[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06654752":3,"trial-entities:NCT06654752":552,"trial-summary:NCT06654752":557},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":48,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":60,"locations":63,"central_contacts":533,"overall_officials":538,"references":543,"see_also_links":548},"NCT06654752","STOP PEDS RCT","Streamlined Treatment of Pulmonary Exacerbations in Pediatrics","Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial (STOP PEDS RCT)","RECRUITING","2029-02-28","2026-07","2026-08-03","2024-12-01","University of Washington, the Collaborative Health Studies Coordinating Center","OTHER",true,"The STOP PEDS RCT is a multicenter, parallel, open label randomized controlled trial evaluating the long-term (one year) and short-term safety and efficacy of two antibiotic treatment strategies for the management of outpatient pulmonary exacerbations (PEx) in the pediatric CF population.","The STOP PEDS pilot study demonstrated that a randomized trial of treatment strategies for mild pulmonary exacerbations (PEx) in children with CF was feasible and that assignment to a tailored therapy arm (defined below) may reduce antibiotic exposure.\n\nBased on the research priorities identified by CF families and clinicians and the results of the pilot study, the STOP PEDS RCT is a multicenter, parallel, open label randomized controlled trial evaluating the long-term (one year) and short-term safety and efficacy of two antibiotic treatment strategies for the management of outpatient PEx in the pediatric CF population. The two treatment arms are immediate antibiotics and tailored therapy. In both arms, participants will be instructed to increase airway clearance at the onset of an eligible PEx. In the immediate antibiotics arm, they will also begin 14 days of oral antibiotics preselected by their primary CF providers, while in the tailored therapy they will only begin antibiotics if prespecified criteria for worsening symptoms or failure to improve are met.\n\nThe STOP PEDS study will enroll three cohorts. In the main cohort, children ages 6-18 on highly effective modulator therapy (HEMT) will be enrolled when well and followed for 12 months. Participants will be randomly assigned to a treatment arm and maintain that treatment assignment for all subsequent eligible PEx during their 12-month enrollment period. Two additional pilot cohorts, the preschool cohort (children ages 3 to 5 on HEMT) and the non-HEMT cohort (children ages 6-18 not eligible for HEMT), will be enrolled in parallel pilot studies. Participants will enroll when well and be followed through one randomized PEx.\n\nParticipants in the STOP PEDS RCT at selected sites will have the opportunity to enroll in optional substudies if eligible. These substudies include:\n\n* Clinic throat swab substudy\n* Home throat and nasal swab substudy\n* Remote monitoring substudy (Home monitoring of lung function, vital signs, activity and sleep)",[19],"Cystic Fibrosis",[21,22,23,24],"cystic fibrosis","oral antibiotics","pulmonary exacerbation","pediatric","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},430,"ESTIMATED",[33,38],{"type":14,"name":34,"description":35,"armGroupLabels":36},"Immediate Oral Antibiotics","Increase airway clearance and start 14 days of preselected oral antibiotics right away",[37],"Immediate Antibiotics",{"type":14,"name":39,"description":40,"armGroupLabels":41},"Tailored Treatment: Oral Antibiotics only if Additional Treatment needed","Increase airway clearance and start preselected oral antibiotics later if symptoms get worse or do not get better according to prespecified criteria",[42],"Tailored Therapy",[44],{"measure":45,"description":46,"timeFrame":47},"One-year change in pulmonary function by spirometry-measured ppFEV1","Compare the difference in pulmonary function between arms by evaluating change in spirometry-measured percent predicted forced expiratory volume (ppFEV1). A spirometry test measures the amount of air a person can forcibly exhale after a deep breath (forced vital capacity, or FVC) and the amount of air they