[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513904":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Alice Ho Miu Ling Nethersole Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention arm","ACTIVE_COMPARATOR","in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. We will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution The resulting locking solution will be instilled precisely to fill up the Tenckhoff catheter and the transfer set once a day. Prior to that, the existing PD solution is drained out first. As such, a \"dry abdomen\" is maintained during antibiotic-lock dwelling in the Tenckhoff catheter. This is to ensure the antibiotic-lock solution can be maintained within the catheter lumen for a prolonged period of time After a 6-hour dwell, the antibiotic-lock is drained out and usual PD schedule is resumed. Such a daily application of antibiotic lock shall last until the course of IP antibiotics is completed.",[13],"Drug: antibiotic lock",{"label":15,"type":6,"description":16,"interventionNames":17},"control arm","In the control arm, appropriate IP antibiotics are to be continued. The dosage and duration of antibiotics will fully follow the recommendation from the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines\n\n\\*For the subjects in the control arm who reach the defined primary end-point, they will automatically undergo crossover to the intervention arm to receive standard IP antibiotics together with the intra-catheter antibiotic-lock. They will be followed for another 6 months subsequently.",[18],"Drug: conventional IP antibiotics",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","antibiotic lock","In the intervention arm, in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. We will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution . Some commonly used antibiotics for the treatment of PD peritonitis with their suggested concentrations in the antibiotic-lock are quoted as below:\n\nCefazolin 10mg\u002FmL Ceftazidime 10mg\u002FmL Vancomycin 10mg\u002FmL Gentamicin 5mg\u002FmL Tienam 50mg\u002FmL",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"conventional IP antibiotics","In the control arm, appropriate IP antibiotics are to be continued. The dosage and duration of antibiotics will fully follow the recommendation from the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines",[15],[31],{"name":32,"affiliation":5,"role":33},"ping kwan chan","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Ping Kwan Chan","CONTACT","26892000","cpk618a@ha.org.hk",[41],{"facility":5,"status":42,"city":43,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Tai Po","Hong Kong","HK",{"type":47,"coordinates":48},"Point",[49,50],114.16877,22.45007,{"lat":50,"lon":49},[53],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},{"type":33,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"chan ping kwan","Associate Consultant, Department of Medicine","100513904","phase-4-clinical-trial-on-antibiotic-lock-in-tenckhoff-catheter-for-relasping-and-repeat-peritonitis-100513904",false,"NCT05971537","Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis","Inclusion Criteria:\n\n* PD patients who suffer from Either relapsing peritonitis (within 4 weeks of completion of antibiotics) or repeat peritonitis (between 4 to 12 weeks of completion of antibiotics), in which the causative organism is confirmed to be identical to the one in the preceding peritonitis episode, or Persistent growth of bacteria from PD effluent (PDE) after completion of standard 2-week antibiotic treatment, despite the resolution of symptoms and PDE leukocyte count \\\u003C100\u002Fmm3\n* Age \\> 18 years old\n* informed consent available\n\nExclusion Criteria:\n\n* Patients who do not respond to the appropriate IP antibiotics, evident by the persistence of peritonitis symptoms in which they should be referred for timely Tenchkoff catheter removal\n* Fungal or mycobacterial PD peritonitis\n* Co-existing exit site or tunnel tract infection\n* The presence of Tenckhoff catheter drainage dysfunction\n* \\\u003C= 3 years old\n* Pregnant patients",true,"ALL","18 Years",{"count":67,"type":68},46,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","Biofilm formation is an important cause of catheter-related infection. In hemodialysis, use of an antibiotic-lock has been proven to be effective to manage such a complication with preservation of the central venous catheter. In peritoneal dialysis, while biofilm has been implicated in relapsing and repeat peritonitis, both of which are caused by the identical bacteria as in their preceding peritonitis episode, no adjunctive measure has been proven to be effective to eradicate the biofilm bacteria. As a result, Tenckhoff catheter removal is the only recommended option for the patients suffering from relapsing or repeat peritonitis. In this study, the investigators are going to investigate whether the use of an antibiotic-lock can be useful to eradicate the biofilm in the Tenckhoff catheter to prevent future episodes of peritonitis caused by the same organism.",[74],"Peritoneal Dialysis-associated Peritonitis","2024-01-29",{"date":77,"type":78},"2024-01-31","ACTUAL",{"date":80,"type":78},"2023-06-15",{"date":82,"type":68},"2026-10",{"name":5,"class":6},1]