Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

This study has been completed.
Sponsor:
Information provided by:
Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT00237016
First received: October 7, 2005
Last updated: October 23, 2008
Last verified: April 2003
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
ClinicalTrials.gov Identifier: NCT00237016     History of Changes
Other Study ID Numbers: RF1
Study First Received: October 7, 2005
Last Updated: October 23, 2008
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on October 19, 2014