Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT06929767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease (COPD) Need Antibiotics and Steroids?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding: The assessing physician is not blinded to group allocation, but if randomized to standard of care, the physician does not access the biomarkers (or in other words the physician writes the Rx blinded to the CRP and blood eosinophil values). The patient is blinded to group allocation and their own biomarker values but not to the specific treatment. In order to ensure the patient cannot see their own bio-markers, these results will not be released to be shared with patients in the electronic medical record. The research assistant (also the outcome assessor) will be blinded to group allocation, and biomarker values, but not to specific treatment.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We are studying the use of bio-markers to aide in decision-making for the prescription of pharmacotherapy in acute exacerbations of COPD (AECOPD). The intervention arm is using bio-markers to decide whether a patient should received antibiotics and/or steroids for their AECOPD. The control arm is using standard advice from GOLD (the Global Initiative for Obstructive Lung Disease) recommendations for prescription of therapy in AECOPD.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to determine the number of patients screened, enrolled, and randomized within a 12-month period.', 'timeFrame': '12 months', 'description': 'We need to know if this is a study that patients would want to do, and if this is a study that physicians would be willing to enroll or refer patients to.\n\n* number screened: an absolute count of patients who are contacted by the RA for initial screening and information\n* proportion enrolled: number of subjects who verbally consent divided by number of subjects screened\n* proportion randomized: number of subjects who had an exacerbation and were randomized divided by number of subjects enrolled'}], 'secondaryOutcomes': [{'measure': 'To determine what proportion of patients had exacerbations after enrollment but prior to randomization, that were missed by the study.', 'timeFrame': '12 months', 'description': 'This outcome is needed to evaluate if our method of capturing exacerbations is effective.\n\n-The number of times a patient was prescribed antibiotics and/or steroids between enrollment and randomization divided by number of patients enrolled.'}, {'measure': 'To determine what proportion of physicians were adherent to the treatment recommendations provided.', 'timeFrame': '12 months', 'description': 'To determine if physicians are willing to consider using this protocol in a study, to approximate the amount of cross-over we might get if the larger trial is not a phase 3 study\n\n-The number of prescriptions adherent to biomarker recommendations divided by the number of subjects randomized to the intervention arm'}, {'measure': 'To determine what percentage of patients would fall into each category: What percentage had blood eosinophils > = 2% ? What percentage had CRP > = 40? What percentage had CRP < 20? What percentage had purulent sputum ?', 'timeFrame': '12 months', 'description': 'To determine if we would get enough patients in all categories for a larger trial to be feasible.\n\n* the number of randomized subjects with blood eosinophils \\> =2% divided by the total number of randomized subjects\n* the number of randomized subjects with CRP \\> = 40 divided by total number of randomized subjects\n* the number of randomized subjects with CRP \\< 20 divided by the total number of randomized subjects\n* the number of randomized subjects with purulent sputum divided by the total number of randomized subjects'}, {'measure': 'To determine what percentage of patients had taken a photograph of their sputum or brought sputum to be assessed in-person.', 'timeFrame': '12 months', 'description': 'To determine if we would be able to reliably assess sputum purulence using this methodology in a larger trial\n\n-number of randomized subjects with photographs of sputum or sputum brought in container to in-person appointment divided by the total number of randomized subjects'}, {'measure': 'To determine how many patients had complete data collection.', 'timeFrame': '12 months', 'description': 'To determine if this protocol will provide a robust data set.\n\n* number of subjects with complete data set divided by number randomized.