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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
Official Title:	Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Resource links provided by NLM:

MedlinePlus related topics: Fever Lyme Disease

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

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.

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

Additional relevant MeSH terms:

Fever
Relapsing Fever
Body Temperature Changes
Signs and Symptoms
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections

Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 12, 2012