Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06045481 |
| Other study ID # |
2358-2023 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2024 |
| Est. completion date |
October 31, 2027 |
Study information
| Verified date |
May 2023 |
| Source |
Medical Corps, Israel Defense Force |
| Contact |
Mor Rittblat, MD |
| Phone |
0528782526 |
| Email |
Rittblat[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
1. In accordance with the guidelines of the Institutional Review Board (IRB), following the
completion of the field exercise series, all participating soldiers, both those who
actively engaged in the experiment and those who did not, will undergo examination for
signs of insect bites.
2. After the medical examination, a treating physician (who is not one of the researchers
involved in the study) will determine whether there are signs requiring doxycycline
antibiotic treatment for soldiers who participated in the field exercise (regardless of
their participation in the research). According to the IRB and IRB guidelines, an Air
Force pilot cadet will receive antibiotic treatment if any of the following conditions
exist on their body: insect bites, suspicious bites resembling tick bites, or similar
symptoms on the spouse of the participant in the exercise.
3. Prophylactic treatment following exposure, whether following a standard doxycycline
protocol or a single-dose experimental treatment of 200 mg with a placebo pill, will be
administered with instructions on how to take the medication to minimize the risk of
side effects, particularly pill esophagitis ("take the medication with plenty of water
and remain upright (standing/sitting) for at least half an hour after taking the pill").
4. In cases where it is determined that there is no need for prophylactic treatment,
participants will be monitored as an observational control group, distinct from the two
experimental arms. In cases where it is decided that treatment is warranted, different
approaches will be taken depending on whether the participant is involved in the
experiment or not:
- Non-participating Air Force pilots cadets will be treated according to the standard
doxycycline protocol as per IRB guidelines. They will receive doxycycline from the
medical facility as prescribed by a physician.
- Air Force pilots cadets participating in the experiment who are recommended or
whose spouses are recommended to receive treatment will receive a packet of pills
containing the standard dosage or the experimental treatment, depending on
randomization that will occur prior to the distribution of treatment packets. These
packets will be provided in advance by the Medical Corps and will be labeled
differently according to the dosage. Specifically, a packet containing 6
doxycycline pills at a dosage of 100 mg will be labeled differently from a packet
containing 6 pills, with only 2 of them being 100 mg doxycycline, and the rest
being placebos. The first two pills containing the active drug will be labeled
separately. Only Dr. Yoni Yosef, one of the researcher, will have access to
information indicating which label represents the standard dosage and which label
represents the experimental dosage. In other words, the physician who examines the
soldier and other researchers and study participants will not be exposed to
information about which treatment arm the soldier was assigned to, in order to
maintain double-blinding. Consequently, a Case Report Form (CRF) documenting the
medical examination, treatment decision, and explanation that the soldier
participated in the experiment and received either standard doxycycline treatment
or a single-dose combination with placebo will be generated.
Additionally, if a soldier develops a fever within two weeks after participating in the
field exercise, it may be indicative of a relapsing fever that was partially treated. In
such cases, the soldier will be referred to the Ichilov medical center emergency
department for evaluation, with coordination with the principal investigator or the
study coordinator, in an organized manner. Furthermore, medical oversight by the Medical
Corps' specialist will be provided in cases where an Air Force pilot cadets who did not
show any signs of insect bites, but based on a physician's assessment, it is decided
that their spouse should receive treatment. This oversight is not dependent on the
participation of the Air Force pilot cadets or their spouse in the field exercise or the
type of treatment given.
5. Three weeks after the completion of the field exercise series, all participants who
attended the field exercise and agreed to participate in the experiment will undergo
clinical follow-up, irrespective of whether they required antibiotic treatment. Those
not requiring antibiotic treatment will be assessed by a medical officer regarding their
medical condition, including signs of relapsing fever and fever. Those who required
antibiotic treatment will also be assessed by a medical officer, including an evaluation
of signs of relapsing fever, fever, their response to treatment, and follow-up questions
regarding the administration of treatment. At this stage, participants in the study, as
well as the physicians treating them, will not be aware of which treatment arm they
belong to.
Should participants develop symptoms consistent with relapsing fever or exhibit
suspicion of this condition, they will be referred to a medical evaluation in the
Ichilov medical center emergency department, in coordination with the principal
investigator and the study coordinator. There, blood tests will be conducted, including
thick smear for the diagnosis of relapsing fever, along with additional tests as
necessary and at the discretion of the hospital physician. The principal investigator
will be responsible for referring the soldier to Malram for evaluation, with
coordination with the senior hospital epidemiologist.
6. Three weeks after the completion of the field exercise series and the decision regarding
treatment, participants in the experiment will complete a digital survey. This survey
will be sent to their personal phones to assess side effects of medical treatment or the
presence of suspicious symptoms of relapsing fever that were not reported to the medical
facility and were not mentioned during the private interview one week after the end of
the series. The survey will be filled out using the Microsoft Forms platform, with
participant identification based on a serial number provided at the time of informed
consent. In other words, there will be no documentation of ID numbers or other
identifying information in the generated digital file. The survey will be completed
using an online platform such as google or microsoft forms, with participant
identification based on a serial number provided at the time of informed consent. Again,
there will be no documentation of ID numbers or other identifying information in the
generated digital file.
7. Upon completion of the digital survey by all participants of the experiment, the
envelopes will be opened, and the researchers will update the electronic medical record
with the specific treatment arm to which the participants belonged. Additionally, the
study coordinator will inform the battalion's physician in a personalized manner.
8. Each series will be independent of the others, and the same process will be conducted
for both series. Prior to each series, participants will sign an informed consent form,
and a detailed explanation of all stages will be provided.
Regenerate
