Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever
This study has been completed.
Sponsor:
Medical Corps, Israel Defense Force
Information provided by:
Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT00237016
First received: October 7, 2005
Last updated: October 23, 2008
Last verified: April 2003
| Tracking Information | |||||
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| First Received Date ICMJE | October 7, 2005 | ||||
| Last Updated Date | October 23, 2008 | ||||
| Start Date ICMJE | April 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00237016 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever | ||||
| Official Title ICMJE | Post Exposure Treatment With Doxycycline for the Prevention of Relapsing Fever | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: doxycycline treatment | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 140 | ||||
| Completion Date | April 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00237016 | ||||
| Other Study ID Numbers ICMJE | RF1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Medical Corps, Israel Defense Force | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical Corps, Israel Defense Force | ||||
| Verification Date | April 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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