Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever - Tabular View

Tracking Information

First Received Date ^ICMJE

October 7, 2005

Last Updated Date

October 23, 2008

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00237016 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Official Title ^ICMJE

Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

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

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Relapsing Fever, Tick-Borne
Jarisch Herxheimer Reaction

Intervention ^ICMJE

Drug: doxycycline treatment

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Completion Date

April 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00237016

Responsible Party

Study ID Numbers ^ICMJE

RF1

Study Sponsor ^ICMJE

Medical Corps, Israel Defense Force

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Tal Hasin, MD

Medical corps, Israel Defence Forces

Information Provided By

Medical Corps, Israel Defense Force

Verification Date

April 2003

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