can exhale in one second (forced expiratory volume in one second, or FEV1). A lower measured value compared to the reference value indicates lung disease.","1 year",[49],{"measure":50,"description":51,"timeFrame":47},"One-Year change in pulmonary function by LCI","Compare the difference in pulmonary function between arms by evaluating change in Lung Clearance Index (LCI). LCI increases when there is lung disease, which causes ventilation inhomogeneity. LCI is calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity \\[FRC\\]) required to reduce end-tidal nitrogen concentration to 1\u002F40th of the original level.","ALL","3 Years","18 Years",false,{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Inclusion Criteria:\n\n1. Age\n\n   1. For main cohort and non-HEMT cohort: age 6 to \\\u003C19 years\n   2. For preschool cohort: age 3 to \\\u003C6 years\n2. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:\n\n   1. sweat chloride ≥ 60 mEq\u002Fliter\n   2. two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene\n3. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study\n4. Highly Effective Modulator Therapy\n\n   1. For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment\n   2. For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months\n5. For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry\n6. For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations\n7. Ability to receive text messages and access the internet\n\nExclusion Criteria:\n\n1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data\n2. Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report\n3. Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report\n4. History of solid organ transplant\n5. History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment\n6. Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment\n7. Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment\n8. Treatment with chronic oral antibiotics other than azithromycin at enrollment\n9. Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment",[61,62],"CHILD","ADULT",[64,82,96,110,123,137,151,165,179,196,210,224,238,252,266,276,290,303,317,331,345,359,376,389,403,417,430,444,458,477,491,504,519],{"facility":65,"status":8,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":79},"The Children's Hospital Alabama & University of Alabama at Birmingham","Birmingham","Alabama","35233","United States",[71,76],{"name":72,"role":73,"phone":74,"email":75},"Valerie Tarn","CONTACT","205-638-5134","vtarn@uabmc.edu",{"name":77,"role":78},"Christopher Fowler, MD","PRINCIPAL_INVESTIGATOR",{"lat":80,"lon":81},33.52066,-86.80249,{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":69,"contacts":87,"geoPoint":93},"Tucson Cystic Fibrosis Center","Tucson","Arizona","85713",[88,91],{"name":89,"role":73,"email":90},"Elizabeth (Lisa) Ryan","elizabethryan@arizona.edu",{"name":92,"role":78},"Cori Daines, MD",{"lat":94,"lon":95},32.22174,-110.92648,{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":69,"contacts":101,"geoPoint":107},"Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic","Los Angeles","California","90027",[102,105],{"name":103,"role":73,"email":104},"Jared Lopez, BA","jalopez@chla.usc.edu",{"name":106,"role":78},"Martha McKinney, MD",{"lat":108,"lon":109},34.05223,-118.24368,{"facility":111,"status":8,"city":112,"state":99,"zip":113,"country":69,"contacts":114,"geoPoint":120},"Stanford University","Palo Alto","94304",[115,118],{"name":116,"role":73,"email":117},"Tina Conti, BSRC, RRT, RRT-NPS, C-NPT","tconti@stanford.edu",{"name":119,"role":78},"Lori WaiHang Lee, MD",{"lat":121,"lon":122},37.44188,-122.14302,{"facility":124,"status":125,"city":126,"state":99,"zip":127,"country":69,"contacts":128,"geoPoint":134},"Rady Children's Hospital at University of California San Diego","NOT_YET_RECRUITING","San Diego","92123",[129,132],{"name":130,"role":73,"email":131},"Lisa Ramos, CRC","lramosvallejo@health.ucsd.edu",{"name":133,"role":78},"Kathryn Akong, MD",{"lat":135,"lon":136},32.71571,-117.16472,{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":69,"contacts":142,"geoPoint":148},"Children's