[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571679":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":147,"collaborators":149,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":187,"sex":188,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":25,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":203,"overallStatus":33,"whyStopped":25,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},{"fullName":5,"class":6},"NICHD Global Network for Women's and Children's Health","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral nitrofurantoin monohydrate\u002Fmacrocrystals","EXPERIMENTAL","Pregnant individuals with AB randomized to receive a 7-day course of oral NM\u002FM 100 mg twice daily (total of 14 doses)",[13],"Drug: Oral nitrofurantoin monohydrate\u002Fmacrocrystals",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Pregnant individuals with AB randomized to a receive a 7-day course of oral placebo 100 mg twice daily (total of 14 doses)",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","7-day course of oral nitrofurantoin monohydrate\u002Fmacrocrystals 100 mg twice daily (total of 14 doses)",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"OTHER","7-day course of oral placebo 100 mg twice daily (total of 14 doses)",[15],[31,53,70,86,103,117,132],{"facility":32,"status":33,"city":34,"state":35,"zip":25,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Icddr,B","RECRUITING","Dhaka","Bangladesh","BD",{"type":38,"coordinates":39},"Point",[40,41],90.40744,23.7104,{"lat":41,"lon":40},[44,49,51],{"name":45,"role":46,"phone":47,"phoneExt":25,"email":48},"Rashidul Haque, MD","CONTACT","(880-2)9827001-10","rhaque@icddrb.org",{"name":45,"role":50,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":52,"role":50,"phone":25,"phoneExt":25,"email":25},"SK Masum Billah",{"facility":54,"status":55,"city":56,"state":57,"zip":25,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Kinshasa School of Public Health","NOT_YET_RECRUITING","Kinshasa","DRC","Democratic Republic of the Congo","CD",{"type":38,"coordinates":61},[62,63],15.31357,-4.32758,{"lat":63,"lon":62},[66,69],{"name":67,"role":46,"phone":25,"phoneExt":25,"email":68},"Antoinette Tshefu, MD, PhD, MPH","antotshe@yahoo.com",{"name":67,"role":50,"phone":25,"phoneExt":25,"email":25},{"facility":71,"status":55,"city":72,"state":73,"zip":25,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Institue for Nutrition of Central America and Panama (INCAP)","Guatemala City","Departamento de Guatemala","Guatemala","GT",{"type":38,"coordinates":77},[78,79],-90.51327,14.64072,{"lat":79,"lon":78},[82,85],{"name":83,"role":46,"phone":25,"phoneExt":25,"email":84},"Manolo Mazariegos, MD, MPH","mmaziergos@incap.org",{"name":83,"role":50,"phone":25,"phoneExt":25,"email":25},{"facility":87,"status":33,"city":88,"state":89,"zip":25,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"KLE Academy of Higher Education and Research","Belagavi","Karnataka","India","IN",{"type":38,"coordinates":93},[94,95],74.50447,15.85212,{"lat":95,"lon":94},[98,102],{"name":99,"role":46,"phone":100,"phoneExt":25,"email":101},"Shivaprasad S Goudar, MD, MHPE","919448126371","sgoudar@jnmc.edu",{"name":99,"role":50,"phone":25,"phoneExt":25,"email":25},{"facility":104,"status":55,"city":105,"state":106,"zip":25,"country":90,"countryCode":91,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Lata Medical Research Foundation","Nagpur","Maharashtra",{"type":38,"coordinates":108},[109,110],79.08491,21.14631,{"lat":110,"lon":109},[113,116],{"name":114,"role":46,"phone":25,"phoneExt":25,"email":115},"Archana Patel, MD, DNB, MSCE, PhD","Dr_apatel@yahoo.com",{"name":114,"role":50,"phone":25,"phoneExt":25,"email":25},{"facility":118,"status":55,"city":119,"state":120,"zip":25,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Aga Khan University","Karachi","Pakistan","PK",{"type":38,"coordinates":123},[124,125],67.0104,24.8608,{"lat":125,"lon":124},[128,131],{"name":129,"role":46,"phone":25,"phoneExt":25,"email":130},"Sarah