Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-02-23 @ 1:44 AM
Study NCT ID:
NCT05750966
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2023-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002761', 'term': 'Cholangitis'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005839', 'term': 'Gentamicins'}, {'id': 'D002444', 'term': 'Cefuroxime'}, {'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients and investigators will know in which group they are assigned.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is designed as an open-label multicenter non-inferiority RCT. Patients will be randomly assigned to the intervention group (one day of ABT after ERCP) or the comparator group (4 to 7 days of ABT after ERCP).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical cure rate by day 14 after ERCP without relapse by day 30', 'timeFrame': '30 days', 'description': 'Clinical cure is defined as the absence of both fever (\\>38°C) and/or shaking chills, and initial presenting symptoms. Relapse is defined as the initiation of new antibiotic therapy for recurrent cholangitis, subsequent infection in the hepatic-pancreatic-biliary region, or any other subsequent infection possibly related to the initial episode of cholangitis.'}], 'secondaryOutcomes': [{'measure': 'All-cause 90-day mortality.', 'timeFrame': '90 days', 'description': 'Mortality, which includes all causes.'}, {'measure': 'Relapse of cholangitis within 90 days', 'timeFrame': '90 days', 'description': 'Relapse is defined as the initiation of new antibiotic therapy for recurrent cholangitis, subsequent infection in the hepatic-pancreatic-biliary region, or any other subsequent infection possibly related to the initial episode of cholangitis.'}, {'measure': 'Rate of any other subsequent infection requiring antibiotic therapy within 90 days.', 'timeFrame': '90 days', 'description': 'Subsequent infections excluding recurrent cholangitis.'}, {'measure': 'Rate of subsequent infections with MDR bacteria or Clostridioides difficile within 90 days.', 'timeFrame': '90 days', 'description': 'Subsequent infections, in particular due to resistant bacteria.'}, {'measure': 'Rate of other adverse drug events within 14 days', 'timeFrame': '14 days', 'description': 'Includes: rash, diarrhoea (defined as ≥3 x loose stools per day), liver function abnormalities (defined as ≥5 x upper limit of normal (ULN) elevation in alanine aminotransferase (ALT) or ≥2 x ULN elevation in alkaline phosphatase (ALP) or ≥3 x ULN elevation in ALT and simultaneous elevation of total bilirubin concentration exceeding 2 x ULN (according to European association for the Study of the Liver Clinical Practice Guidelines: Drug-induced liver injury) AND without evidence of persistent obstruction on imaging OR elevation of liver enzymes after initial decrease. Lastly, other adverse drug events includes acute kidney injury, defined as increase in serum creatinine by ≥26.5 micromol/L within 48 hours or increase in serum creatinine to ≥1.5 times baseline (according to Kidney Disease: Improving Global Outcomes guidelines).'}, {'measure': 'Length of intensive care and hospital stay for the initial episode of cholangitis.', 'timeFrame': '30 days', 'description': 'Length of IC and hospital stay defined in days.'}, {'measure': 'Quality of life and health utility.', 'timeFrame': '90 days', 'description': 'This will be evaluated using the RAND-36 and EQ-5D-5L at day 7, day 30 and day 90.\n\nScale title (RAND-36): Research and Devevelopment-36 Minimum raw score: 45 Maximum raw score : 198 Higher scores mean a better outcome.\n\nScale title (EQ-5D-5L): European Quality of Life-5 Dimensions-5 Levels score Minimum score: 11111 Maximum score: 55555 Higher scores mean a worse outcome.'}, {'measure': 'Societal costs and cost-effectiveness/-utility', 'timeFrame': '90 days', 'description': 'The costs per cured patient without relapse and the costs per quality adjusted life year (QALY) Scale Title: Quality Adjusted Life Year. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health.QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale).\n\nMinimum score: 0 Maximum score: 1 Higher scores mean a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiotics', 'randomized controlled trial'], 'conditions': ['Cholangitis']}, 'referencesModule': {'references': [{'pmid': '28941329', 'type': 'BACKGROUND', 'citation': 'Miura F, Okamoto K, Takada T, Strasberg SM, Asbun HJ, Pitt HA, Gomi H, Solomkin JS, Schlossberg D, Han HS, Kim MH, Hwang TL, Chen MF, Huang WS, Kiriyama S, Itoi T, Garden OJ, Liau KH, Horiguchi A, Liu KH, Su CH, Gouma DJ, Belli G, Dervenis C, Jagannath P, Chan ACW, Lau WY, Endo I, Suzuki K, Yoon YS, de Santibanes E, Gimenez ME, Jonas E, Singh H, Honda G, Asai K, Mori Y, Wada K, Higuchi R, Watanabe M, Rikiyama T, Sata N, Kano N, Umezawa A, Mukai S, Tokumura H, Hata J, Kozaka K, Iwashita Y, Hibi T, Yokoe M, Kimura T, Kitano S, Inomata M, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: initial management of acute biliary infection and flowchart for acute cholangitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):31-40. doi: 10.1002/jhbp.509. Epub 2018 Jan 8.'