Hospital of Colorado","Aurora","Colorado","80045",[143,146],{"name":144,"role":73,"email":145},"Mary Cross","Mary.Cross@childrenscolorado.org",{"name":147,"role":78},"Jordana Hoppe, MD",{"lat":149,"lon":150},39.72943,-104.83192,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":69,"contacts":156,"geoPoint":162},"Children's Healthcare of Atlanta & Emory University","Atlanta","Georgia","30322",[157,160],{"name":158,"role":73,"email":159},"Joy Dangerfield","jdanger@emory.edu",{"name":161,"role":78},"Ajay Kasi, MD",{"lat":163,"lon":164},33.749,-84.38798,{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":69,"contacts":170,"geoPoint":176},"Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University","Chicago","Illinois","60611",[171,174],{"name":172,"role":73,"email":173},"Larissa Rugg","lrugg@luriechildrens.org",{"name":175,"role":78},"Maria Dowell, MD",{"lat":177,"lon":178},41.85003,-87.65005,{"facility":180,"status":8,"city":181,"state":182,"zip":183,"country":69,"contacts":184,"geoPoint":193},"Riley Hospital for Children & Indiana University","Indianapolis","Indiana","46202",[185,188,191],{"name":186,"role":73,"email":187},"Misty Thompson","misthomp@iu.edu",{"name":189,"role":73,"email":190},"Lisa Bendy","lbendy@iu.edu",{"name":192,"role":78},"D. B. Sanders, MD, MS",{"lat":194,"lon":195},39.76838,-86.15804,{"facility":197,"status":8,"city":198,"state":199,"zip":200,"country":69,"contacts":201,"geoPoint":207},"University of Iowa","Iowa City","Iowa","52242",[202,205],{"name":203,"role":73,"email":204},"Mary Teresi","mary-teresi@uiowa.edu",{"name":206,"role":78},"Anthony Fischer, MD",{"lat":208,"lon":209},41.66113,-91.53017,{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":69,"contacts":215,"geoPoint":221},"Johns Hopkins Hospital, Johns Hopkins University","Baltimore","Maryland","21287",[216,219],{"name":217,"role":73,"email":218},"Jamelia Maynard","jmaynar8@jhmi.edu",{"name":220,"role":78},"Peter Mogayzel, MD, PhD, MBA",{"lat":222,"lon":223},39.29038,-76.61219,{"facility":225,"status":8,"city":226,"state":227,"zip":228,"country":69,"contacts":229,"geoPoint":235},"Boston Children's Hospital & Harvard University","Boston","Massachusetts","02115",[230,233],{"name":231,"role":73,"email":232},"Monica Ulles","monica.ulles@childrens.harvard.edu",{"name":234,"role":78},"Gregory Sawicki, MD",{"lat":236,"lon":237},42.35843,-71.05977,{"facility":239,"status":8,"city":240,"state":241,"zip":242,"country":69,"contacts":243,"geoPoint":249},"University of Michigan Health System","Ann Arbor","Michigan","48109-5212",[244,247],{"name":245,"role":73,"email":246},"Dawn Kruse","dmkruse@med.umich.edu",{"name":248,"role":78},"Samya Nasr, MD",{"lat":250,"lon":251},42.27756,-83.74088,{"facility":253,"status":8,"city":254,"state":255,"zip":256,"country":69,"contacts":257,"geoPoint":263},"Children's Hospitals and Clinics of Minnesota","Minneapolis","Minnesota","55404",[258,261],{"name":259,"role":73,"email":260},"Danniella Balangoy","Danniella.Balangoy@childrensmn.org",{"name":262,"role":78},"Brooke Moore, MD",{"lat":264,"lon":265},44.97997,-93.26384,{"facility":267,"status":8,"city":254,"state":255,"zip":268,"country":69,"contacts":269,"geoPoint":275},"The Minnesota Cystic Fibrosis Center & University of Minnesota","55455",[270,273],{"name":271,"role":73,"email":272},"Alyssa Perry","ahperry@umn.edu",{"name":274,"role":78},"Samuel Goldfarb, MD",{"lat":264,"lon":265},{"facility":277,"status":8,"city":278,"state":279,"zip":280,"country":69,"contacts":281,"geoPoint":287},"Children's Mercy Hospital","Kansas City","Missouri","64108",[282,285],{"name":283,"role":73,"email":284},"Jana Lomonte","jblomonte@cmh.edu",{"name":286,"role":78},"Hugo Escobar, MD",{"lat":288,"lon":289},39.09973,-94.57857,{"facility":291,"status":8,"city":292,"state":279,"zip":293,"country":69,"contacts":294,"geoPoint":300},"St. Louis Children's Hospital & Washington University School of Medicine","St Louis","63110",[295,298],{"name":296,"role":73,"email":297},"Emily Schulte, RN, BSN","e.burns@wustl.edu",{"name":299,"role":78},"Jessica