\n* complete data set includes:\n* visit 0 - CXR, blood eosinophils, CRP, CAT score\n* visit 1 - CAT score, medication adherence, questions answered re additional health care utilization\n* visit 2 - CAT score, medication adherence, questions answered re additional health care utilization\n* visit 3 - CAT score, questions answered re additional health care utilization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bio-maker', 'C reactive protein', 'CRP', 'eosinophils', 'exacerbation', 'COPD exacerbation', 'AECOPD', 'biomarker'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'COPD', 'Exacerbation of COPD', 'AECOPD', 'ECOPD']}, 'referencesModule': {'references': [{'pmid': '37924830', 'type': 'BACKGROUND', 'citation': "Ramakrishnan S, Jeffers H, Langford-Wiley B, Davies J, Thulborn SJ, Mahdi M, A'Court C, Binnian I, Bright S, Cartwright S, Glover V, Law A, Fox R, Jones A, Davies C, Copping D, Russell RE, Bafadhel M. Blood eosinophil-guided oral prednisolone for COPD exacerbations in primary care in the UK (STARR2): a non-inferiority, multicentre, double-blind, placebo-controlled, randomised controlled trial. Lancet Respir Med. 2024 Jan;12(1):67-77. doi: 10.1016/S2213-2600(23)00298-9. Epub 2023 Nov 2."}, {'pmid': '22447964', 'type': 'BACKGROUND', 'citation': 'Bafadhel M, McKenna S, Terry S, Mistry V, Pancholi M, Venge P, Lomas DA, Barer MR, Johnston SL, Pavord ID, Brightling CE. Blood eosinophils to direct corticosteroid treatment of exacerbations of chronic obstructive pulmonary disease: a randomized placebo-controlled trial. Am J Respir Crit Care Med. 2012 Jul 1;186(1):48-55. doi: 10.1164/rccm.201108-1553OC. Epub 2012 Mar 23.'}, {'pmid': '35242374', 'type': 'BACKGROUND', 'citation': 'Zhang K, Xie K, Zhang C, Liang Y, Chen Z, Wang H. C-reactive protein testing to reduce antibiotic prescribing for acute respiratory infections in adults: a systematic review and meta-analysis. J Thorac Dis. 2022 Jan;14(1):123-134. doi: 10.21037/jtd-21-705.'}, {'pmid': '35549921', 'type': 'BACKGROUND', 'citation': 'Hoult G, Gillespie D, Wilkinson TMA, Thomas M, Francis NA. Biomarkers to guide the use of antibiotics for acute exacerbations of COPD (AECOPD): a systematic review and meta-analysis. BMC Pulm Med. 2022 May 13;22(1):194. doi: 10.1186/s12890-022-01958-4.'}, {'type': 'BACKGROUND', 'citation': 'C REACTIVE PROTEIN-GUIDED ANTIBIOTIC PRESCRIBING VS STANDARD OF CARE IN EXACERBATIONS OF COPD: A SYSTEMATIC REVIEW WITH META-ANALYSIS Luks, Vanessa et al. CHEST, Volume 158, Issue 4, A1788'}, {'pmid': '19681947', 'type': 'BACKGROUND', 'citation': 'Daniels JM, de Graaff CS, Vlaspolder F, Snijders D, Jansen HM, Boersma WG. Sputum colour reported by patients is not a reliable marker of the presence of bacteria in acute exacerbations of chronic obstructive pulmonary disease. Clin Microbiol Infect. 2010 Jun;16(6):583-8. doi: 10.1111/j.1469-0691.2009.02892.x. Epub 2009 Jul 20.'}, {'pmid': '19027281', 'type': 'BACKGROUND', 'citation': 'Brusse-Keizer MG, Grotenhuis AJ, Kerstjens HA, Telgen MC, van der Palen J, Hendrix MG, van der Valk PD. Relation of sputum colour to bacterial load in acute exacerbations of COPD. Respir Med. 2009 Apr;103(4):601-6. doi: 10.1016/j.rmed.2008.10.012. Epub 2008 Nov 22.'}, {'pmid': '10858396', 'type': 'BACKGROUND', 'citation': "Stockley RA, O'Brien C, Pye A, Hill SL. Relationship of sputum color to nature and outpatient management of acute exacerbations of COPD. Chest. 2000 Jun;117(6):1638-45. doi: 10.1378/chest.117.6.1638."}, {'pmid': '22523352', 'type': 'BACKGROUND', 'citation': 'Soler N, Esperatti M, Ewig S, Huerta A, Agusti C, Torres A. Sputum purulence-guided antibiotic use in hospitalised patients with exacerbations of COPD. Eur Respir J. 2012 Dec;40(6):1344-53. doi: 10.1183/09031936.00150211. Epub 2012 Apr 20.'}, {'pmid': '32676981', 'type': 'BACKGROUND', 'citation': 'Chen K, Pleasants KA, Pleasants RA, Beiko T, Washburn RG, Yu Z, Zhai S, Drummond MB. Procalcitonin for Antibiotic Prescription in Chronic Obstructive Pulmonary Disease Exacerbations: Systematic Review, Meta-Analysis, and Clinical Perspective. Pulm Ther. 2020 Dec;6(2):201-214. doi: 10.1007/s41030-020-00123-8. Epub 2020 Jul 16.'}, {'pmid': '31393400', 'type': 'BACKGROUND', 'citation': 'Li Z, Yuan X, Yu L, Wang B, Gao F, Ma J. Procalcitonin-guided antibiotic therapy in acute exacerbation of chronic obstructive pulmonary disease: An updated meta-analysis. Medicine (Baltimore). 2019 Aug;98(32):e16775. doi: 10.1097/MD.0000000000016775.'}, {'type': 'BACKGROUND', 'citation': 'Council of the Canadian Academies, 2019. When Antibiotics Fail. Ottawa (ON). The Expert Panel on the Potential Socio-Economic Impacts of Antimicrobial Resistance in Canada, Council of Canadian Academies.'}, {'pmid': '28404617', 'type': 'BACKGROUND', 'citation': 'Waljee AK, Rogers MA, Lin P, Singal AG, Stein JD, Marks RM, Ayanian JZ, Nallamothu BK. Short term use of oral corticosteroids and related harms among adults in the United States: population based cohort study. BMJ. 2017 Apr 12;357:j1415. doi: 10.1136/bmj.j1415.'