Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-03 @ 9:23 PM
Study NCT ID:
NCT05443867
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2022-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045908', 'term': 'Mpox, Monkeypox'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018419', 'term': 'Primate Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D012376', 'term': 'Rodent Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Blood\n* Oropharyngeal swab\n* Anal swab (self-sampling)\n* Genital swab (self-sampling)\n* Saliva (self-sampling)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-28', 'studyFirstSubmitDate': '2022-06-21', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Presence of culturable virus in PCR positive samples from pre- or asymptomatic period', 'timeFrame': 'Until the end of the 3-week follow-up period', 'description': 'Presence of culturable virus in PCR positive samples from pre- or asymptomatic period'}], 'primaryOutcomes': [{'measure': 'Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample', 'timeFrame': 'Until 21 days after contact with index case', 'description': 'Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample'}], 'secondaryOutcomes': [{'measure': 'Rate of seroconversion in contacts, defined as a positive IgG (immunoglobulineG) for monkeypox', 'timeFrame': 'Until 21 days after contact with index case', 'description': 'To evaluate the rate of seroconversion in contacts (positive IgG for MPX) within 21 days after contact with index case'}, {'measure': 'Proportion of seroconversion in PCR positive contacts vs PCR negative contacts, defined as negative MPXV PCR in all samples until the end of the follow-up period', 'timeFrame': 'Until 21 days after contact with index case', 'description': 'Proportion of seroconversion in PCR positive contacts vs PCR negative contacts, defined as negative MPXV PCR in all samples until the end of the follow-up period'}, {'measure': 'Time to seroconversion overall, in symptomatic and asymptomatic contacts, and in PCR positive and negative cases', 'timeFrame': 'Until 21 days after contact with index case', 'description': 'Time to seroconversion overall, in symptomatic and asymptomatic contacts, and in PCR positive and negative cases'}, {'measure': 'Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR', 'timeFrame': 'Until 21 days after contact with index case', 'description': 'Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR'}, {'measure': 'Proportion of PCR positive participants developing symptoms within the follow-up period', 'timeFrame': 'Until 21 days after contact with index case', 'description': 'Proportion of PCR positive participants developing symptoms within the follow-up period'}, {'measure': 'Proportion of asymptomatic infections on number of contacts in follow-up. Asymptomatic infections are defined as contacts with positive MPXV PCR on any clinical sample, without development of any symptoms.', 'timeFrame': 'within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer', 'description': 'Proportion of asymptomatic infections on number of contacts in follow-up. Asymptomatic infections are defined as contacts with positive MPXV PCR on any clinical sample, without development of any symptoms within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer'}, {'measure': 'Time from MPXV PCR positivity in any sample to appearance of any symptom overall and per mode of transmission (close personal contact; anal, vaginal or oral receptive sexual contact; and insertive sexual contact)', 'timeFrame': 'at the end of the 3-week follow-up period', 'description': 'Time from MPXV PCR positivity in any sample to appearance of any symptom overall and per mode of transmission (close personal contact; anal, vaginal or oral receptive sexual contact; and insertive sexual contact)'}, {'measure': 'Time from MPXV PCR positivity in any sample to appearance of skin lesions', 'timeFrame': 'at the end of the 3-week follow-up period', 'description': 'Time from MPXV PCR positivity in any sample to appearance of skin lesions'}, {'measure': 'Time from confirmed exposure to first PCR positivity', 'timeFrame': 'at the end of the 3-week follow-up period', 'description': 'Time from confirmed exposure to first PCR positivity'}, {'measure': 'Time from confirmed exposure to appearance of any symptom', 'timeFrame': 'at the end of the 3-week follow-up period', 'description': 'Time from confirmed exposure to appearance of any symptom'}, {'measure': 'Time from confirmed exposure to appearance of skin lesions', 'timeFrame': 'at the end of the 3-week follow-up period', 'description': 'Time from confirmed exposure to appearance of skin lesions'}, {'measure': 'Description of the type of symptoms observed in monkeypox contacts', 'timeFrame': 'within 3 weeks after last exposure', 'description': 'Description of the type of symptoms observed in monkeypox contacts within 3 weeks after last exposure'}, {'measure': 'Frequency of symptoms observed in monkeypox contacts', 'timeFrame': 'within 3 weeks after last exposure', 'description': 'Frequency of symptoms observed in monkeypox contacts within 3 weeks after last exposure'}, {'measure': 'Timing of symptoms observed in monkeypox contacts', 'timeFrame': 'within 3 weeks