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

October 7, 2005
October 23, 2008
April 2002
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Complete list of historical versions of study NCT00237016 on ClinicalTrials.gov Archive Site
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Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

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.

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Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
  • Relapsing Fever, Tick-Borne
  • Jarisch Herxheimer Reaction
Drug: doxycycline treatment
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Nadelman RB, Nowakowski J, Fish D, Falco RC, Freeman K, McKenna D, Welch P, Marcus R, Aguero-Rosenfeld ME, Dennis DT, Wormser GP; Tick Bite Study Group. Prophylaxis with single-dose doxycycline for the prevention of Lyme disease after an Ixodes scapularis tick bite. N Engl J Med. 2001 Jul 12;345(2):79-84.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
April 2003
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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
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00237016
RF1
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Medical Corps, Israel Defense Force
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Principal Investigator: Tal Hasin, MD Medical corps, Israel Defence Forces
Medical Corps, Israel Defense Force
April 2003

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