Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:54 AM
Study NCT ID:
NCT07456969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Malaria Diagnostic Data Collection in Ethiopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endpoint 1', 'timeFrame': 'From June 2026 to September 2026', 'description': 'Detection rate of the six predefined malaria VOC biomarkers in breath from PCR-confirmed malaria-positive and negative participants, as measured by TRACE-E.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malaria Fever']}, 'descriptionModule': {'briefSummary': "This project supports the development of a non-invasive diagnostic tool for malaria, focusing on validating the link between VOCs (volatile organic compounds) and malaria infection using thermodynamic sensors. This technology aims to provide rapid, painless alternatives to blood-based diagnostics, enabling malaria detection without invasive sampling.\n\nTrace Sensing has already identified six potential VOC biomarkers based on published literature specific for malaria. Two of these are part of the company's existing library and can already be detected in purified form by the TRACE-E device, while the others are under active evaluation. To confirm the suitability of the selected VOC biomarkers for diagnosing malaria and strengthen the detection algorithm, high-quality, robust clinical data from well-characterized biological specimens are required. In partnership with Gondar University in Ethiopia, breath samples will be collected from individuals (12 years and older) suspected of having malaria presenting at two health clinics. PCR performed on blood samples will serve as reference method to confirm infection status, while non-invasive clinical breath tests will be performed using the TRACE-E device.\n\nThe resulting data will confirm whether the six candidate malaria VOC biomarkers can be detected in patient breath, and if other VOC biomarkers can be detected as well. This study will therefore act as a malaria VOC biomarker confirmation study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of individuals aged 12 years and older presenting to outpatient clinics in Gondar, Ethiopia with suspected malaria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAged 12 years or older\n\nPresenting at the study site with fever (37.5 degrees and above)\n\nFreely agreeing to participate by providing informed consent (and assent, if applicable)\n\nExclusion Criteria:\n\nPresence of symptoms and signs of severe illness and/or central nervous system infections.\n\nPresenting with any condition that prevents adequate breath collection:\n\nAsthma\n\nChronic Obstructive Pulmonary Disease (COPD)\n\nSevere respiratory illness\n\nInability to follow instructions\n\nPatient lacking capacity to provide informed consent.\n\nPrior antimalarial treatment within the last 14 days.'}, 'identificationModule': {'nctId': 'NCT07456969', 'briefTitle': 'Non-invasive Malaria Diagnostic Data Collection in Ethiopia', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Innovative New Diagnostics, Switzerland'}, 'officialTitle': 'Data Collection Support for a Non-invasive Malaria Diagnostic Tool Using Volatile Organic Compounds (VOC) in Gondar, Ethiopia', 'orgStudyIdInfo': {'id': 'MA019'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andres De la Rossa, PhD', 'role': 'CONTACT', 'email': 'andres.delarossa@finddx.org', 'phone': '+41 798814705'}], 'overallOfficials': [{'name': 'Ayalew Jejaw Zeleke', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Gondar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Innovative New Diagnostics, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}