Nctid:
NCT06617260
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITHOUT_DNA", "description"=>"Rectovaginal swabs"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"FAMILY_BASED"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>1000}, "targetDuration"=>"1 Year", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2024-02-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-02-28", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-02-28", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Antimicrobial resistance", "timeFrame"=>"12 months", "description"=>"Ultimately, the goal of the LWAPA study is to better understand perinatal transmission of AMR in order to inform prevention measures"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Antimicrobial"], "conditions"=>["Drug Resistance, Microbial"]}, "descriptionModule"=>{"briefSummary"=>"In 2022, in collaboration between the Botswana Ministry of Health (MOH), the U.S. Centers for Disease Control \\& Prevention, and the Botswana-UPenn Partnership (BUP), a program was launched called, \"Surveillance of Healthcare-associated infections \\& Antimicrobial Resistance\", or \"SHARE\". The aims of SHARE are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs, leveraging data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of hospital infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats.", "detailedDescription"=>"The Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition (LWAPA) study will assess the extent of perinatally-acquired MDROs and GBS, exploring factors influencing both maternal and neonatal colonization and better understanding the long-term outcomes in families affected by MDRO colonization.\n\nBy collecting samples at critical time points (e.g. during labour, after delivery, sequentially in the hospital, and then 3, 6, 9, and 12 months of age, the LWAPA study aims to identify modifiable factors influencing colonization risk. The results from this study can help inform and operationalize infection prevention measures which are poised to reduce the incidence of healthcare-associated infections and other poor health outcomes.\n\nIn Setswana, 'lwapa' means 'home' or 'family', which captures how this study aims to understand healthcare-associated AMR is impacting households and communities."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"36 weeks", "genderBased"=>true, "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:\n\n* Pre-term labor (24-36 weeks gestation)\n* Pre-eclampsia\n* Post-dates (\\>41 weeks gestation) The rationale for recruiting these mothers is that there is a high probability of having a baby who will ultimately be admitted to the NNU", "genderDescription"=>"Pre partum mothers", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\nPre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:\n\n* Pre-term labor (24-36 weeks gestation)\n* Pre-eclampsia\n* Post-dates (\\>41 weeks gestation)-\n\nExclusion Criteria:\n\nMothers/babies who have been admitted for more than 96 hours will be excluded"}, "identificationModule"=>{"nctId"=>"NCT06617260", "acronym"=>"LWAPA", "briefTitle"=>"Longitudinal FolloW-up of Antimicrobial Resistance From Perinatal Acquisition (LWAPA): A SHARE Study ASSESSING AND PREVENTING Antimicrobial Resistance in the Perinatal Period", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Pennsylvania"}, "officialTitle"=>"Longitudinal FolloW-up of Antimicrobial Resistance From Perinatal Acquisition (LWAPA): A SHARE Study ASSESSING AND PREVENTING Antimicrobial Resistance in the Perinatal Period", "orgStudyIdInfo"=>{"id"=>"855283"}, "secondaryIdInfos"=>[{"id"=>"Antimicrobial resistance(AMR),", "type"=>"OTHER", "domain"=>"the U.S. Centers for Disease Control & Prevention"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Neonates and mothers", "description"=>"Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:\n\n* Pre-term labor (24-36 weeks gestation)\n* Pre-eclampsia\n* Post-dates (\\>41 weeks gestation) The rationale for recruiting these mothers is that there is a high probability of having a baby who will ultimately be admitted to the NNU"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"267", "city"=>"Gaborone", "country"=>"Botswana", "facility"=>"Princess Marina Hospital", "geoPoint"=>{"lat"=>-24.65451, "lon"=>25.90859}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Pennsylvania", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor of Medicine", "investigatorFullName"=>"Ebbing Lautenbach", "investigatorAffiliation"=>"University of Pennsylvania"}}}}
