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CompletedNCT00237016Updated Dec 19, 2024

Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever

A Phase 2/3 interventional study of doxycycline treatment in Relapsing Fever, Tick-borne and Jarisch Herxheimer Reaction, sponsored by Medical Corps, Israel Defense Force. Completed at 1 site in Israel. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Medical Corps, Israel Defense Force · Phase 2/3 and Interventional

Phase
Phase 2/3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Sex
All
01

Study 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.

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Conditions studied

  • Relapsing Fever, Tick-borne
  • Jarisch Herxheimer Reaction
03

In context

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • known sensitivity to tetracycline or doxycycline
  • febrile illness on recruitment
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Study design

Phase
Phase 2 / Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
140 participants

Interventions

  • Drugdoxycycline treatment
06

Study locations

1 site
  • Israel Defence Forces
    Tel Hashomer, Israel
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References and documents

Publications

  • 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. PubMed 11450675 ↗
  • 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. PubMed 16837678 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00237016
Lead sponsor
Medical Corps, Israel Defense Force
First posted
Oct 12, 2005
Start date
Apr 2002
Completion
Apr 2003
Last update
Dec 19, 2024

Study contacts

Tal Hasin, MD
principal investigator · Medical corps, Israel Defence Forces
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Other studies in this condition

Relapsing Fever

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Medical Corps, Israel Defense Force

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