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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: Completed Phase 1 study of Travelers' Diarrhea, sponsored by Johns Hopkins Bloomberg School of Public Health.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00564577 record still lists
NCT00564577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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
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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.
Where NCT00564577's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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