}, {'pmid': '24925917', 'type': 'BACKGROUND', 'citation': 'Bafadhel M, Davies L, Calverley PM, Aaron SD, Brightling CE, Pavord ID. Blood eosinophil guided prednisolone therapy for exacerbations of COPD: a further analysis. Eur Respir J. 2014 Sep;44(3):789-91. doi: 10.1183/09031936.00062614. Epub 2014 Jun 12. No abstract available.'}, {'pmid': '28298398', 'type': 'BACKGROUND', 'citation': 'Wedzicha JA Ers Co-Chair, Miravitlles M, Hurst JR, Calverley PM, Albert RK, Anzueto A, Criner GJ, Papi A, Rabe KF, Rigau D, Sliwinski P, Tonia T, Vestbo J, Wilson KC, Krishnan JA Ats Co-Chair. Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017 Mar 15;49(3):1600791. doi: 10.1183/13993003.00791-2016. Print 2017 Mar.'}, {'pmid': '30371937', 'type': 'BACKGROUND', 'citation': 'Vollenweider DJ, Frei A, Steurer-Stey CA, Garcia-Aymerich J, Puhan MA. Antibiotics for exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2018 Oct 29;10(10):CD010257. doi: 10.1002/14651858.CD010257.pub2.'}, {'pmid': '12181400', 'type': 'BACKGROUND', 'citation': 'Sethi S, Evans N, Grant BJ, Murphy TF. New strains of bacteria and exacerbations of chronic obstructive pulmonary disease. N Engl J Med. 2002 Aug 15;347(7):465-71. doi: 10.1056/NEJMoa012561.'}, {'type': 'BACKGROUND', 'citation': 'Chen Y. Interpretation of Global Strategy for the Diagnosis, Treatment, Management and Prevention of Chronic Obstructive Pulmonary Disease 2022 Report. Vol. 25, Chinese General Practice. 2022.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to see if the use of two simple blood tests: C reactive protein and eosinophils, can reduce the use of steroids and antibiotics in patients with flares of chronic obstructive pulmonary disease (COPD) without reducing the chance of treatment success. Before we undertake a large trial to answer these questions, we need to do a small feasibility study to see if our study design will work. The questions we need to answer include:\n\nHow many participants will we able to include in the study over 12 months?\n\nHow many participants in the trial will take all of their medications?\n\nWill study protocols be followed?\n\nHow much information will we be missing at the end of the study?\n\nHow many study participants will take photographs of the phlegm they are coughing up or bring in a sample of the phlegm for inspection by study doctor?\n\nParticipants will:\n\nCome into the clinic to be assessed when they have a flare of COPD, get a chest x-ray, blood work, and a doctor visit. The doctor will provide a prescription if it is a flare of COPD.\n\nThe participant will get a call 3, 14, and 30 days later by a study researcher to ask questions about if the medications have been taken, if cough or shortness of breath remain, and if they have had to seek additional care from another doctor, clinic, or emergency room.', 'detailedDescription': "Study design: randomized, controlled, feasibility trial\n\nPopulation: Adult patients with a physician diagnosis of COPD suffering from an acute exacerbation of COPD\n\nIntervention: Recommendations for antibiotics and/or glucocorticoids based on CRP, peripheral blood eosinophils +/- sputum colour provided to treating physician.\n\nComparator: Recommendations for antibiotics and/or glucocorticoids based on current standard of care recommendations in the GOLD guidelines provided to treating physician.\n\nRecruitment/Setting: Patients with COPD will be approached in the outpatient respiratory clinic at The Ottawa Hospital during a visit to see their treating respirologist. The nurse will identify COPD patients to the treating respirologist at the beginning of the visit using coloured flags in Epic. The respirologist will ask the patient if they would like to participate in this study. If they are interested, the patient will be referred to the clinical research assistant. Alternatively, the patient can self-refer by emailing or phoning the research number on the poster. The research assistant will follow-up with the patient via telephone to discuss preferred methods of communication to discuss the trial, updates, and do the informed consent. If applicable, the research assistant will have the patient fill out a consent to communicate via email form. If the research assistant cannot reach the patient via telephone, and they initially received an email, the research assistant may respond to the email with the request that the patient sign the consent to communicate via email before any additional information is provided to the patient.\n\nNumber of Centres Participating in the feasibility study: The Ottawa Hospital only for the feasibility study.