[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100286902":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":43,"locations":50,"responsibleParty":72,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":48,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":52,"whyStopped":48,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"St. Joseph's Hospital and Medical Center, Phoenix","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Nasal Care","PLACEBO_COMPARATOR","One dose of preoperative intravenous (iv) antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Postoperative antibiotics: Study participants will receive one dose only of postoperative intravenous antibiotic (e.g., cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg \\[cephalosporin allergic patients\\]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Placebo PO BID (twice daily) will commence on the morning of postoperative day 1 and continue for 7 days.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Nasal Care + Oral Antibiotics","EXPERIMENTAL","One dose of preoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg) will be administered within 60 minutes of start of surgery. Repeat intraoperative dosing of antibiotics is permitted if length of surgery exceeds recommended dosing interval. IV antibiotic dosing schedules: Cefazolin 1 gm iv Q6 hr -or- Cefuroxime 1.5gm iv Q8 hr -or- Clindamycin 300 mg iv Q12 hr. Participants will receive 1 dose only of postoperative iv antibiotic (cefazolin 1gm, or cefuroxime 1.5gm, or clindamycin 300mg \\[cephalosporin allergic patients\\]) according to the recommended dosing schedule described above. This dose of antibiotics is in addition to the preoperative dose. Oral antibiotics will commence on the morning of postoperative day 1; this group will receive oral antibiotics (cefdinir \\[Omnicef®\\] 300 mg PO BID or trimethoprim\u002Fsulfamethoxazole \\[Bactrim DS™\\] PO BID for cephalosporin intolerant patients) for 7 days.",[19],"Drug: Oral Antibiotics cefdinir or trimethoprim\u002Fsulfamethoxazole",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Placebo","PO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.",[9],[27],"inert substance",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Oral Antibiotics cefdinir or trimethoprim\u002Fsulfamethoxazole","Oral antibiotics (cefdinir \\[Omnicef®\\] 300 mg PO BID or trimethoprim\u002Fsulfamethoxazole \\[Bactrim DS™\\] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.",[15],[33,34],"Omnicef","Bactrim DS™ cephalosporin intolerant patients",[36,40],{"name":37,"affiliation":38,"role":39},"Andrew Little, MD","Barrow Brain and Spine","STUDY_CHAIR",{"name":41,"affiliation":42,"role":39},"James Evans, MD","Thomas Jefferson University",[44],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Heidi Jahnke, RN, MSN","CONTACT","602-406-6976",null,"heidi.jahnke@dignityhealth.org",[51],{"facility":38,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Phoenix","Arizona","85013","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-112.07404,33.44838,{"lat":62,"lon":61},[65,67,69,70],{"name":66,"role":46,"phone":47,"phoneExt":48,"email":49},"Heidi Jahnke, RN,MSN",{"name":37,"role":68,"phone":48,"phoneExt":48,"email":48},"PRINCIPAL_INVESTIGATOR",{"name":41,"role":68,"phone":48,"phoneExt":48,"email":48},{"name":71,"role":68,"phone":48,"phoneExt":48,"email":48},"Varun Kshettry, MD",{"type":68,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Pam Dewey","Research Manager",[76,77],{"name":42,"class":6},{"name":78,"class":6},"The Cleveland Clinic","100286902","phase-4-prophylactic-oral-antibiotics-on-sinonasal-outcomes-following-endoscopic-transsphenoidal-surgery-for-pituitary-lesions-100286902",false,"NCT03014687","Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions","A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Impact of Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions","POET","Inclusion Criteria:\n\n* Adult patient undergoing endoscopic surgery for resection of pituitary tumors for nonfunctioning adenoma, acromegaly, or prolactinoma\n* Adults \\>18 and \\\u003C85 years of age\n* English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales\n* Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable\n\nExclusion Criteria:\n\n* Anaphylaxis\u002Fintolerance to the study drugs\n* Cirrhosis, hepatitis\n* Any solid organ transplant or bone marrow transplant. And any patient felt to be immunocompromised by the investigators\n* Renal failure on dialysis\n* Any subject who is unwilling or unable to sign informed consent for the study\n* Pregnancy\n* Incarcerated patients\n* Cushing's disease\n* Rathke's Cleft cyst or pituitary cyst\n* History of chronic sinusitis\n* Anticipated use of nasal splints\n* Anticipated use of nasal septal flap\n* Active sinusitis\n* Nasal polyps\n* Previous sinus surgery\n* Concurrent antibiotics for another indication (i.e., urinary tract infection)\n* Immunodeficiency","ALL","18 Years","84 Years",{"count":91,"type":92},116,"ESTIMATED","INTERVENTIONAL",[95],"PHASE4","To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection (sinusitis), and helps mucosal healing in the nasal passages.",[98,99],"Antibiotics","Pituitary Adenoma",[101],"transsphenoidal surgery","2018-08-13",{"date":104,"type":105},"2018-08-15","ACTUAL",{"date":107,"type":105},"2017-07-01",{"date":109,"type":92},"2019-07",{"name":5,"class":6},1]