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

Sponsored by:	Medical Corps, Israel Defense Force
Information provided by:	Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:	NCT00237016

Purpose

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.

Condition	Intervention	Phase
Relapsing Fever, Tick-Borne Jarisch Herxheimer Reaction	Drug: doxycycline treatment	Phase II Phase III

MedlinePlus related topics: Fever

Drug Information available for: Doxycycline Doxycycline calcium Doxycycline hyclate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Further study details as provided by Medical Corps, Israel Defense Force:

Estimated Enrollment:	140
Study Start Date:	April 2002
Estimated Study Completion Date:	April 2003

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237016

Locations

Israel
Israel Defence Forces
Tel Hashomer, Israel

Sponsors and Collaborators

Medical Corps, Israel Defense Force

Investigators

Principal Investigator:

Tal Hasin, MD

Medical corps, Israel Defence Forces

More Information

Publications:

Galun E, Ben-Chetrit E. Possible prevention of tick-borne relapsing fever in patients infected with Borrelia recurrentis. J Infect Dis. 1984 Oct;150(4):617. No abstract available.

Korenberg EI, Vorobyeva NN, Moskvitina HG, Gorban' LYa. Prevention of borreliosis in persons bitten by infected ticks. Infection. 1996 Mar-Apr;24(2):187-9.

Raz R, Sharir R, Bennett M. Prevention of Borrelia recurrentis infection with tetracycline. Isr J Med Sci. 1987 Mar;23(3):221. No abstract available.

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.

Perine PL, Krause DW, Awoke S, McDade JE. Single-dose doxycycline treatment of louse-borne relapsing fever and epidemic typhus. Lancet. 1974 Sep 28;2(7883):742-4. No abstract available.

Study ID Numbers:	RF1
Study First Received:	October 7, 2005
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00237016
Health Authority:	Israel: Ethics Commission

Study placed in the following topic categories:

Bacterial Infections
Fever
Signs and Symptoms
Borrelia Infections

Relapsing Fever
Doxycycline
Tick-Borne Diseases
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Antimalarials
Anti-Infective Agents
Anti-Bacterial Agents
Antiparasitic Agents
Antiprotozoal Agents

Spirochaetales Infections
Therapeutic Uses
Body Temperature Changes
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009