Saleem, MD","sarah.saleem@aku.edu",{"name":129,"role":50,"phone":25,"phoneExt":25,"email":25},{"facility":133,"status":55,"city":134,"state":135,"zip":25,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"University Teaching Hospital","Lusaka","Zambia","ZM",{"type":38,"coordinates":138},[139,140],28.28713,-15.40669,{"lat":140,"lon":139},[143,146],{"name":144,"role":46,"phone":25,"phoneExt":25,"email":145},"Elwyn Chomba, MBChB, DCH, MRCP","chombaelwyn@gmail.com",{"name":144,"role":50,"phone":25,"phoneExt":25,"email":25},{"type":148,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[150,152,154,156,158,160,162,164,166,168,169,171,173,174,176],{"name":151,"class":27},"RTI International",{"name":153,"class":27},"University of Virginia",{"name":155,"class":27},"University of Alabama at Birmingham",{"name":157,"class":27},"Thomas Jefferson University",{"name":159,"class":27},"Columbia University",{"name":161,"class":27},"Boston University",{"name":163,"class":27},"University of Colorado, Denver",{"name":165,"class":27},"University of North Carolina, Chapel Hill",{"name":167,"class":27},"International Centre for Diarrhoeal Disease Research, Bangladesh",{"name":54,"class":27},{"name":170,"class":27},"Institute of Nutrition of Central America and Panama",{"name":172,"class":27},"Lata Medical Research Foundation, Nagpur",{"name":118,"class":27},{"name":175,"class":27},"University Teaching Hospital, Lusaka, Zambia",{"name":177,"class":178},"KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India","UNKNOWN","100571679","phase-3-asymptomatic-bacteriuria-in-pregnancy-in-low--and-middle-income-countries-100571679",false,"NCT06723392","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research","ABLE","Inclusion Criteria:\n\nIndividuals who meet the following criteria are eligible for randomization:\n\n* Enrolled in GN MNHR\n* Established pregnancy ≥12 and ≤20 weeks GA by last menstrual period and\u002For clinical assessment and\u002For ultrasonography\n* Age: 18 years (or lower limit age eligible\\*) to 49 years\n\n  \\* Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites will require individuals to be at least 18 years of age. The investigators will adhere to local regulations.\n* Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up\n* Able to provide informed consent\n* Presence of a single bacterial isolate (\\>105 colony forming unit (CFU)\u002FmL) in urine at enrollment\n* Intent to remain in study area for at least 42 days PP\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria are not eligible for randomization:\n\n* Gestational age \\\u003C12 weeks or \\>20 weeks\n* Received treatment with any antibiotic within 14 days before screening visit\n* Current symptoms of UTI\n* History of allergy to nitrofurantoin\n* Pregnancy loss \u002F miscarriage prior to randomization\n* Currently taking magnesium-containing antacid\n* Any illness \u002F condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment\n* Enrollment in another trial that per the study MOP will impact this trial",true,"FEMALE","18 Years","49 Years",{"count":192,"type":193},1134,"ESTIMATED","INTERVENTIONAL",[196],"PHASE3","This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \\[End preventable deaths of newborns and children under 5 years of age\\] by examining the potential impact of this practice to reduce the incidence of SVN\u002FSB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).",[199,200,201,202],"Preterm Birth","Small for Gestational Age (SGA)","Stillbirth","Bacteriuria (Asymptomatic) in Pregnancy",[204,205,206,207,208,209,210,211,35,90,120,212,135,74],"asymptomatic bacteriuria","small vulnerable newborn","preterm birth","small for gestational agea","still birth","SVN\u002FSB","oral nitrofurantoin monohydrate\u002Fmacrocrystals","Global Network","Democratic Republic of Congo","2026-01-20",{"date":215,"type":216},"2026-01-22","ACTUAL",{"date":218,"type":216},"2025-12-08",{"date":220,"type":193},"2028-11",{"name":5,"class":6},7]