NCT06045481

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Aug 2024

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Aug 2024Oct 2027

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

March 13, 2024

Status Verified

May 1, 2023

Enrollment Period

2.2 years

First QC Date

September 13, 2023

Last Update Submit

March 12, 2024

Conditions

Relapsing Fever, Tick-Borne

Keywords

Tick-borne Diseasesdoxycyclinesoldiersisrael defense forces medical corps

Outcome Measures

Primary Outcomes (1)

  • Preventing Tick borne recurrent fever

    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

    From enrollment to the end of treatment and follow up at 3 weeks

Secondary Outcomes (1)

  • Side effects

    From enrollment to the end of treatment and follow up at 3 weeks

Study Arms (2)

Single Dose of 200mg doxycycline

EXPERIMENTAL

Treatment of a single dose of 200mg doxycycline

Drug: administration of single dose of doxycycline

Standard treatment of 5 days doxycycline (200mg at 1st day followed by 4 days of 100mg)

NO INTERVENTION

Treatment of 5 days doxycycline (200mg at 1st day followed by 4 days of 100mg)

Interventions

administration of single dose of doxycyclineDRUG

Postexposure prophylaxis with Single Dose doxycycline

Single Dose of 200mg doxycycline

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Israel Air Force flight course cadets.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Relapsing FeverTick-Borne Diseases

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Borrelia InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Barak Gordon, MD

    Israel defense forces medical corps

    STUDY DIRECTOR

Central Study Contacts

Mor Rittblat, MD

CONTACT

0528782526Rittblat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

August 1, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2027

Last Updated

March 13, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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