Trypanosomiasis, African'}], 'ancestors': [{'id': 'D014352', 'term': 'Trypanosomiasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000518', 'term': 'Eflornithine'}], 'ancestors': [{'id': 'D009952', 'term': 'Ornithine'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'Because of unexpectedly reduced disease prevalence in the study area, a pragmatic decision was taken to terminate recruitment in March 2003.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2007-06-20', 'studyFirstSubmitDate': '2007-06-20', 'studyFirstSubmitQcDate': '2007-06-20', 'lastUpdatePostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure (death within 30 days of inclusion, or later if judged as related to Human African trypanosomiasis; termination of treatment due to adverse events; evidence of infection relapse at or after discharge, up to 24 months post discharge)', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Occurrence and severity of serious clinically apparent adverse events', 'timeFrame': 'treatment period and up to one month post discharge'}, {'measure': 'Occurrence and severity of biochemical (ALAT, creatinine, bilirubin) and haematological (abnormal total and differential leukocyte count, haemoglobin) adverse events', 'timeFrame': 'treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Human African trypanosomiasis', 'sleeping sickness', 'Trypanosoma brucei gambiense', 'combination', 'eflornithine', 'nifurtimox', 'Human African trypanosomiasis (sleeping sickness) due to Trypanosoma brucei gambiense in the late stage (stage 2 or meningo-encephalitic)'], 'conditions': ['Trypanosomiasis, African']}, 'referencesModule': {'references': [{'pmid': '17160135', 'type': 'BACKGROUND', 'citation': 'Priotto G, Fogg C, Balasegaram M, Erphas O, Louga A, Checchi F, Ghabri S, Piola P. Three drug combinations for late-stage Trypanosoma brucei gambiense sleeping sickness: a randomized clinical trial in Uganda. PLoS Clin Trials. 2006 Dec 8;1(8):e39. doi: 10.1371/journal.pctr.0010039.'}]}, 'descriptionModule': {'briefSummary': "This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 2 infection with Trypanosoma brucei gambiense diagnosed within the previous 14 days, as defined by either of the following: (i) Presence of trypanosomes in blood or lymph node fluid and WBC count in CSF \\> 5 / mm3, or (ii) Presence of trypanosomes in the CSF with any CSF WBC count\n* Residence in the study area\n* Written informed consent (to be obtained from parent/guardian for children under 18 years and patients with impaired cognition)\n\nExclusion Criteria:\n\n* Pregnancy or clinical history suggestive thereof\n* Weight \\< 10 Kg\n* History of any HAT treatment within the previous 24 months\n* Inability to undergo hospitalisation or attend follow-up visits during the 24 months following discharge\n* Severe anemia (Hb\\< 5g/dl)\n* Active tuberculosis (sputum positive)\n* HIV positive (if patient has been tested and results are known)\n* Severe renal or hepatic failure\n* Bacterial or cryptococcal meningitis\n* Other severe underlying diseases upon admission\n* Refugee status'}, 'identificationModule': {'nctId': 'NCT00489658', 'acronym': 'NECS', 'briefTitle': 'Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda', 'organization': {'class': 'OTHER', 'fullName': 'Epicentre'}, 'officialTitle': 'Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda', 'orgStudyIdInfo': {'id': 'NECS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Eflornithine plus Nifurtimox combination therapy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yumbe', 'state': 'Yumbe District', 'country': 'Uganda', 'facility': 'Yumbe District Hospital', 'geoPoint': {'lat': 3.46506, 'lon': 31.24689}}], 'overallOfficials': [{'name': 'Patrice Piola, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Epicentre'}, {'name': 'Gerardo Priotto, MD MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Epicentre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epicentre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Médecins Sans Frontières, France', 'class': 'OTHER'}]}}}