Pittman, MD",{"lat":301,"lon":302},38.62727,-90.19789,{"facility":304,"status":8,"city":305,"state":306,"zip":307,"country":69,"contacts":308,"geoPoint":314},"University of Rochester Medical Center Strong Memorial","Rochester","New York","14642",[309,312],{"name":310,"role":73,"email":311},"Barbara Johnson, RN","Barbara_johnson@urmc.rochester.edu",{"name":313,"role":78},"Matthew McGraw, MD",{"lat":315,"lon":316},43.15478,-77.61556,{"facility":318,"status":8,"city":319,"state":320,"zip":321,"country":69,"contacts":322,"geoPoint":328},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27514",[323,326],{"name":324,"role":73,"email":325},"Caroline Flowers, CRC","caroline_flowers@med.unc.edu",{"name":327,"role":78},"Jennifer Goralski, MD",{"lat":329,"lon":330},35.9132,-79.05584,{"facility":332,"status":8,"city":333,"state":334,"zip":335,"country":69,"contacts":336,"geoPoint":342},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",[337,340],{"name":338,"role":73,"email":339},"Sharon Kadon, RN, BSN, CPN","sharon.kadon@cchmc.org",{"name":341,"role":78},"Gary McPhail, MD",{"lat":343,"lon":344},39.12711,-84.51439,{"facility":346,"status":8,"city":347,"state":348,"zip":349,"country":69,"contacts":350,"geoPoint":356},"Oregon Health & Science University","Portland","Oregon","97239-3098",[351,354],{"name":352,"role":73,"email":353},"Pierce Nusbaum","nusbaum@ohsu.edu",{"name":355,"role":78},"Kelvin MacDonald, MD",{"lat":357,"lon":358},45.52345,-122.67621,{"facility":360,"status":8,"city":361,"state":362,"zip":363,"country":69,"contacts":364,"geoPoint":373},"Children's Hospital of Philadelphia & University of Pennsylvania","Philadelphia","Pennsylvania","19104",[365,368,371],{"name":366,"role":73,"email":367},"Matthew Gari","garim@chop.edu",{"name":369,"role":73,"email":370},"Erin Donnelly","donnellye4@chop.edu",{"name":372,"role":78},"Clement Ren, MD, MBA",{"lat":374,"lon":375},39.95238,-75.16362,{"facility":377,"status":8,"city":378,"state":362,"zip":379,"country":69,"contacts":380,"geoPoint":386},"Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center","Pittsburgh","15224",[381,384],{"name":382,"role":73,"email":383},"Adrienne DeRicco, RN","adrienne.dericco2@upmc.edu",{"name":385,"role":78},"Daniel Weiner, MD",{"lat":387,"lon":388},40.44062,-79.99589,{"facility":390,"status":8,"city":391,"state":392,"zip":393,"country":69,"contacts":394,"geoPoint":400},"Medical University of South Carolina","Charleston","South Carolina","29425",[395,398],{"name":396,"role":73,"email":397},"Sarah Shine","shinesa@musc.edu",{"name":399,"role":78},"Sylvia E Szentpeter, MD",{"lat":401,"lon":402},32.77632,-79.93275,{"facility":404,"status":8,"city":405,"state":406,"zip":407,"country":69,"contacts":408,"geoPoint":414},"University of Texas Southwestern & Children's Health","Dallas","Texas","75235",[409,412],{"name":410,"role":73,"email":411},"Lindsay Allen, CRC","Lindsay.Allen@utsouthwestern.edu",{"name":413,"role":78},"Preeti Sharma, MD",{"lat":415,"lon":416},32.78306,-96.80667,{"facility":418,"status":8,"city":419,"state":406,"zip":420,"country":69,"contacts":421,"geoPoint":427},"Texas Children's Hospital & Baylor College of Medicine","Houston","77030",[422,425],{"name":423,"role":73,"email":424},"Mayel Yepez","Mayel.YepezDonado@bcm.edu",{"name":426,"role":78},"Fadel Ruiz, MD",{"lat":428,"lon":429},29.76328,-95.36327,{"facility":431,"status":8,"city":432,"state":433,"zip":434,"country":69,"contacts":435,"geoPoint":441},"Vermont Children's Hospital & University of Vermont Medical Center","Burlington","Vermont","05401",[436,439],{"name":437,"role":73,"email":438},"Zachary Dichard","Zachary.Dichard@uvmhealth.org",{"name":440,"role":78},"Thomas Lahiri, MD",{"lat":442,"lon":443},44.47588,-73.21207,{"facility":445,"status":8,"city":446,"state":447,"zip":448,"country":69,"contacts":449,"geoPoint":455},"Virginia Commonwealth University","Richmond","Virginia","23298",[450,453],{"name":451,"role":73,"email":452},"Aleksander Subotic, CRC","aleksandar.subotic@vcuhealth.org",{"name":454,"role":78},"Andrew T. Barber, MD",{"lat":456,"lon":457},37.55376,-77.46026,{"facility":459,"status":8,"city":460,"state":461,"zip":462,"country":69,"contacts":463,"geoPoint":474},"Seattle