Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

• ClinicalTrials.gov Identifier: NCT00237016
• Recruitment Status: Completed
• First Posted: October 12, 2005
• Last Update Posted: October 24, 2008
• Sponsor: Medical Corps, Israel Defense Force
• Information provided by: Medical Corps, Israel Defense Force

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Relapsing Fever, Tick-Borne; Jarisch Herxheimer Reaction	Drug: doxycycline treatment	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Official Title: Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
• Study Start Date: April 2002
• Study Completion Date: April 2003

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

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:

Nadelman RB, Nowakowski J, Fish D, Falco RC, Freeman K, McKenna D, Welch P, Marcus R, Agüero-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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hasin 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.

• ClinicalTrials.gov Identifier: NCT00237016
• Other Study ID Numbers: RF1
• First Posted: October 12, 2005
• Last Update Posted: October 24, 2008
• Last Verified: April 2003

Additional relevant MeSH terms:

Relapsing Fever; Fever; Body Temperature Changes; Borrelia Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Tick-Borne Diseases; Spirochaetales Infections; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents