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Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237016
First Posted: October 12, 2005
Last Update Posted: October 24, 2008
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.
Information provided by:
Medical Corps, Israel Defense Force
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Resource links provided by NLM:


Further study details as provided by Medical Corps, Israel Defense Force:

Estimated Enrollment: 140
Study Start Date: April 2002
Estimated Study Completion Date: April 2003
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00237016


Locations
Israel
Israel Defence Forces
Tel Hashomer, Israel
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
Principal Investigator: Tal Hasin, MD Medical corps, Israel Defence Forces
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00237016     History of Changes
Other Study ID Numbers: RF1
First Submitted: October 7, 2005
First Posted: October 12, 2005
Last Update Posted: October 24, 2008
Last Verified: April 2003

Additional relevant MeSH terms:
Borrelia Infections
Tick-Borne Diseases
Fever
Relapsing Fever
Body Temperature Changes
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents