Tick-Bite; FeverFATBNCT03932448
Fever After Tick Bite Study
An observational study of Tick-Bite; Fever and Tick Fever, run by Göteborg University at 1 site in Sweden.
Trial summary
The proposed study is a collaboration between Microbiology, SU/Sahlgrenska and the Infectious Diseases clinic at SU/Östra as well as several Infectious Diseases clinics throughout Sweden aiming at improving microbiological diagnostic assays regarding the early identification of tick-borne microorganisms (including as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tick-Bite; Fever, Tick Fever, Tick-Borne Diseases
- What is being tested?
- The proposed study is not interventional.
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 15 May 2019to 4 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women ≥18 years old with documented or a medical history of fever (≥38°C) within 2 weeks after a tick bite.
Who may be able to join
- Written informed consent
- Male and female patients ≥18 years of age
- Medical history of tick bite within past 2 weeks
- Documented or medical history of fever (≥38°C) within past 2 weeks
Who cannot join
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Presence of urinary tract symptoms
- Presence of non-tick related, infectious agent causing fever, e.g. a respiratory virus
- Presence of other medical, non-infectious cause of fever
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fever After Tick Bite (FATB) Study; Determining the Etiology of Tick-Borne Human Infections in Northern Europe
The proposed study is a collaboration between Microbiology, SU/Sahlgrenska and the Infectious Diseases clinic at SU/Östra as well as several Infectious Diseases clinics throughout Sweden aiming at improving microbiological diagnostic assays regarding the early identification of tick-borne microorganisms (including as of yet unidentified pathogens) capable of causing human disease using modern diagnostic tools.
At the initial study visit (day 0) plasma, serum, urine, saliva, and PBMCs (and tick, if available) will be collected from patients developing fever within two weeks after a tick bite. Additional follow-up samples will be obtained after 9 and 30 days as well as after 6 months. The initial samples will be analyzed using (a) directed multiplex PCR analysis for Tick-Borne Encephalitis (TBE), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella, Tularemia, and Babesiosis in plasma, whole blood and urine, (b) conventional IgM and IgG serology for TBE, (c) "Next Generation Sequencing" (NGS) for the detection of bacterial 16s rRNA as well as unknown viruses, (d) potential biomarkers, and (e) host genetic factors. Among patients where initial sampling indicates the presence of a potential pathogen or in patients developing neurological symptoms, a lumbar puncture will be performed and CSF will be further analyzed. Samples will also be evaluated regarding potential microbiological factors predisposing for severity of infection.
The primary objective of the study is to improve diagnostic tools in the initial early phase of infections caused by tick-borne pathogens, especially TBE prior to the affliction of the central nervous system, and to attempt to identify which factors impact the course of infection as it is believed that approximately 75% of infected individuals resolve their infection in this first phase whereas others develop meningoencephalitis with significant subsequent neurological sequelae. Secondary objectives of the study include investigating for the presence of and treating other tick-borne pathogens, setting the stage for coming clinical trials evaluating novel anti-viral therapies for TBE.
- Being tested
- The proposed study is not interventional.
- Medical subject headings
- Tick Bites, Fever, Anaplasmosis, Tick-Borne Diseases, Encephalitis, Tick-Borne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The proposed study is not interventional.Other
The proposed study is not interventional. However, if a treatable microorganism is detected, e.g. Borrelia or Anaplasma, suitable therapy, e.g. doxycycline, will be in initiated if appropriate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiology of fever (≥38°C) developing within 2 weeks after a tick bite.
Number of participants with detectable Tick-Borne Encephalitis Virus (TBEV), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella burnetii, Tularemia, and/or Babesia infections.
Measured: Up to two weeks after the tick bite.
Proportion of subjects developing neurological symptoms after a tick bite.
The proportion of subjects developing neurological symptoms in each of the following etiological categories: Tick-Borne Encephalitis Virus (TBEV), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella burnetii, Tularemia, and/or Babesia.
Measured: Up to six months after the tick bite.
Proportion of subjects developing other serious, non-neurological symptoms or disease after a tick bite.
The proportion of subjects developing other serious, non-neurological symptoms or disease in each of the following etiological categories: Tick-Borne Encephalitis Virus (TBEV), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella burnetii, Tularemia, and/or Babesia.
Measured: Up to six months after the tick bite.
Secondary outcomes (24)
Impact of body mass index (BMI) of subjects on the risk of development of neurological symptoms.
Evaluation of body mass index (weight and height will be combined to report BMI in kg/m2) of subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Impact of waist circumference of subjects on the risk of development of neurological symptoms.
Evaluation of waist circumference (measured in cm) of subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Impact of gender of subjects on the risk of development of neurological symptoms.
Evaluation of gender (male vs. female) of subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Impact of age of subjects on the risk of development of neurological symptoms.
Evaluation of age (measured in years) of subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Impact of body mass index of subjects developing other serious, non-neurological symptoms or disease.
Evaluation of body mass index (weight and height will be combined to report BMI in kg/m2) of subjects developing vs. not developing other serious, non-neurological symptoms or disease.
Measured: Up to six months after the tick bite.
Impact of waist circumference of subjects developing other serious, non-neurological symptoms or disease.
Evaluation of waist circumference (measured in cm) of subjects developing vs. not developing other serious, non-neurological symptoms or disease.
Measured: Up to six months after the tick bite.
Impact of gender of subjects developing other serious, non-neurological symptoms or disease.
Evaluation of gender (male vs. female) of subjects developing vs. not developing other serious, non-neurological symptoms or disease.
Measured: Up to six months after the tick bite.
Impact of age of subjects developing other serious, non-neurological symptoms or disease.
Evaluation of age (measured in years) of subjects developing vs. not developing other serious, non-neurological symptoms or disease.
Measured: Up to six months after the tick bite.
Prospective evaluation of the utility of Next Generation Sequencing (NGS) for the detection of unknown viruses and of bacterial 16s rRNA vs. directed Multiplex PCR
Number of participants with Tick-Borne Encephalitis Virus (TBEV), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella burnetii, Tularemia, and/or Babesia infections as detected using Next Generation Sequencing (NGS) in comparison to Multiplex Polymerase Chain Reaction (Multiplex PCR).
Measured: Up to 30 days after the tick bite.
Prospective evaluation of the specificity and sensitivity of TBEV-RNA and TBE IgM serology in the early phase of infection, i.e. up to 30 days after the tick bite.
Comparison of the number of subjects correctly identified as being infected with TBEV by means of analysis of TBEV-RNA vs. TBE IgM serology in the early phase of infection, i.e. up to 30 days after the tick bite.
Measured: Up to 30 days after the tick bite.
Prospective evaluation of the specificity and sensitivity of TBEV-RNA in urine vs. plasma/whole blood in the early phase of TBE infection, i.e. up to 30 days after the tick bite.
Comparison of the number of subjects correctly identified as being infected with TBEV by means of analysis of TBEV-RNA in urine vs. plasma/whole blood in the early phase of TBE infection, i.e. up to 30 days after the tick bite.
Measured: Up to 30 days after the tick bite.
Prospective evaluation of the specificity and sensitivity of PCR for Borrelia DNA in plasma/serum as well as Borrelia IgM serology in the early phase of infection, i.e. up to 30 days after the tick bite.
Comparison the number of subjects correctly identified as being infected with Borrelia by means of analysis of PCR for Borrelia DNA in plasma/serum as well as Borrelia IgM and IgG serology in the early phase of infection, i.e. up to 30 days after the tick bite.
Measured: Up to 30 days after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of plasma concentrations of the neurological markers NFL in relation to the likelihood of developing neurological symptoms.
Comparison of plasma concentrations of the neurological marker NFL will be evaluated among subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of plasma concentrations of the neurological marker T-tau in relation to the likelihood of developing neurological symptoms.
Comparison of plasma concentrations of the neurological marker T-tau will be evaluated among subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of plasma concentrations of the neurological marker GFAp in relation to the likelihood of developing neurological symptoms.
Comparison of plasma concentrations of neurological marker GFAp will be evaluated among subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of plasma concentrations of IP-10 (aka CXCL10) in relation to the likelihood of developing neurological symptoms.
Comparison of plasma concentrations of IP-10 (aka CXCL10) will be evaluated among subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of 25-hydroxy vitamin D (25(OH)D) concentrations in relation to the likelihood of developing neurological symptoms.
Comparison of plasma concentrations of 25-hydroxy vitamin D (25(OH)D) will be evaluated among subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Prospective evaluation of peripheral blood mononuclear cells (PBMCs) analyzed by FACS, in relation to the likelihood of developing neurological symptoms.
Comparison of the proportion of CD56 negative NK, CD4+ CD38+, CD8+ CD38+, CD8+CD16+, Foxp3+, and pDC (CD303+) cells analyzed by FACS will be evaluated among subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Prospective evaluation of the impact of host genetic polymorphisms in the IFNL4 gene in relation to the likelihood of developing neurological symptoms.
Proportion of subjects with genetic polymorphisms in the IFNL4 gene evaluated among subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Prospective evaluation of the impact of host genetic polymorphisms in the ITPA gene in relation to the likelihood of developing neurological symptoms.
Proportion of subjects with genetic polymorphisms in the ITPA gene evaluated among subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Prospective evaluation of the impact of prior vaccination against TBE on frequency and outcome of TBEV infection.
Comparison of subjects with vs. without prior vaccination against TBE on frequency and outcome of TBEV infection.
Measured: From time of prior vaccination until six months after the tick bite.
Prospective evaluation of the impact of prior vaccination against Yellow Fever on frequency and outcome of TBEV infection.
Comparison of subjects with vs. without prior vaccination against Yellow Fever on frequency and outcome of TBEV infection.
Measured: From time of prior vaccination until six months after the tick bite.
Prospective evaluation of the impact of prior vaccination against Japanese Encephalitis on frequency and outcome of TBEV infection.
Comparison of subjects with vs. without prior vaccination against Japanese Encephalitis on frequency and outcome of TBEV infection.
Measured: From time of prior vaccination until six months after the tick bite.
Prospective evaluation of the association between presence or absence of immunosuppression in relation to the likelihood of developing neurological symptoms.
The proportion of subjects with vs. without immunosuppression will be evaluated among subjects developing vs. not developing neurological symptoms.
Measured: Up to six months after the tick bite.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start15 May 2019
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Why it stopped: Enrollment in the study was rendered unfeasible due to restrictions and disruptions caused by the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tick-Bite; FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Martin Lagging, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932448
- Sponsor's protocol ID
- FATB Study Group
- Acronym
- FATB
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2019
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fever After Tick Bite (FATB) Study; Determining the Etiology of Tick-Borne Human Infections in Northern Europe
- ClinicalTrials.gov ID
- NCT03932448
- Acronym / sponsor ID
- FATB / FATB Study Group
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Enrollment in the study was rendered unfeasible due to restrictions and disruptions caused by the COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Vastra Gotaland Region
- Study start
- 15 May 2019 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a collaboration between Microbiology, SU/Sahlgrenska and the Infectious Diseases clinic at SU/Östra as well as several Infectious Diseases clinics throughout Sweden aiming at improving microbiological diagnostic assays regarding the early identification of tick-borne microorganisms (including as of yet unidentified pathogens) capable of causing human disease using modern diagnostic tools.
At the initial study visit (day 0) plasma, serum, urine, saliva, and PBMCs (and tick, if available) will be collected from patients developing fever within two weeks after a tick bite. Additional follow-up samples will be obtained after 9 and 30 days as well as after 6 months. The initial samples will be analyzed using (a) directed multiplex PCR analysis for Tick-Borne Encephalitis (TBE), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella, Tularemia, and Babesiosis in plasma, whole blood and urine, (b) conventional IgM and IgG serology for TBE, (c) "Next Generation Sequencing" (NGS) for the detection of bacterial 16s rRNA as well as unknown viruses, (d) potential biomarkers, and (e) host genetic factors. Among patients where initial sampling indicates the presence of a potential pathogen or in patients developing neurological symptoms, a lumbar puncture will be performed and CSF will be further analyzed. Samples will also be evaluated regarding potential microbiological factors predisposing for severity of infection.
The primary objective of the study is to improve diagnostic tools in the initial early phase of infections caused by tick-borne pathogens, especially TBE prior to the affliction of the central nervous system, and to attempt to identify which factors impact the course of infection as it is believed that approximately 75% of infected individuals resolve their infection in this first phase whereas others develop meningoencephalitis with significant subsequent neurological sequelae. Secondary objectives of the study include investigating for the presence of and treating other tick-borne pathogens, setting the stage for coming clinical trials evaluating novel anti-viral therapies for TBE.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women ≥18 years old with documented or a medical history of fever (≥38°C) within 2 weeks after a tick bite.
Key inclusion criteria (4 listed)
- Written informed consent
- Male and female patients ≥18 years of age
- Medical history of tick bite within past 2 weeks
- Documented or medical history of fever (≥38°C) within past 2 weeks
Key exclusion criteria (4 listed)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Presence of urinary tract symptoms
- Presence of non-tick related, infectious agent causing fever, e.g. a respiratory virus
- Presence of other medical, non-infectious cause of fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The proposed study is not interventional.The proposed study is not interventional. However, if a treatable microorganism is detected, e.g. Borrelia or Anaplasma, suitable therapy, e.g. doxycycline, will be in initiated if appropriate. | Other | – |
Primary outcome
Etiology of fever (≥38°C) developing within 2 weeks after a tick bite.
Time frame: Up to two weeks after the tick bite.
Number of participants with detectable Tick-Borne Encephalitis Virus (TBEV), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella burnetii, Tularemia, and/or Babesia infections.
Proportion of subjects developing neurological symptoms after a tick bite.
Time frame: Up to six months after the tick bite.
The proportion of subjects developing neurological symptoms in each of the following etiological categories: Tick-Borne Encephalitis Virus (TBEV), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella burnetii, Tularemia, and/or Babesia.
Proportion of subjects developing other serious, non-neurological symptoms or disease after a tick bite.
Time frame: Up to six months after the tick bite.
The proportion of subjects developing other serious, non-neurological symptoms or disease in each of the following etiological categories: Tick-Borne Encephalitis Virus (TBEV), Borrelia, Anaplasma, Neoerlichia, Rickettsia, Coxiella burnetii, Tularemia, and/or Babesia.
24 secondary outcomes
Impact of body mass index (BMI) of subjects on the risk of development of neurological symptoms.
Time frame: Up to six months after the tick bite.
Impact of waist circumference of subjects on the risk of development of neurological symptoms.
Time frame: Up to six months after the tick bite.
Impact of gender of subjects on the risk of development of neurological symptoms.
Time frame: Up to six months after the tick bite.
Impact of age of subjects on the risk of development of neurological symptoms.
Time frame: Up to six months after the tick bite.
Impact of body mass index of subjects developing other serious, non-neurological symptoms or disease.
Time frame: Up to six months after the tick bite.
Impact of waist circumference of subjects developing other serious, non-neurological symptoms or disease.
Time frame: Up to six months after the tick bite.
Impact of gender of subjects developing other serious, non-neurological symptoms or disease.
Time frame: Up to six months after the tick bite.
Impact of age of subjects developing other serious, non-neurological symptoms or disease.
Time frame: Up to six months after the tick bite.
Prospective evaluation of the utility of Next Generation Sequencing (NGS) for the detection of unknown viruses and of bacterial 16s rRNA vs. directed Multiplex PCR
Time frame: Up to 30 days after the tick bite.
Prospective evaluation of the specificity and sensitivity of TBEV-RNA and TBE IgM serology in the early phase of infection, i.e. up to 30 days after the tick bite.
Time frame: Up to 30 days after the tick bite.
Prospective evaluation of the specificity and sensitivity of TBEV-RNA in urine vs. plasma/whole blood in the early phase of TBE infection, i.e. up to 30 days after the tick bite.
Time frame: Up to 30 days after the tick bite.
Prospective evaluation of the specificity and sensitivity of PCR for Borrelia DNA in plasma/serum as well as Borrelia IgM serology in the early phase of infection, i.e. up to 30 days after the tick bite.
Time frame: Up to 30 days after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of plasma concentrations of the neurological markers NFL in relation to the likelihood of developing neurological symptoms.
Time frame: Up to six months after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of plasma concentrations of the neurological marker T-tau in relation to the likelihood of developing neurological symptoms.
Time frame: Up to six months after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of plasma concentrations of the neurological marker GFAp in relation to the likelihood of developing neurological symptoms.
Time frame: Up to six months after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of plasma concentrations of IP-10 (aka CXCL10) in relation to the likelihood of developing neurological symptoms.
Time frame: Up to six months after the tick bite.
Prospective evaluation of the specificity and sensitivity of early evaluation of 25-hydroxy vitamin D (25(OH)D) concentrations in relation to the likelihood of developing neurological symptoms.
Time frame: Up to six months after the tick bite.
Prospective evaluation of peripheral blood mononuclear cells (PBMCs) analyzed by FACS, in relation to the likelihood of developing neurological symptoms.
Time frame: Up to six months after the tick bite.
Prospective evaluation of the impact of host genetic polymorphisms in the IFNL4 gene in relation to the likelihood of developing neurological symptoms.
Time frame: Up to six months after the tick bite.
Prospective evaluation of the impact of host genetic polymorphisms in the ITPA gene in relation to the likelihood of developing neurological symptoms.
Time frame: Up to six months after the tick bite.
Prospective evaluation of the impact of prior vaccination against TBE on frequency and outcome of TBEV infection.
Time frame: From time of prior vaccination until six months after the tick bite.
Prospective evaluation of the impact of prior vaccination against Yellow Fever on frequency and outcome of TBEV infection.
Time frame: From time of prior vaccination until six months after the tick bite.
Prospective evaluation of the impact of prior vaccination against Japanese Encephalitis on frequency and outcome of TBEV infection.
Time frame: From time of prior vaccination until six months after the tick bite.
Prospective evaluation of the association between presence or absence of immunosuppression in relation to the likelihood of developing neurological symptoms.
Time frame: Up to six months after the tick bite.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Lagging, MD, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tick-Bite; Fever and Tick Fever, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Etiology of fever (≥38°C) developing within 2 weeks after a tick bite. (time frame: Up to two weeks after the tick bite.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.