}, {'pmid': '35953772', 'type': 'BACKGROUND', 'citation': 'Sieswerda E, Bax HI, Hoogerwerf JJ, de Boer MGJ, Boermeester M, Bonten MJM, Dekker D, van Wijk RG, Juffermans NP, Kuindersma M, van der Linden PD, Melles DC, Pickkers P, Schouten JA, Rebel JR, van Zanten ARH, Prins JM, Wiersinga WJ. The 2021 Dutch Working Party on Antibiotic Policy (SWAB) guidelines for empirical antibacterial therapy of sepsis in adults. BMC Infect Dis. 2022 Aug 11;22(1):687. doi: 10.1186/s12879-022-07653-3.'}, {'pmid': '33462749', 'type': 'BACKGROUND', 'citation': 'Haal S, Wielenga MCB, Fockens P, Leseman CA, Ponsioen CY, van Soest EJ, van Wanrooij RLJ, Sieswerda E, Voermans RP. Antibiotic Therapy of 3 Days May Be Sufficient After Biliary Drainage for Acute Cholangitis: A Systematic Review. Dig Dis Sci. 2021 Dec;66(12):4128-4139. doi: 10.1007/s10620-020-06820-3. Epub 2021 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this multicentre randomized controlled trial is to investigate if a very short-course of antibiotics (1 day) for cholangitis after adequate drainage is non-inferior with respect to clinical cure in comparison with a standard course of antibiotics (4 to 7 days). Secondary objectives include:\n\n* Will a one-day course of antibiotics for cholangitis after adequate drainage be non-inferior with respect to relapse of cholangitis and mortality in comparison with a standard course of antibiotics?\n* Will a one-day course of antibiotics for cholangitis after adequate drainage result in less adverse drug events in comparison with a standard course of antibiotics?\n* Will a one-day course of antibiotics for cholangitis after adequate drainage reduce length of hospital stay?\n* Will a one-day course of antibiotics for cholangitis after adequate drainage improve quality of life?\n* Will a one-day course of antibiotics for cholangitis after adequate drainage be cost-effective?', 'detailedDescription': 'Acute cholangitis is an infection of the biliary tract which is managed with biliary drainage and antibiotic therapy (ABT). Currently the international Tokyo Guidelines 2018 (TG18) recommend 4 to 7 days of ABT after source control. The national SWAB guideline of 2020 suggests a course of one to 3 days after biliary drainage. There are no randomized studies to guide the duration of ABT for acute cholangitis. Our recent retrospective study in the Netherlands showed that a short course of ABT seems safe and more evidence is available showing that other bacterial infections, including abdominal and bloodstream infections, can be treated with a short antibiotic course than previously assumed. Hence, the hypothesis is that a very short-course of ABT for acute cholangitis is non-inferior to a course of 4 to 7 days after adequate biliary drainage.\n\nThis study is designed as a multicenter non-inferiority randomized controlled trial. Patients will be randomly assigned to the intervention group (one day of antibiotic therapy after ERCP) or the comparator group (4 to 7 days of antibiotic therapy after ERCP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with acute cholangitis due to common bile duct stones, benign or malignant distal biliary obstruction or distal biliary stent dysfunction (only stents in situ for a minimum of 30 days)\n* ERCP with adequate biliary drainage (all common bile duct stones are removed and/or there is adequate flow of clear bile with or without a biliary stent(s))\n* Absence of fever (temperature \\<38.5°C) or a decrease of body temperature of at least 1°C has occurred within 24 hours after ERCP\n* Age ≥ 18 years\n* Written informed consent (IC)\n\nExclusion Criteria:\n\n* Other aetiologies of acute cholangitis (e.g. primary sclerosing cholangitis, (sub)hilar and/or intrahepatic strictures or hilar stents)\n* A recurrent cholangitis (within 3 months)\n* Patients with surgically altered anatomy (leading to biliary-enteric anastomosis)\n* Concomitant pancreatitis, according to International Association of Pancreatology/American Pancreatic Association guidelines.\\[18\\] Acute pancreatitis is diagnosed in case of fulfilment of 2 out of 3 of the following criteria:\n\n * Upper abdominal pain\n * Serum amylase or lipase \\>3x ULN\n * Signs of acute pancreatitis on imaging\n* Concomitant cholecystitis, according to TG18 criteria.\\[19\\] Acute cholecystitis is suspected in case one item in A is met and one item in B and C.