after last exposure', 'description': 'Timing of symptoms observed in monkeypox contacts within 3 weeks after last exposure'}, {'measure': 'Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)', 'timeFrame': 'at the end of the 3-week follow-up period', 'description': 'Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)'}, {'measure': 'Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure', 'timeFrame': 'at the end of the 3-week follow-up period', 'description': 'Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure'}, {'measure': 'Number of contacts with the defined risk and protective factors', 'timeFrame': 'At baseline', 'description': 'Number of contacts with the defined risk and protective factors'}, {'measure': 'Proportion of presence of defined factors in PCR positive contacts.', 'timeFrame': 'Until the end of the 3-week follow-up period', 'description': 'Proportion of presence of defined factors in PCR positive contacts.'}, {'measure': 'Proportion of presence of defined factors in symptomatic PCR positive contacts', 'timeFrame': 'Until the end of the 3-week follow-up period', 'description': 'Proportion of presence of defined factors in symptomatic PCR positive contacts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Monkey Pox']}, 'referencesModule': {'references': [{'pmid': '37212312', 'type': 'DERIVED', 'citation': 'Brosius I, Van Dijck C, Coppens J, Vandenhove L, Bangwen E, Vanroye F, Verschueren J; ITM MPOX Study Group; Zange S, Bugert J, Michiels J, Bottieau E, Soentjens P, van Griensven J, Kenyon C, Arien KK, Van Esbroeck M, Vercauteren K, Liesenborghs L. Presymptomatic viral shedding in high-risk mpox contacts: A prospective cohort study. J Med Virol. 2023 May;95(5):e28769. doi: 10.1002/jmv.28769.'}]}, 'descriptionModule': {'briefSummary': 'Monkeypox (MPX) is a viral zoonosis, caused by the Monkeypox virus (MPXV), a DNA virus that belongs to the Orthopoxvirus genus and is closely related to the variola virus, the causative agent of smallpox. Until recently the spread of MPX was mainly confined to the Central African rainforest and to parts of West Africa. However, in May 2022, several cases of MPX were detected throughout Europe and Northern America, albeit with a different presentation than previously seen. Many questions remain on this new presentation of the disease: what the exact mode of transmission is, how contagious the virus really is and whether asymptomatic carriers exist. With this study the researchers aim to perform a close follow-up study of close contacts of MPX confirmed cases. Participants are recruited among high and very high risk contacts of confirmed monkeypox patients that presented to the ITM for diagnosis (index). Contacts that are asymptomatic (for symptoms compatible with MPXV infection according to national case definitions) at the time of recruitment will be enrolled. Contacts of the index case that are symptomatic at recruitment or become symptomatic during follow-up will be invited for sample collection at different timepoints until 21 days after contact as suspect cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are recruited among high and very high risk contacts of confirmed monkeypox patients that presented to the ITM for diagnosis (index). Contacts that are asymptomatic (for symptoms compatible with MPXV infection according to national case definitions) at the time of recruitment will be enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be a high risk or very high-risk contact of a laboratory confirmed monkeypox case, with:\n\n * Very high-risk contact:\n\n * Sexual partner(s)\n * Prolonged skin-to-skin contact while the patient had skin lesions\n * High risk contact\n\n * living in the same household or similar environment (e.g. camping, spending the night, etc.);\n * shared clothing, bedding, utensils, etc., while the patient had skin lesions\n * healthcare workers with unprotected contact (inadequate or no PPE)\n2. Last exposure to the monkeypox index case of less than 21 days ago\n3. Adult participants (≥ 18 years old) of any gender\n4. Written informed consent is obtained from the participant\n\nExclusion Criteria:\n\n1. Presenting with symptoms compatible with MPX:\n\n * an unexplained rash on any part of the body AND\n * one or more of the following symptoms: fever, headache, back pain, fatigue, lymphadenopathy (localised or generalised)\n2. Inability or unwillingness to comply with the proposed follow-up schedule'}, 'identificationModule': {'nctId': 'NCT05443867', 'acronym': 'MPX-Assess', 'briefTitle': 'Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Tropical Medicine, Belgium'}, 'officialTitle': 'Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS', 'orgStudyIdInfo': {'id': 'MPX-Assess'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MPX-Assess', 'description': 'Contacts of MPX index cases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Institute of Tropical Medicine Antwerp', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Laurens Liesenborghs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituut van Tropische Geneeskunde Antwerpen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Tropical Medicine, Belgium', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}