Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2002
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedDecember 19, 2024
December 1, 2024
October 7, 2005
December 15, 2024
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- known sensitivity to tetracycline or doxycycline
- febrile illness on recruitment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Israel Defence Forces
Tel Litwinsky, Israel
Related Publications (2)
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. doi: 10.1056/NEJM200107123450201.
PMID: 11450675BACKGROUNDHasin T, Davidovitch N, Cohen R, Dagan T, Romem A, Orr N, Klement E, Lubezky N, Kayouf R, Sela T, Keller N, Derazne E, Halperin T, Yavzori M, Grotto I, Cohen D. Postexposure treatment with doxycycline for the prevention of tick-borne relapsing fever. N Engl J Med. 2006 Jul 13;355(2):148-55. doi: 10.1056/NEJMoa053884.
PMID: 16837678DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tal Hasin, MD
Medical corps, Israel Defence Forces
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
April 1, 2002
Study Completion
April 1, 2003
Last Updated
December 19, 2024
Record last verified: 2024-12