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Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00237016
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : October 24, 2008
Sponsor:
Information provided by:
Medical Corps, Israel Defense Force

Tracking Information
First Submitted Date  ICMJE October 7, 2005
First Posted Date  ICMJE October 12, 2005
Last Update Posted Date October 24, 2008
Study Start Date  ICMJE April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Official Title  ICMJE Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
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 100mg/d 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE
  • Relapsing Fever, Tick-Borne
  • Jarisch Herxheimer Reaction
Intervention  ICMJE Drug: doxycycline treatment
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October¬†7,¬†2005)
140
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • suspected exposure to tick-borne relapsing fever
  • after returning from field exercise in a tick-borne relapsing fever infected area
  • having a tick bite or staying in field in close proximity to a subject with tick bite sign

Exclusion Criteria:

  • known sensitivity to tetracycline or doxycycline
  • febrile illness on recruitment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00237016
Other Study ID Numbers  ICMJE RF1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medical Corps, Israel Defense Force
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tal Hasin, MD Medical corps, Israel Defence Forces
PRS Account Medical Corps, Israel Defense Force
Verification Date April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP