Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00237016
Status:
COMPLETED
Last Update Posted:
2008-10-24
First Post:
2005-10-07
Brief Title:
Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Sponsor:
Medical Corps Israel Defense Force
Organization:
Medical Corps Israel Defense Force
Study Overview
Official Title:
Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Status:
COMPLETED
Status Verified Date:
2003-04
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:
Abstract Background Tick-Borne Relapsing Fever TBRF is an acute febrile illness In Israel TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks We examined the safety and efficacy of a post exposure treatment policy to prevent TBRF
Methods In a double blind placebo controlled trial 93 healthy volunteers with suspected tick exposure 51 with bite signs and 42 contacts were randomly assigned to receive either Doxycycline 200 mg for the first day and 100mgd for 4 days or placebo approximately 2 days after contact Blood smears were examined for Borrelia at inclusion and during fever rise Serology for Lyme disease cross- reactivity and PCR for Borrelia GlpQ gene were also performed Cases of TBRF were defined as subjects having fever and a positive blood smear
Methods In a double blind placebo controlled trial 93 healthy volunteers with suspected tick exposure 51 with bite signs and 42 contacts were randomly assigned to receive either Doxycycline 200 mg for the first day and 100mgd for 4 days or placebo approximately 2 days after contact Blood smears were examined for Borrelia at inclusion and during fever rise Serology for Lyme disease cross- reactivity and PCR for Borrelia GlpQ gene were also performed Cases of TBRF were defined as subjects having fever and a positive blood smear
Detailed Description:
None
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