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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. Identifier: NCT00237016
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : October 24, 2008
Information provided by:
Medical Corps, Israel Defense Force

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.

Condition or disease Intervention/treatment Phase
Relapsing Fever, Tick-Borne Jarisch Herxheimer Reaction Drug: doxycycline treatment Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Study Start Date : April 2002
Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237016

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Israel Defence Forces
Tel Hashomer, Israel
Sponsors and Collaborators
Medical Corps, Israel Defense Force
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Principal Investigator: Tal Hasin, MD Medical corps, Israel Defence Forces
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00237016    
Other Study ID Numbers: RF1
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: April 2003
Additional relevant MeSH terms:
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Relapsing Fever
Body Temperature Changes
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents