[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552753":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":75,"collaborators":77,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":26,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Makerere University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention: Doxycycline","EXPERIMENTAL","Oral doxycycline (100 mg) administered once daily for 12 weeks",[13],"Drug: Doxycycline",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","PLACEBO_COMPARATOR","Oral placebo (matching with doxycycline) will be administered once daily for 12 weeks",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Doxycycline","Doxycycline is a bacteriostatic tetracycline antibiotic with ability to immunomodulate matrix metalloproteinases, enzymes well known to cause lung damage via breakdown lung extracellular matrix.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","This will be a chemically inert substance, designed to match oral doxycycline capsules but with no chemically active ingredients.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ahmed Ddungu, MBCHB,MMED","CONTACT","0782303377","ahddungu@yahoo.com",[38,66],{"facility":39,"status":40,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Makerere University Lung Institute","NOT_YET_RECRUITING","Kampala","00256","Uganda","UG",{"type":46,"coordinates":47},"Point",[48,49],32.58219,0.31628,{"lat":49,"lon":48},[52,54,58,60,62,64],{"name":33,"role":34,"phone":53,"phoneExt":26,"email":36},"+256782303377",{"name":55,"role":34,"phone":56,"phoneExt":26,"email":57},"Bruce Kirenga, MBCHB,PHD","256782404431","brucekirenga@yahoo.co.uk",{"name":33,"role":59,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":55,"role":61,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":63,"role":61,"phone":26,"phoneExt":26,"email":26},"Harriet Mayanja, MBCHB,PHD",{"name":65,"role":61,"phone":26,"phoneExt":26,"email":26},"Lucian Davis, MD",{"facility":67,"status":68,"city":41,"state":26,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Mulago National Referral Hospital","RECRUITING",{"type":46,"coordinates":70},[48,49],{"lat":49,"lon":48},[73],{"name":74,"role":34,"phone":53,"phoneExt":26,"email":36},"Ahmed Ddungu, MBCHB, M.MED-Internal Medicine",{"type":76,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[78],{"name":39,"class":79},"UNKNOWN","100552753","phase-2-characterization-of-tuberculosis-associated-lung-fibrosis-and-respiratory-impairment-and-prevention-using-doxycycline-100552753",false,"NCT06477185","Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline","Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline in A Double Blind Randomized Controlled Trial","TALF-TB","Inclusion Criteria:\n\n* Age of 18 - 65 years\n* Index PTB episode (sputum smear positive or GeneXpert positive with rifampicin susceptibility)\n* Baseline CXR showing infiltrates in at least 2 lung zones (≥30% lung involvement) meeting criteria for moderate\u002Fadvanced PTB\n* HIV uninfected\n* Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Able to give written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Baseline serum creatinine or liver enzymes \\>2 times above upper limit of normal\n* Taking corticosteroids for ≥14 days or anti-TBs \\>7days\n* Prospects already enrolled in another clinical trial\n* Diabetic patients (most diabetics are on metformin or have history of metformin use. Metformin is postulated to have an anti-fibrosis role)\n* Patients with malignancy or on anticancer medication\n* Situation where a participant is taking a drug\u002Fmedication known to interact with the trial drug.\n* Known allergies to doxycycline or other tetracyclines\n* Known autoimmune disease\n* Any factor felt to significantly increase risk of adverse event","ALL","18 Years","65 Years",{"count":92,"type":93},200,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","The goal of this clinical trial is to assess the efficacy(effectiveness) of doxycycline, a potent inhibitor of matrix metalloproteinase (lung collagenase) activity in prevention of Tuberculosis associated lung fibrosis and associated lung function decline among patients with drug sensitive advanced TB. The main question\\[s\\] it aims to answer are:\n\n* Does doxycycline have a significant anti-fibrosis role when given as adjuvant therapy to TB patients with advanced pulmonary TB in a double blind randomized placebo controlled trial?\n* How does long term respiratory function defer between patients who received adjuvant doxycycline aimed at prevention of TB associated lung fibrosis and those who received a placebo in a double blind randomized controlled trial?\n\nParticipants will be subjected to the following:\n\n* Experimental arm: Doxycycline 100 mg once daily for 12 weeks administered concurrently with standard of care anti-TBs.\n* Comparator arm: Placebo once daily for 12 weeks administered concurrently with standard of care anti-TBs.",[99],"Tuberculosis, Pulmonary","2025-04-14",{"date":102,"type":103},"2025-04-17","ACTUAL",{"date":105,"type":103},"2024-12-04",{"date":107,"type":93},"2027-12",{"name":5,"class":6},2]