\n\nConsent: A meeting to have the consent discussion will be coordinated by the research assistant (RA) when they first call the patient or when the patient self-refers in response to the poster. The RA will set up a video conference via MS Teams, if this is not feasible for the patient, a telephone discussion will be done. The patient will receive a copy of the consent form in advance of the meeting via either MyChart Epic, email via MS 365 Share point (download link, encrypted file), fax to their fax machine or mail (whatever they prefer). Patients will be advised that although they have verbally agreed to the trial, written consent will be obtained, and they will be asked to sign the physical consent form at the time of the in-person study visit 1.\n\nStudy Procedures\n\nAfter consent, the research coordinator will provide standard education to all patients on the symptoms of AECOPD, provide them with a checklist of symptoms of AECOPD, and a phone number to call should they meet criteria for AECOPD. This phone number will be operational 8am to 11am Monday to Friday to provide a same-day in-person visit with a study respirologist (that afternoon). The patients will also be contacted via telephone or email (depending on patient preference), on the first Monday of every month to remind them of the study number to call in the event of any exacerbation. The method of communication (email or phone call) will be determined by the RA at the consent meeting. The RA will also check Epic the first Monday of each month to see if the patient was prescribed any antibiotics or prednisone outside of the trial (suggesting patient exacerbations are being missed for randomization).\n\nIf the patient experiences an AECOPD:\n\nThe patient will call the number, and the research assistant will meet the patient at the study site (at a pre-arranged location). The patient will sign the consent form. A chest x-ray and blood work (CRP, CBC with differential) will be done immediately prior to seeing the study respirologist. The study respirologist will confirm that the patient is suffering from an AECOPD (by history and physical exam) and will confirm eligibility for randomization (including ruling out fever and reviewing the chest x-ray to rule out presence of pneumonia). At this point the patient will be randomized into the study. Baseline demographics will be collected at this time including age, smoking history, last FEV1, number of exacerbations in the last year, current chronic COPD medications, use of oxygen, any positive sputum cultures within the last year. The patients will also fill out a COPD Assessment Test (CAT) score (for comparison to future values). The CAT test takes \\< 3 minutes to fill out.\n\nThe randomization process will consist of a computer-generated random listing of the two different treatment allocations blocked by variable blocks of two or four. Randomization will be through central allocation of a randomization schedule and will be coordinated by the Ottawa Health Research Institute.\n\nAfter randomization, the treating physician will create a treatment prescription in Epic:\n\n* If randomized to the intervention arm (biomarker-guided therapy), the physician will be provided with the biomarker-guided recommendations and will access Epic to look at the patient's biomarkers. The physician will then write a Rx for the patient keeping these recommendations in mind (but not being bound by them). Patient allergies will be taken into account when writing the Rx.\n* If randomized to the control arm (standard of care) arm, the physician will write a prescription based on what they feel is standard of care (and will not look at the biomarker results). Patient allergies will be taken into account when writing the Rx.\n\nBlinding: The assessing physician is not blinded to group allocation, but if randomized to standard of care, the physician does not access the biomarkers (or in other words the physician writes the Rx blinded to the CRP and blood eosinophil values). The patient is blinded to group allocation and their own biomarker values but not to the specific treatment. In order to ensure the patient cannot see their own bio-markers, these results will not be released to be shared with patients in the electronic medical record. The research assistant (also the outcome assessor) will be blinded to group allocation, and biomarker values, but not to specific treatment.\n\nAssessments: Patients will be assessed at day 3, 14, and day 30 post-randomization by telephone by the clinical research assistant who is blinded to group allocation and biomarker values. At each call, requirement for additional visits for respiratory symptoms, completion of study medications, intensification or change of therapy, and the CAT will be administered. At day 3, if the patient feels worse, they will be advised to seek medical attention with their treating respirologist. The research assistant will also contact the treating respirologist to advise them of the worsening of a Bidex patient. At day 14, if the patient feels they have not improved, the research assistant will advise the patient to seek medical attention by calling their treating respirologist. The research assistant will also contact the treating respirologist to advise them of the lack of improvement of a patient enrolled in Bidex. At day 30, if the patient feels they have not improved, the research assistant will advise the patient to seek medical attention by calling their treating respirologist. The research assistant will also contact the treating respirologist to advise them of the lack of improvement of a patient enrolled in Bidex."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients with a known diagnosis of COPD (must have prior spirometry documenting FEV1/FVC post-bronchodilator \\< 0.7 or documented respirologist-diagnosis of COPD)\n* Presenting with AECOPD, defined as an increase in respiratory symptoms necessitating an increase in medications\n* Consent provided\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n* new infiltrate on chest x-ray day of randomization\n* temperature ≥ 38.0 ◦C taken orally day of randomization\n* positive blood culture day of randomization\n* co-morbid asthma or severe bronchiectasis\n* acute heart failure day of randomization\n* known immunosuppression including the use of chronic glucocorticoids day of randomization\n* allergy/absolute contraindication to the use of oral steroids\n* planned pregnancy or currently pregnant\n* COVID positive'}, 'identificationModule': {'nctId': 'NCT06929767', 'acronym': 'Bidex', 'briefTitle': 'Do Blood Tests Help to Decide Which Patients With Flares of Chronic Obstructive Pulmonary Disease (COPD) Need Antibiotics and Steroids?', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Biomarker Guided Decision-making in Acute Exacerbation of COPD: a Feasibility Study', 'orgStudyIdInfo': {'id': '20240689-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention Arm', 'description': "If randomized to the intervention arm (biomarker-guided therapy), the physician will be provided with the biomarker-guided recommendations and will access Epic to look at the patient's biomarkers. The physician will then write a Rx for the patient keeping these recommendations in mind (but not being bound by them). Patient allergies will be taken into account when writing the Rx.\n\n* if blood eosinophils are \\>=2%, steroids are recommended\n* if blood eosinophils are \\< 2%, steroids are not recommended (unless the patient also has CRP \\< 20 with non-purulent sputum, then an abbreviated course of steroids can be considered)\n* if CRP is \\>= 40 mg/L,or \\>=20 with purulent sputum, antibiotics are recommended; if neither condition is met, antibiotics are not recommended.", 'interventionNames': ['Other: biomarker-guided decision making']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care arm', 'description': 'If randomized to the control arm (standard of care) arm, the physician will write a prescription based on what they feel is standard of care (and will not look at the biomarker results). Patient allergies will be taken into account when writing the Rx.\n\n* standard of care recommendations based on most recent GOLD publication will be provided which currently include:\n* steroids in all patients with AECOPD\n* antibiotics only if there are 2 out of 3 cardinal symptoms (dyspnea, cough, sputum), and one of the symptoms has to be purulent sputum', 'interventionNames': ['Other: GOLD recommendations']}], 'interventions': [{'name': 'biomarker-guided decision making', 'type': 'OTHER', 'description': '-recommendations for antibiotic and steroid Rx provided to study physician based on bio-marker (serum CRP, blood eosinophils, sputum colour) results.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'GOLD recommendations', 'type': 'OTHER', 'description': 'Recommendations provided to study physician for Rx of antibiotics and steroids based on current GOLD recommendations', 'armGroupLabels': ['Standard of care arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Vanessa PJ Luks, MD', 'role': 'CONTACT', 'email': 'vluks@toh.ca', 'phone': '613-737-8198'}], 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Vanessa PJ Luks, MD', 'role': 'CONTACT', 'email': 'vluks@toh.ca', 'phone': '613-737-8198'}], 'overallOfficials': [{'name': 'Vanessa PJ Luks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHRI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}