Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Phase 2

Completed

• Conditions: Relapsing Fever, Tick-borne; Jarisch Herxheimer Reaction

• Registration Number: NCT00237016
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2003-04
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Israel Defence Forces; 🇮🇱 Tel Hashomer, Israel