Postexposure Prophylaxis With Single Dose Doxycycline for the Prevention of Tick-borne Relapsing Fever
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ClinicalTrials.gov Identifier: NCT06045481 |
Recruitment Status :
Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : March 13, 2024
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The goal of this clinical trial is to compare standard treatment (5 days of doxycycline) vs single dose doxycycline for the prevention of tick-borne relapsing fever in soldiers who found bite marks on their bodies after an activity that includes contact with the ground or staying at a site suspected of being infected with ticks. The main question[s] it aims to answer are:
- Testing whether preventive treatment with a single dose of doxylin at a dose of 200 mg is effective in preventing recurrent fever, and if so, at what rate
- Checking the profile and rate of side effects in each one of the proposed treatment protocols Participants will be treated with standard treatment (5 days of doxycycline) or single dose doxycycline.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsing Fever, Tick-Borne | Drug: administration of single dose of doxycycline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 526 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Postexposure Prophylaxis With Single Dose Doxycycline for the Prevention of Tick-borne Relapsing Fever |
Estimated Study Start Date : | August 1, 2024 |
Estimated Primary Completion Date : | October 31, 2026 |
Estimated Study Completion Date : | October 31, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Single Dose of 200mg doxycycline
Treatment of a single dose of 200mg doxycycline
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Drug: administration of single dose of doxycycline
Postexposure prophylaxis with Single Dose doxycycline |
No Intervention: Standard treatment of 5 days doxycycline (200mg at 1st day followed by 4 days of 100mg)
Treatment of 5 days doxycycline (200mg at 1st day followed by 4 days of 100mg)
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- Preventing Tick borne recurrent fever [ Time Frame: From enrollment to the end of treatment and follow up at 3 weeks ]Examining whether preventive treatment with a single dose of doxycycline at a dose of 200 mg is effective in preventing Tick borne recurrent fever compared to treatment with the standard protocol lasting 5 days
- Side effects [ Time Frame: From enrollment to the end of treatment and follow up at 3 weeks ]Checking the profile and rate of side effects in each one of the proposed treatment protocols
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Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Israel Air Force flight course cadets.
Exclusion Criteria:
- Known sensitivity or allergy to doxycycline
- Fever in the three weeks preceding the performance of the field series
- Suspicion of the Tick borne disease with recurrent fever three weeks before performing the
- Incompletion of the field series
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045481
Contact: Mor Rittblat, MD | 0528782526 | Rittblat@gmail.com |
Study Director: | Barak Gordon, MD | Israel defense forces medical corps |
Responsible Party: | Medical Corps, Israel Defense Force |
ClinicalTrials.gov Identifier: | NCT06045481 |
Other Study ID Numbers: |
2358-2023 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | March 13, 2024 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in Tick-borne Relapsing Fever. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 96 months. Extensions will be considered on a case-by-case basis. |
Access Criteria: | Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact mor.rittblat@mail.huji.ac.il |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tick-borne Diseases doxycycline soldiers israel defense forces medical corps |
Relapsing Fever Fever Body Temperature Changes Borrelia Infections Spirochaetales Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Tick-Borne Diseases Vector Borne Diseases Doxycycline Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |