Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00564577 · ClinicalTrials.gov registry record · Phase 1
Dose-Finding Study of WS6788A and LSN03-016011/A Enterotoxigenic E. Coli ETEC Challenge Strains That Express CS17
A Phase 1 study of Travelers' Diarrhea, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT00564577 is a Phase 1 study of Travelers' Diarrhea that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 13 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT00564577, a Phase 1 study of Travelers' Diarrhea, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
Study Summary
This will be a strain and dose-finding study in which LSN03-016011/A ETEC will be administered at a starting inoculum of 5x108 cfu to 5 subjects to establish a human disease model. If 80% attack rate (AR) is achieved without high output diarrhea, the same inoculum will be given to 10 more subjects for confirmation of AR. If 80% AR is not achieved, attack rate and severity of disease will be evaluated to determine if the dose should be increased. The same sequence may be conducted with WS6788A if applicable. If the LSN strain causes high output diarrhea the dose will be adjusted down and further dose characterization continued. An iterative process will be used to select the optimal strain and dose with each step reviewed and approved by the medical monitor.
Conditions Studied
Interventions
- BIOLOGICAL CFA/I and CS17 challenge strain
Study Locations (2)
Maryland
- Center for Immunization Research - Johns Hopkins Bloomberg School of Public Health - Baltimore
- General Clinical Research Center of the Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-06-13 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00564577
The ClinicalTrials.gov registry entry for NCT00564577 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Travelers' Diarrhea appearing as the primary indexed condition, and to 1 intervention - of which CFA/I and CS17 challenge strain is the first listed.
NCT00564577 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00564577 about?
NCT00564577 is a clinical study titled "Dose-Finding Study of WS6788A and LSN03-016011/A Enterotoxigenic E. Coli ETEC Challenge Strains That Express CS17". This will be a strain and dose-finding study in which LSN03-016011/A ETEC will be administered at a starting inoculum of 5x108 cfu to 5 subjects to establish a human disease model. If 80% attack rate (AR) is achieved without high output diarrhea, the same inoculum will be given to 10 more subjects f...
What is the current status of trial NCT00564577?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2006-09. Estimated completion is 2007-06-13.
What conditions does trial NCT00564577 study?
This clinical trial studies the following conditions: Travelers' Diarrhea.
What interventions are being tested in trial NCT00564577?
The interventions under investigation include: CFA/I and CS17 challenge strain (BIOLOGICAL).
Who is sponsoring clinical trial NCT00564577?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00564577 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Travelers' Diarrhea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.