[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610626":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":36,"studyPopulation":24,"armGroups":37,"interventions":51,"overallOfficials":67,"centralContacts":71,"locations":24,"responsibleParty":77,"collaborators":79,"id":83,"slug":24,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":24,"enrollmentInfo":92,"targetDuration":24,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":103,"whyStopped":24,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":24},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Health-related quality of life.","Global physical health composite score of the 36-item Short-form General Health Survey (SF-36). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. Higher scores indicating better health and lower scores indicating worse health or disability","Week 4",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Safety of the study medication","ATL (U\u002FL), creat (μmol\u002FL) and adverse events","Week 4 and week 12",{"measure":19,"description":20,"timeFrame":17},"Tolerability of the study medication","Improvement on subscales of SF-36 questionnaire (Pain and physical function). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. higher scores indicating better health and lower scores indicating worse health or disability.",{"measure":22,"description":11,"timeFrame":23},"Health-related quality of life","Week 52",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":31},"QUADRUPLE",[32,33,34,35],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Rationale Assess other strategies for Lyme patients with vexing symptoms.\n\nObjective Provide initial insights as to whether addition of hydroxychloroquine results in reduction of physical complaints and assessing safety and tolerability of hydroxychloroquine in these patients.\n\nMain trial endpoints The primary endpoint is health-related quality of life, as measured by the global score of the 36-item Short-form General Health Survey (SF-36) at EOT (week 4).\n\nSecondary trial endpoints Secondary endpoints are improvement on subscales of SF-36 (pain and physical function) at week 4, safety at week 4 and 12 and global physical health composite score of the 36-item Short-form General Health Survey (SF-36) at week 52. Of note, there are no biochemical or microbiological test available to assess cure.\n\nTrial design This is a monocentre, randomized, double blind pilot study. Treatment last one month, with a follow up at week 52. In total the subject are participating for one year.\n\nTrial population Patients with possible persisting B. burgdorferi s.l. infection or probable or possible post Lyme treatment Lyme borreliosis syndrome (PTLBS) will be recruited. Patients who will start antibiotic treatment can be included.\n\nInterventions The intervention group will be treated with 28 days Doxycycline 2 x 100 mg (standard of care) combined with hydroxychloroquine 2 x 200 mg (two time a day one tablet). The control arm receives 28 days Doxycycline 2 x 100 mg (standard of care) combined with placebo 2 x 1 tablet.\n\nEthical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks The combination of doxycycline en hydroxychloroquine is based on expected synergy and probably enhancement of effective therapy. Its combination has been used for years in malaria and Q-fever. Its pro- and con's are well known.\n\nThe use of doxycycline and hydroxychloroquine is not associated with increased health risk.",[38,45],{"label":39,"type":40,"description":41,"interventionNames":42},"Doxycycline in combination with Hydroxychloroquine","EXPERIMENTAL","Doxycycline (standard of care) in combination with Hydroxychloroquine 2 x 200 mg (two times a day one tablet).",[43,44],"Drug: Hydroxychloroquin","Drug: Doxycycline",{"label":46,"type":47,"description":48,"interventionNames":49},"Doxycycline in combination with placebo","PLACEBO_COMPARATOR","Doxycycline (standard of care) in combination with Placebo (two times a day one tablet).",[50,44],"Drug: Placebo",[52,59,63],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","Hydroxychloroquin","Added to the standard of care for Lyme Disease",[39],[58],"Plaquenil",{"type":53,"name":60,"description":61,"armGroupLabels":62,"otherNames":24},"Placebo","Standard of care in combination with placebo",[46],{"type":53,"name":64,"description":65,"armGroupLabels":66,"otherNames":24},"Doxycycline","Standard of care",[39,46],[68],{"name":69,"affiliation":5,"role":70},"Hadewych Ter Hofstede, Dr.","PRINCIPAL_INVESTIGATOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":24,"email":76},"Hadewych ter Hofstede, Dr.","CONTACT","+3124361819","hadewych.terhofstede@radboudumc.nl",{"type":78,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[80],{"name":81,"class":82},"Ministerie van Volksgezondheid, Welzijn en Sport","UNKNOWN","100610626",false,"NCT07230028","Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.","A Monocenter, Randomized, Double Blind Pilot Study Comparing Doxycycline in Combination With Hydroxychloroquine Treatment Versus Doxycycline Monotherapy in Patients With Long-Term Complaints Attributed to Lyme Borreliosis.","DoBo","Inclusion Criteria:\n\n* Patients who are 18 years of age or older\n* Patients with probable or possible signs and symptoms attributed to Lyme borreliosis\n* Patients with probable or possible post Lyme treatment Lyme borreliosis syndrome (PTLBS)\n* Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).\n\nExclusion Criteria:\n\n* Known contra-indication for used study medication.\n* Women who are pregnant or lactating","ALL","18 Years",{"count":93,"type":94},50,"ESTIMATED","INTERVENTIONAL",[97],"PHASE4","The goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults. The main questions it aims to answer are:\n\nDoes addition of hydroxychloroquine reduce physical complaints? Researchers will compare hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if hydroxychloroquine works to treat Lyme borreliosis.\n\nParticipants will:\n\nTake hydroxychloroquine or a placebo two times a day during 28 days. Visit the clinic 4 times in one year for checkups and tests.",[100],"Lyme Borreliosis, Nervous System",[102],"Hydroxychloroquine","NOT_YET_RECRUITING","2025-11-14",{"date":106,"type":107},"2025-11-17","ACTUAL",{"date":109,"type":94},"2026-03-01",{"date":111,"type":94},"2027-11-01",{"name":5,"class":6}]