\n\nA. Local signs of inflammation\n\n* A1: Murphy's sign\n* A2: Right upper quadrant mass/pain/tenderness B. Systemic signs of inflammation\n* B1: Fever\n* B2: Elevated C-reactive protein\n* B3: Elevated WBC count C. Imaging findings characteristic of acute cholecystitis\n\n * Concomitant liver abscess\n * Another additional infectious diagnosis\n * Admission on an Intensive Care Unit (ICU) at time of randomisation\n * Use of maintenance antimicrobial therapy\n * Use of immunosuppressants\n * Neutropenia"}, 'identificationModule': {'nctId': 'NCT05750966', 'acronym': 'COBRA', 'briefTitle': 'Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Very Short-course Versus Standard Course Antibiotic Therapy in Patients With Acute ChOlangitis After Adequate Endoscopic BiliaRy drAinage', 'orgStudyIdInfo': {'id': '2022.0292'}, 'secondaryIdInfos': [{'id': '2022-002624-12', 'type': 'EUDRACT_NUMBER'}, {'id': 'NL80410.029.22', 'type': 'OTHER', 'domain': 'NL number CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Very short-course antibiotics', 'description': "The antibiotic regimens will be according to the local hospital's antibiotic guideline for cholangitis (e.g. dosage form, dosage, frequency)and/or the national SWAB guideline in the Netherlands. In the experimental group, duration of ABT after adequate drainage will be 1 day. The duration will be 4 days and can be extended to 7 days in case of gram-negative bacteraemia, according to the national SWAB guideline regarding gram-negative sepsis.", 'interventionNames': ['Drug: cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (24 hours)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard course antibiotics', 'description': "The antibiotic regimens will be according to the local hospital's antibiotic guideline for cholangitis, which are based on the previously mentioned national SWAB guideline. This means that the type of ABT, dosage and frequency will be comparable to the experimental group.\n\nIn the comparator group treatment duration with ABT after ERCP will be according to the international well known and widely used TG18. The duration will be 4 days and can be extended to 7 days in case of gram-negative bacteraemia, according to the national SWAB guideline regarding gram-negative sepsis.", 'interventionNames': ['Drug: cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (4 to 7 days)']}], 'interventions': [{'name': 'cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (24 hours)', 'type': 'DRUG', 'otherNames': ['ceftriaxone', 'gentamicin', 'cefuroxim', 'ciprofloxacin'], 'description': 'The duration of antibiotics is 24 hours after adequate biliary drainage. The choice of antibiotics will be according to local protocol and/or national Dutch SWAB guidelines. The most common antibiotics are described above, but this can differ based on allergies, local protocol or previous cultures. Drug classes may include: aminoglycosides, carbapenems, cefalosporins, fluorquinolones, sulfonamides, penicillines.', 'armGroupLabels': ['Very short-course antibiotics']}, {'name': 'cefrtriaxone, gentamicin, cefuroxim, ciprofloxin or other antibiotics according to local guideline (4 to 7 days)', 'type': 'DRUG', 'otherNames': ['ceftriaxone', 'gentamicin', 'cefuroxim', 'ciprofloxacin'], 'description': 'The duration of antibiotics is 4 to 7 days after adequate biliary drainage. The choice of antibiotics will be according to local protocol and/or national Dutch SWAB guidelines. The most common antibiotics are described above, but this can differ based on allergies, local protocol or previous cultures. Drug classes may include: aminoglycosides, carbapenems, cefalosporins, fluorquinolones, sulfonamides, penicillines.', 'armGroupLabels': ['Standard course antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1315 RA', 'city': 'Almere Stad', 'state': 'Flevoland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marius Munneke, MD PhD', 'role': 'CONTACT', 'email': 'mmunneke@flevoziekenhuis.nl', 'phone': '0368688888'}, {'name': 'Marius Munneke, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Flevoziekenhuis', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'zip': '6815 AD', 'city': 'Arnhem', 'state': 'Gelderland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jan Maarten Vrolijk, MD', 'role': 'CONTACT', 'email': 'JVrolijk@rijnstate.nl', 'phone': '0880056800'}, {'name': 'Jan Maarten Vrolijk, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rijnstate Ziekenhuis', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Foke Delft, van, MD', 'role': 'CONTACT', 'email': 'Foke.vanDelft@radboudumc.nl', 'phone': '0243619190'}, {'name': 'Foke Delft, van, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radboud umc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Adriaan Tan, MD PhD', 'role': 'CONTACT', 'email': 'a.tan@cwz.nl', 'phone': '0243658070'}, {'name': 'Adriaan Tan, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Canisius Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jan-Werner Poley, MD PhD', 'role': 'CONTACT', 'email': 