Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-30 @ 6:05 AM
Study NCT ID:
NCT00516659
Status:
COMPLETED
Last Update Posted:
2012-03-14
First Post:
2007-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ETEC Logistics Trial (TREK)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D004927', 'term': 'Escherichia coli Infections'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-13', 'studyFirstSubmitDate': '2007-08-13', 'studyFirstSubmitQcDate': '2007-08-14', 'lastUpdatePostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Enterotoxigenic Escherichia coli (ETEC) illness defined as a diarrheal episode associated with an LT, LT/ST, or ST-positive ETEC strain isolated from a sample of a stool', 'timeFrame': 'during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.'}, {'measure': 'Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo', 'timeFrame': 'From vaccination 1 to completion of Day 180 follow-up, about a seven month time period'}], 'secondaryOutcomes': [{'measure': 'Stool frequency per episode of ETEC illness in placebo recipients', 'timeFrame': 'Duration of stay in Mexico or Guatemala assessed up to four weeks'}, {'measure': 'Immunogenicity of LT delivered by TCI', 'timeFrame': 'at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival'}, {'measure': 'Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity.', 'timeFrame': 'Baseline through six months post return from Latin America. A period of about six months.'}, {'measure': 'Incidence of vaccine preventable outcome in placebo and LT patch recipients.', 'timeFrame': 'Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ETEC', "Traveler's diarrhea", 'TCI', 'patch vaccine', 'diarrhea prevention', 'epidemiology ETEC', 'Escherichia coli'], 'conditions': ['Diarrhea']}, 'referencesModule': {'references': [{'pmid': '18554712', 'type': 'DERIVED', 'citation': "Frech SA, Dupont HL, Bourgeois AL, McKenzie R, Belkind-Gerson J, Figueroa JF, Okhuysen PC, Guerrero NH, Martinez-Sandoval FG, Melendez-Romero JH, Jiang ZD, Asturias EJ, Halpern J, Torres OR, Hoffman AS, Villar CP, Kassem RN, Flyer DC, Andersen BH, Kazempour K, Breisch SA, Glenn GM. Use of a patch containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase II, randomised, double-blind, placebo-controlled field trial. Lancet. 2008 Jun 14;371(9629):2019-25. doi: 10.1016/S0140-6736(08)60839-9."}], 'seeAlsoLinks': [{'url': 'http://www.trekstudy.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with ETEC occurring after transcutaneous immunization in a field setting.', 'detailedDescription': 'The primary objectives of the study are to evaluate the incidence of ETEC illness in a field setting and to compare the safety of LT delivered by TCI with placebo. The secondary objectives include, but are not limited to:\n\nevaluate the stool frequency per episode of ETEC illness in placebo recipients, to evaluate the immunogenicity of LT delivered by TCI, to evaluate the incidence of IBS following travel to areas of ETEC endemnicity, and to evaluate the incidence of VPO in placebo and LT patch recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult men and women 18-64 years of age inclusive at screening\n* Signed Informed Consent form\n* Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days)\n* If female who is not post-menopausal or surgically sterile, negative pregnancy test (within 24 hours prior to vaccination) and agreement to employ an effective form of birth control or practice abstinence through the end of the study.\n\nExclusion Criteria:\n\n* Clinically significant abnormalities as determined by the Investigator/clinician during physical inspection\n* Received investigational product from 30 days before date of first vaccination or during the entire study period\n* Ever received LT, ETEC, or cholera vaccine\n* History of traveler's diarrhea within the previous year\n* Travel to a developing country within the last year\n* Women who are pregnant or breastfeeding\n* History of achlorhydria\n* Evidence of immunosuppression, including concomitant immunosuppressive therapy; fever \\> 99.5°F (37.5°C) on day of vaccination\n* Current problems with alcohol or substance abuse\n* An employee of the study clinic\n* Sensitivity or allergy to any of the vaccine components\n* History of significant blood loss, blood product donation, or blood product recipient in the previous 60 days\n* Planned use of Imodium or antibiotics for self treatment of diarrhea during the study period\n* Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; and\n* Medical history of acute or chronic GI illness or major GI surgery."}, 'identificationModule': {'nctId': 'NCT00516659', 'acronym': 'Trek', 'briefTitle': 'ETEC Logistics Trial (TREK)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intercell USA, Inc.'