Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Information source: Medical Corps, Israel Defense Force
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsing Fever, Tick-Borne; Jarisch Herxheimer Reaction
Intervention: doxycycline treatment (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Medical Corps, Israel Defense Force Official(s) and/or principal investigator(s):
Tal Hasin, MD, Principal Investigator, Affiliation: Medical corps, Israel Defence Forces
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.
Results Treatment had no significant adverse effects. Ten smear-proven cases of TBRF were
identified and all belonged to the placebo group conferring a 100% efficacy of treatment. All
positive cases had identifiable tick bite marks. PCR was negative upon recruitment for all
subjects and positive in all subjects with fever and a positive smear. Seroconversion was
detected in 8 of 9 cases of TBRF. PCR and serology were negative in all the other study
groups.
Conclusions Prophylactic treatment with doxycycline is safe and efficacious in preventing
TBRF after suspected exposure in a high-risk environment. PCR for Borrelia GlpQ and serology
may assist the diagnosis of disease in the acute phase but not the detection of infection
during the incubation period.
Clinical Details
Official title: Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Israel Defence Forces, Tel Hashomer, Israel
Additional Information
Related 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.
Starting date: April 2002
Ending date: April 2003
Last updated: November 29, 2006
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