Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-04-30

Brief Summary

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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

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Conditions

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Relapsing Fever, Tick-borne Jarisch Herxheimer Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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doxycycline treatment

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Tal Hasin, MD

Role: PRINCIPAL_INVESTIGATOR

Medical corps, Israel Defence Forces

Locations

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Israel Defence Forces

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND

PMID: 11450675 (View on PubMed)

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. doi: 10.1056/NEJMoa053884.

Reference Type DERIVED

PMID: 16837678 (View on PubMed)

Other Identifiers

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RF1

Identifier Type: -

Identifier Source: org_study_id