'jan.werner.poley@mumc.nl', 'phone': '0433875100'}, {'name': 'Jan-Werner Poley, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maastricht UMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '5223 GZ', 'city': "'s-Hertogenbosch", 'state': 'North Brabant', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bob CH Scheffer, MD PhD', 'role': 'CONTACT', 'email': 'b.scheffer@jbz.nl', 'phone': '0735333051'}, {'name': 'Bob CH Scheffer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Lennard Gilissen, MD PhD', 'role': 'CONTACT', 'email': 'lennard.gilissen@catharinaziekenhuis.nl', 'phone': '0402399750'}, {'name': 'Lennard Gilissen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '5022 GC', 'city': 'Tilburg', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wouter L. Hazen, MD PhD', 'role': 'CONTACT', 'email': 'wl.hazen@etz.nl', 'phone': '0132213076'}, {'name': 'Wouter L. Hazen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Elisabeth Tweesteden Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '1186 AM', 'city': 'Amstelveen', 'state': 'North Holland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Karam Boparai, MD PhD', 'role': 'CONTACT', 'email': 'k.boparai@zha.nl', 'phone': '0207557023'}, {'name': 'Karam Boparai, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amstelland Ziekenhuis', 'geoPoint': {'lat': 52.30083, 'lon': 4.86389}}, {'zip': '1081 HZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rogier P. Voermans, MD PhD', 'role': 'CONTACT', 'email': 'r.p.voermans@amsterdamumc.nl', 'phone': '0650091301'}, {'name': 'Rogier P. Voermans, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1091 AC', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sjoerd D. Kuiken, MD PhD', 'role': 'CONTACT', 'email': 's.kuiken@olvg.nl', 'phone': '0205108777'}, {'name': 'Sjoerd D. Kuiken, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2134 TM', 'city': 'Hoofddorp', 'state': 'North Holland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ellert J. Soest, van, MD PhD', 'role': 'CONTACT', 'email': 'e.van.soest@spaarnegasthuis.nl', 'phone': '0232240075'}, {'name': 'Ellert J. Soest, van, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spaarne Gasthuis', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'zip': '1624 AR', 'city': 'Hoorn', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Pim W. Weijenborg, MD PhD', 'role': 'CONTACT', 'email': 'p.w.weijenborg@dijklander.nl', 'phone': '0229257823'}, {'name': 'Pim W. Weijenborg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dijklander Ziekenhuis', 'geoPoint': {'lat': 52.6425, 'lon': 5.05972}}, {'zip': '1502 DV', 'city': 'Zaandam', 'state': 'North Holland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Dirk Schölvinck, MD', 'role': 'CONTACT', 'email': 'Scholvinck.D@zaansmc.nl', 'phone': '0756501230'}, {'name': 'Dirk Schölvinck, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zaans Medisch Centrum', 'geoPoint': {'lat': 52.43854, 'lon': 4.82643}}, {'zip': '7416 SE', 'city': 'Deventer', 'state': 'Overijssel', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Frank Borg, ten, MD PhD', 'role': 'CONTACT', 'email': 'frank2pad@icloud.com', 'phone': '0570535105'}, {'name': 'Frank Borg, ten, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Deventer Ziekenhuis', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'zip': '7512 KZ', 'city': 'Enschede', 'state': 'Overijssel', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Niels Venneman, MD PhD', 'role': 'CONTACT', 'email': 'N.Venneman@mst.nl', 'phone': '0534872410'}, {'name': 'Niels Venneman, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '8025 AB', 'city': 'Zwolle', 'state': 'Overijssel', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Alexander C. Poen, MD PhD', 'role': 'CONTACT', 'email': 'a.c.poen@isala.nl', 'phone': '0886246223'}, {'name': 'Alexander C. Poen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Isala', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'state': 'Provincie Friesland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Klaas Linde, van der, MD PhD', 'role': 'CONTACT', 'email': 'k.v.d.linde@mcl.nl', 'phone': '0582866950'}, {'name': 'Klaas Linde, van der, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medisch Centrum Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'zip': '9713 GZ', 'city': 'Groningen', 'state': 'Provincie Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Frans Heide, van der, MD PhD', 'role': 'CONTACT', 'email': 'f.van.der.heide@umcg.nl', 'phone': '0503619259'}, {'name': 'Frans Heide, van der, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '9728 NT', 'city': 'Groningen', 'state': 'Provincie Groningen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Willem J. Thijs, MD', 'role': 'CONTACT', 'email': 'ThijsW@MZH.nl', 'phone': '0505245940'}, {'name': 'Willem J. 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