Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198796
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2005-09-13
Brief Title:
Dose-finding Study of WS6788A DS37-4 and H10407 Enterotoxigenic Escherichia Coli ETEC Challenge Strains
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Dose-finding Study of WS6788A DS37-4 and H10407 Enterotoxigenic E Coli ETEC Challenge Strains That Express Colonization Factors CS17 and CFAI
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Five subjects will be admitted to the General Clinical Research Center GCRC The next day they will eat a light breakfast fast for 90 minutes ingest ETEC strain H10407 and fast for 90 more minutes After this challenge they will be monitored closely and all stools will be collected graded and weighed On Day 5 or sooner if indicated they will begin antibiotics to eradicate the challenge strain They will be scheduled for discharge on Day 7 but may leave a few days earlier if early antibiotic treatment is given
Hypothesis
A challenge dose of 109 colony forming unit CFU of ETEC strain H10407 will cause diarrhea in at least 60 of subjects
Hypothesis
A challenge dose of 109 colony forming unit CFU of ETEC strain H10407 will cause diarrhea in at least 60 of subjects
Detailed Description:
The rationale for validation H10407 in the challenge study proposed at Johns Hopkins University is that this initial challenge study will support additional challenge studies planned for the future In these future studies a bovine milk immunoglobulin containing high levels of antibodies specific for colonization factor antigen CFAI or CFAI-derived colonization factor will be investigated as a potential oral prophylaxis to neutralize subsequent challenge against CFAI-expressing H10407 in the clinical setting The goal here is therefore to validate a challenge dose of 1x109 h10407 organisms in the hands of the Johns Hopkins investigative team and to then use this dose in the future prophylaxischallenge studies Challenge doses equal to or comparable to the 1x109 dose proposed for the Johns Hopkins University JHU study have been used in 6 of the 9 challenge studies that have been done with the H10407 strain The subsequent challenge studies using H10407 will be registered as part of other protocols
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHR H22031028A2 | OTHER | JHSPH IRB | None |