[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100056915":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":27,"locations":43,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":27,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":27,"maxAge":27,"enrollmentInfo":74,"targetDuration":27,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},{"fullName":5,"class":6},"Office of Rare Diseases (ORD)","NIH",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","This group of infants is treated with a loading dose of oral pyrimethamine followed by a higher dose for the first two months then a lower dose for the remainder of the 12 months. Sulfadiazine and leucovorin calcium are also given orally for 12 months. The pyrimethamine loading dose is omitted if prior prenatal therapy was given.",[13,14,15,16],"Drug: Leucovorin calcium","Drug: Pyrimethamine","Drug: Spiramycin","Drug: Sulfadiazine",{"label":18,"type":10,"description":19,"interventionNames":20},"2","This group of infants is treated with a higher dose of oral pyrimethamine for the first 6 months and then the lower dose for the remainder of the 12 months. Sulfadiazine and leucovorin calcium are administered concurrently.",[13,14,15,16],[22,28,31,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Leucovorin calcium","See arm descriptions",[9,18],null,{"type":23,"name":29,"description":25,"armGroupLabels":30,"otherNames":27},"Pyrimethamine",[9,18],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":27},"Spiramycin","Spiramycin is administered before the fetal diagnosis is made.",[9,18],{"type":23,"name":36,"description":25,"armGroupLabels":37,"otherNames":27},"Sulfadiazine",[9,18],[39],{"name":40,"affiliation":41,"role":42},"Rima McLeod","University of Chicago","STUDY_CHAIR",[44],{"facility":41,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Chicago","Illinois","60637","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-87.65005,41.85003,{"lat":55,"lon":54},[58],{"name":40,"role":59,"phone":60,"phoneExt":27,"email":27},"CONTACT","773-834-4152",{"type":27,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":62,"oldOrganization":41},"Rima McLeod, MD Professor",[64],{"name":41,"class":65},"OTHER","100056915","phase-4-pyrimethamine-sulfadiazine-and-leucovorin-in-treating-patients-with-congenital-toxoplasmosis-100056915",false,"NCT00004317","Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis","Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis","PROTOCOL ENTRY CRITERIA:\n\n* Infants with congenital toxoplasmosis Toxoplasma gondii confirmed prior to age 2.5 months\n* Pregnant women with evidence of toxoplasma infection by clinical observation and amniotic fluid sampling\n* Acute infection acquired during gestation with evidence of fetal infection\n* Untreated older children entered as controls\n* Asymptomatic congenital toxoplasmosis\n* Age more than 1 year\n* No treatment within the first year of life\n* No more than 1 month of prior therapy","ALL",{"count":75,"type":76},600,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","RATIONALE: Congenital toxoplasmosis is an infection caused by the parasitic organism Toxoplasma gondii, and it may be passed from an infected mother to her unborn child. The mother may have mild symptoms or no symptoms; the fetus, however, may experience damage to the eyes, nervous system, skin, and ears. The newborn may have a low birth weight, enlarged liver and spleen, jaundice, anemia, petechiae, and eye damage. Giving the antiparasitic drugs pyrimethamine and sulfadiazine is standard treatment for congenital toxoplasmosis, but it is not yet known which regimen of pyrimethamine is most effective for the disease.\n\nPURPOSE: Randomized phase IV trial to determine which regimen of pyrimethamine is most effective when combined with sulfadiazine and leucovorin in treating patients who have congenital toxoplasmosis.",[82],"Toxoplasmosis",[84,85,86],"immunologic disorders and infectious disorders","rare disease","toxoplasmosis","2009-05-13",{"date":89,"type":76},"2009-05-14",{"date":91,"type":27},"2000-07",{"date":93,"type":76},"2030-12",{"name":95,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)",1]