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ETEC Logistics Trial (TREK) (Trek)

13. marts 2012 opdateret af: Intercell USA, Inc.

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

evaluate 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

201

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Long Beach, California, Forenede Stater, 90806
        • West Coast Clinical Trials
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60610
        • Radiant Research
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins University, Bloomberg School of Public Health
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55430
        • Twin Cities Clinical Research
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Advanced Biomedical Research
    • New York
      • Ithica, New York, Forenede Stater, 14850
        • Asthma Allergy & Associates
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43212
        • Radiant Research
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Radiant Research
      • Houston, Texas, Forenede Stater, 77024
        • Breco Research
      • Houston, Texas, Forenede Stater, 77030
        • Center for Infectious Diseases, The University of Texas Health Science Center at Houston
      • San Antonio, Texas, Forenede Stater, 78229
        • Radiant Research
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Jean Brown Research
    • Washington
      • Tacoma, Washington, Forenede Stater, 98418
        • Northwest Kinetics
  • Guatemala
      • Antigua Guatemala, Guatemala, 03001
        • Private Clinic Antigua
  • Mexico
    • Guanajuata
      • San Miguel de Allende, Guanajuata, Mexico, 37700
        • Private Clinic San Miguel
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44690
        • Private Clinic Guadalajara
    • Marina Vallarta
      • Puerto Vallarta, Marina Vallarta, Mexico, 48334
        • AmeriMed Hospital
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Private Clinic Cuernavaca
    • Quintana Roo
      • Cancun, Quintana Roo, Mexico, 77500
        • Hospital Americano

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 64 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy adult men and women 18-64 years of age inclusive at screening
  • Signed Informed Consent form
  • Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days)
  • 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.

Exclusion Criteria:

  • Clinically significant abnormalities as determined by the Investigator/clinician during physical inspection
  • Received investigational product from 30 days before date of first vaccination or during the entire study period
  • Ever received LT, ETEC, or cholera vaccine
  • History of traveler's diarrhea within the previous year
  • Travel to a developing country within the last year
  • Women who are pregnant or breastfeeding
  • History of achlorhydria
  • Evidence of immunosuppression, including concomitant immunosuppressive therapy; fever > 99.5°F (37.5°C) on day of vaccination
  • Current problems with alcohol or substance abuse
  • An employee of the study clinic
  • Sensitivity or allergy to any of the vaccine components
  • History of significant blood loss, blood product donation, or blood product recipient in the previous 60 days
  • Planned use of Imodium or antibiotics for self treatment of diarrhea during the study period
  • Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; and
  • Medical history of acute or chronic GI illness or major GI surgery.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group 1
Group 1 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 37.5µg LT
Biologisk: Heat-Labile Enterotoxin of Escherichia coli (LT)
Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
Placebo komparator: Group 2
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)
Biologisk: Placebo
The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo
Tidsramme: From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
From vaccination 1 to completion of Day 180 follow-up, about a seven month time period

Sekundære resultatmål

Resultatmål
Tidsramme
Stool frequency per episode of ETEC illness in placebo recipients
Tidsramme: Duration of stay in Mexico or Guatemala assessed up to four weeks
Duration of stay in Mexico or Guatemala assessed up to four weeks
Immunogenicity of LT delivered by TCI
Tidsramme: at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity.
Tidsramme: Baseline through six months post return from Latin America. A period of about six months.
Baseline through six months post return from Latin America. A period of about six months.
Incidence of vaccine preventable outcome in placebo and LT patch recipients.
Tidsramme: Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Intercell USA, Inc.

Efterforskere

  • Ledende efterforsker: Herbert L. DuPont, MD, Center for Infectious Diseases, The University of Texas Health Science Center at Houston
  • Ledende efterforsker: Robin McKenzie, MD, Johns Hopkins University, Bloomberg School of Public Health
  • Ledende efterforsker: Rama Yerramsetti, Breco Research, Houston, TX
  • Ledende efterforsker: William P Jennings, Radiant Research, San Antonio, TX
  • Ledende efterforsker: Yu-Luen Hsu, West Coast Clinical Trials, Long Beach, CA
  • Ledende efterforsker: Christopher A Smith, Asthma & Allergy Associates, Ithaca, NY
  • Ledende efterforsker: Benno G Roesch, Advanced Biomedical Research, Hackensack, NJ
  • Ledende efterforsker: Jeffrey G Geohas, Radiant Research, Chicago, IL
  • Ledende efterforsker: Gilbert Podolsky, Jean Brown Research, Salt Lake City, UT
  • Ledende efterforsker: Thomas Lagen, Northwest Kinetics, Tacoma, WA
  • Ledende efterforsker: Roy M Fleischmann, Radiant Research, Dallas, TX
  • Ledende efterforsker: Douglas R Schumacher, Radiant Research, Columbus, OH
  • Ledende efterforsker: Norman M Lunde, Twin Cities Clinical Research, Minneapolis, MN
  • Ledende efterforsker: Francisco G Sandoval, Universidad Autonoma De Guadalajara, Mexico
  • Ledende efterforsker: Juan Hector M Romero, Universidad Autonoma Guadalajara, Mexico
  • Ledende efterforsker: Jaime B Gerson, University of Texas, Cuernavaca, Mexico
  • Ledende efterforsker: Edwin Asturias, Universidad del Valle de Guatemala (Antigua)
  • Ledende efterforsker: Roberto Garcia, AmeriMed Puerto Vallarta, Mexico
  • Ledende efterforsker: Martha V Serrato, Hospital Americano, Cancun, Mexico
  • Ledende efterforsker: Robert Maxwell, Private Clinic, San Miguel de Allende, Mexico

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2006

Primær færdiggørelse (Faktiske)

1. januar 2007

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

13. august 2007

Først indsendt, der opfyldte QC-kriterier

14. august 2007

Først opslået (Skøn)

15. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. marts 2012

Sidst verificeret

1. marts 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ELT206

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diarré

Kliniske forsøg med Heat-Labile Enterotoxin of Escherichia coli (LT)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Qatar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner