Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-31 @ 7:12 PM
Study NCT ID:
NCT01769612
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2013-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D007896', 'term': 'Leishmaniasis'}], 'ancestors': [{'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'noemailavailable@no.com', 'phone': '011-216-71-792-429', 'title': 'Afif Gen Salah, MD, PhD', 'organization': 'Institut Pasteur of Tunis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '48 hours after taking of samples', 'eventGroups': [{'id': 'EG000', 'title': 'CL Detect Rapid Test and Microsopy Samples', 'description': 'Samples taken to be evaluated in the CL Detect and Microscopy assays\n\nNo Intervention', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 0, 'seriousNumAtRisk': 168, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CL Detect Rapid Test', 'description': 'Data for CL Detect Rapid Test'}, {'id': 'OG001', 'title': 'Microscopy', 'description': 'Data for Micrscopy'}, {'id': 'OG002', 'title': 'Culture', 'description': 'Data for Culture results'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 1 hour after taking samples', 'description': 'Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results.\n\nNote: only data where results for all three methods were available were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CL Detect Rapid Test and Microsopy Samples', 'description': 'Samples taken to be evaluated in the CL Detect and Microscopy assays\n\nNo Intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '168 subjects were enrolled in the regions of Sidi Bouzid and Gafsa, Tunisia'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CL Detect Rapid Test and Microsopy Samples', 'description': 'Samples taken to be evaluated in the CL Detect and Microscopy assays\n\nNo Intervention'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '15.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'North African', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tunisia', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lesion Age', 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'spread': '22.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lesion Characteristics', 'classes': [{'title': 'Ulcerated', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}]}]}, {'title': 'Nobular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Secondary bacterial infection', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lesion Location', 'classes': [{'title': 'Abdomen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Arm', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': 'Back of head', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Face', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Foot', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Hand', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Leg', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2013-01-14', 'resultsFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-06', 'studyFirstPostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results', 'timeFrame': 'within 1 hour after taking samples', 'description': 'Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results.\n\nNote: only data where results for all three methods were available were included in the analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Leishmaniasis, Leishmania'], 'conditions': ['Skin Diseases, Parasitic']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.', 'detailedDescription': 'Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age and generally healthy\n* Subject able to give written informed consent\n* Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion:\n\n * less than 4 months in age\n * primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis\n * in a location suitable for collecting samples by dental broach, scraping, and aspiration\n* In the opinion of the investigator, the subject is capable of understanding and complying with the protocol\n\nExclusion Criteria:\n\n• Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome'}, 'identificationModule': {'nctId': 'NCT01769612', 'acronym': 'CL Detect™', 'briefTitle': 'Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'Evaluation of a Diagnostic Device, CL Detect Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia', 'orgStudyIdInfo': {'id': 'S-12-14'}, 'secondaryIdInfos': [{'id': 'A-15174.2b', 'type': 'OTHER', 'domain': 'HRPO'}, {'id': 'K141341', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'CL Detect Rapid Test and Microsopy Samples', 'description': 'Samples taken to be evaluated in the CL Detect and Microscopy assays', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'armGroupLabels': ['CL Detect Rapid Test and Microsopy Samples']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gafsa', 'state': 'Gafsa Governorate', 'country': 'Tunisia', 'facility': 'Primary Health Clinic', 'geoPoint': {'lat': 34.425, 'lon': 8.78417}}, {'city': 'Sidi Bouzid', 'state': 'Sidi Bouzid Governorate', 'country': 'Tunisia', 'facility': 'Primary Health Clinics', 'geoPoint': {'lat': 35.03823, 'lon': 9.48494}}], 'overallOfficials': [{'name': 'Afif Ben Salah, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Pasteur de Tunis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'collaborators': [{'name': 'InBios International, Inc.', 'class': 'INDUSTRY'}, {'name': 'Institut Pasteur of Tunis, Tunisia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}