Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Jarisch Herxheimer Reaction Clinical Trial

Official title:

Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237016
• Other study ID #: RF1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 7, 2005
• Last updated: October 23, 2008
• Start date: April 2002
• Est. completion date: April 2003

Study information

• Verified date: April 2003
• Source: Medical Corps, Israel Defense Force
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Fever
• Jarisch Herxheimer Reaction
• Relapsing Fever
• Relapsing Fever, Tick-Borne

Intervention

Drug:
• doxycycline treatment

Locations

Country	Name	City	State
Israel	Israel Defence Forces	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Nadelman RB, Nowakowski J, Fish D, Falco RC, Freeman K, McKenna D, Welch P, Marcus R, Agüero-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. — View Citation