}, 'officialTitle': 'A Phase II, Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Epidemiology of Natural Infection With Enterotoxigenic Escherichia Coli Occurring After Transcutaneous Immunization in a Field Setting', 'orgStudyIdInfo': {'id': 'ELT206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Group 1 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 37.5µg LT', 'interventionNames': ['Biological: Heat-Labile Enterotoxin of Escherichia coli (LT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'Group 2 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 0µg LT (placebo patch containing no LT)', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Heat-Labile Enterotoxin of Escherichia coli (LT)', 'type': 'BIOLOGICAL', 'description': 'Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.', 'armGroupLabels': ['Group 1']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Trials', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University, Bloomberg School of Public Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55430', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Twin Cities Clinical Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Advanced Biomedical Research', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14850', 'city': 'Ithica', 'state': 'New York', 'country': 'United States', 'facility': 'Asthma Allergy & Associates'}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Breco Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Infectious Diseases, The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98418', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Kinetics', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '03001', 'city': 'Antigua Guatemala', 'country': 'Guatemala', 'facility': 'Private Clinic Antigua', 'geoPoint': {'lat': 14.55636, 'lon': -90.7332}}, {'zip': '37700', 'city': 'San Miguel de Allende', 'state': 'Guanajuata', 'country': 'Mexico', 'facility': 'Private Clinic San Miguel', 'geoPoint': {'lat': 20.91528, 'lon': -100.74389}}, {'zip': '44690', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Private Clinic Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '48334', 'city': 'Puerto Vallarta', 'state': 'Marina Vallarta', 'country': 'Mexico', 'facility': 'AmeriMed Hospital', 'geoPoint': {'lat': 20.617, 'lon': -105.23018}}, {'zip': '62250', 'city': 'Cuernavaca', 'state': 'Morelos', 'country': 'Mexico', 'facility': 'Private Clinic Cuernavaca', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}, {'zip': '77500', 'city': 'Cancún', 'state': 'Quintana Roo', 'country': 'Mexico', 'facility': 'Hospital Americano', 'geoPoint': {'lat': 21.17429, 'lon': -86.84656}}], 'overallOfficials': [{'name': 'Herbert L. DuPont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Infectious Diseases, The University of Texas Health Science Center at Houston'}, {'name': 'Robin McKenzie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University, Bloomberg School of Public Health'}, {'name': 'Rama Yerramsetti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Breco Research, Houston, TX'}, {'name': 'William P Jennings', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiant Research, San Antonio, TX'}, {'name': 'Yu-Luen Hsu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Coast Clinical Trials, Long Beach, CA'}, {'name': 'Christopher A Smith', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asthma & Allergy Associates, Ithaca, NY'}, {'name': 'Benno G Roesch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Biomedical Research, Hackensack, NJ'}, {'name': 'Jeffrey G Geohas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiant Research, Chicago, IL'}, {'name': 'Gilbert Podolsky', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jean Brown Research, Salt Lake City, UT'}, {'name': 'Thomas Lagen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwest Kinetics, Tacoma, WA'}, {'name': 'Roy M Fleischmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiant Research, Dallas, TX'}, {'name': 'Douglas R Schumacher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiant Research, Columbus, OH'}, {'name': 'Norman M Lunde', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Twin Cities Clinical Research, Minneapolis, MN'}, {'name': 'Francisco G Sandoval', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Autonoma De Guadalajara, Mexico'}, {'name': 'Juan Hector M Romero', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Autonoma Guadalajara, Mexico'}, {'name': 'Jaime B Gerson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas, Cuernavaca, Mexico'}, {'name': 'Edwin Asturias', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad del Valle de Guatemala (Antigua)'}, {'name': 'Roberto Garcia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AmeriMed Puerto Vallarta, Mexico'}, {'name': 'Martha V Serrato', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Americano, Cancun, Mexico'}, {'name': 'Robert Maxwell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Private Clinic, San Miguel de Allende, Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intercell USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}