Children's Hospital","Seattle","Washington","98105",[464,468,472],{"name":465,"role":73,"phone":466,"email":467},"Alan Genatossio","206-987-3317","alan.genatossio@seattlechildrens.org",{"name":469,"role":73,"phone":470,"email":471},"Marissa Nelson, CRC","206-987-3921","marissa.nelsen@seattlechildrens.org",{"name":473,"role":78},"Margaret Rosenfeld, MD",{"lat":475,"lon":476},47.60621,-122.33207,{"facility":478,"status":8,"city":479,"state":480,"zip":481,"country":69,"contacts":482,"geoPoint":488},"University of Wisconsin","Madison","Wisconsin","53792",[483,486],{"name":484,"role":73,"email":485},"Nikki Cole, BS, RRT, CCRC","ndondlinger@wisc.edu",{"name":487,"role":78},"Hara Levy, MD",{"lat":489,"lon":490},43.07305,-89.40123,{"facility":492,"status":8,"city":493,"state":480,"zip":494,"country":69,"contacts":495,"geoPoint":501},"Children's Wisconsin & Medical College of Wisconsin","Milwaukee","53226",[496,499],{"name":497,"role":73,"email":498},"Laura Roth, CCRC","lroth@mcw.edu",{"name":500,"role":78},"Nicholas Antos, MD",{"lat":502,"lon":503},43.0389,-87.90647,{"facility":505,"status":8,"city":506,"state":507,"zip":508,"country":509,"contacts":510,"geoPoint":516},"British Columbia Children's Hospital","Vancouver","British Columbia","V6H 3V4","Canada",[511,514],{"name":512,"role":73,"email":513},"Ronak S Ravandi","ronak.salamatravandi@bcchr.ca",{"name":515,"role":78},"Jonathan Rayment, MD",{"lat":517,"lon":518},49.24966,-123.11934,{"facility":520,"status":8,"city":521,"state":522,"zip":523,"country":509,"contacts":524,"geoPoint":530},"The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics","Toronto","Ontario","M5G 0A4",[525,528],{"name":526,"role":73,"email":527},"Claire Crompton","claire.crompton@sickkids.ca",{"name":529,"role":78},"Felix Ratjen, MD",{"lat":531,"lon":532},43.70643,-79.39864,[534],{"name":535,"role":73,"phone":536,"email":537},"Erika Enright","206-897-1922","eenright@uw.edu",[539,541],{"name":192,"affiliation":540,"role":78},"Indiana University",{"name":542,"affiliation":459,"role":78},"Margaret Rosenfeld, MD, MPH",[544],{"pmid":545,"type":546,"citation":547},"37683122","RESULT","Sanders DB, Bartz TM, Zemanick ET, Hoppe JE, Hinckley Stukovsky KD, Cogen JD, Bendy L, McNamara S, Enright E, Kime NA, Kronmal RA, Edwards TC, Morgan WJ, Rosenfeld M. A Pilot Randomized Clinical Trial of Pediatric Cystic Fibrosis Pulmonary Exacerbations Treatment Strategies. Ann Am Thorac Soc. 2023 Dec;20(12):1769-1776. doi: 10.1513\u002FAnnalsATS.202303-245OC.",[549],{"label":550,"url":551},"STOP PEDS Pilot Study manuscript","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F37683122\u002F",{"nct_id":4,"conditions":553,"biomarkers":554},[19],[555,556],"CFTR Gene","Cystic fibrosis sweat test",{"nct_id":4,"found":15,"summary":558,"prompt_version":568},{"design":559,"status":560,"heading":561,"summary":562,"follow_up":563,"word_count":564,"commitments":565,"compensation":566,"drugs_mentioned":567},"This is a multicenter, open-label, randomized controlled trial. It will compare two treatment strategies in 430 participants.","completed","Antibiotic Treatment Strategies for Pediatric Cystic Fibrosis Exacerbations","This study is looking at two different ways to treat lung flare-ups (pulmonary exacerbations) in children with cystic fibrosis (CF). One group will start preselected oral antibiotics right away for 14 days, along with increased airway clearance. The other group will also increase airway clearance, but will only start preselected oral antibiotics later if their symptoms get worse or don't improve. The study wants to see how these two approaches affect your child's lung function over one year, measured by a breathing test called ppFEV1. Children aged 3 to 18 with a confirmed CF diagnosis can join. The study is currently unclear on its recruitment status and aims to enroll 430 participants.","Participants will be followed for one year after treatment to measure changes in lung function.",112,"Participants will be followed for 12 months. They will increase airway clearance and may take oral antibiotics for 14 days.","Not stated in the trial record.",[],"v2"]