Infectious DiseasePhase 2/3RiCSNCT05972772
Rickettsia Clearance Study
A Phase 2/3 study testing Doxycyclin and Azithromycin in people with Infectious Disease and Therapeutics, run by Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit at 2 sites in Laos.
Trial summary
Murine typhus is a disease caused by Rickettisa typhi, an obligate intracellular bacterium transmitted by rodent fleas. The disease has a worldwide distribution; however the true burden is unknown, related to its non-specific presentation and lack of access to diagnosis in many regions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease, Therapeutics
- What is being tested?
- Doxycyclin and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesLaos
- Study dates
- 1 Nov 2024to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above or equal 18 years
- Able to take oral medication
- Rapid test positive for murine typhus or scrub typhus
- Agrees to stay in hospital for at least 36 hours and to attend for scheduled follow up visits
- Written informed consent to participate in the study
- A negative urinary pregnancy test for all women of child-bearing age
Who cannot join
- Pregnancy or breast feeding
- Previous allergic reaction to doxycycline or azithromycin
- Received more than one dose of chloramphenicol, doxycycline, tetracycline, fluoroquinolones, rifampicin or azithromycin during this hospital admission or more than one dose of any of these drugs in the week before admission
- Contraindication to doxycycline: severe hepatic impairment, known SLE
- Contraindication to azithromycin: sever hepatic impairment
- Severe typhus defined as the presence of one or more of the following:
Show all 14Show fewer
- Reduced level of consciousness
- Clinical jaundice
- Shock (BP systolic <80 mmHg)
- Unable to take oral medication
- Radiological evidence of pneumonia
- Clinical evidence for meningitis/encephalitis or the need of LP
- Alternative diagnosis confirmed that explains the presenting symptoms
- Any other syndrome which in the opinion of the admitting doctor constitutes severe typhus (reason must be stated)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laos2 sites, 2 recruiting
- Recruiting
Vientiane Provincial Hospital
Muang Phon-Hong, Vientiane Province
Elizabeth Ashley, +85621250752, elizabeth.ashley@tropmedres.ac
- Recruiting
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
Vientiane, Vientaine, 0103
Professor Elizabeth Ashley, +85621250752, elizabeth.ashley@tropmedes.ac
About this study
Official title: A Pharmacokinetic-pharmacodynamic Study of Early Rickettsia Clearance in Murine Typhus or Scrub Typhus Patients Treated With Doxycycline or Azithromycin
Murine typhus is a disease caused by Rickettisa typhi, an obligate intracellular bacterium transmitted by rodent fleas. The disease has a worldwide distribution; however the true burden is unknown, related to its non-specific presentation and lack of access to diagnosis in many regions. A systematic review of untreated murine typhus based on observational studies of a total of 239 patients has estimated the mortality associated with the disease at between 0.4% and 3.6%.
Scrub typhus is caused by Orientia tsutsugamushi and transmitted by the larval stage of chigger mites (Trombiculidae family). It has been estimated to affect at least one million people each year. A systematic review found varying reports of the mortality associated with untreated scrub typhus ranging from 0-70% (median 6%).
Polymerase chain reaction (PCR) based diagnosis of rickettsial infections is only available in one centre (Mahosot Hospital) in Vientiane. A number of hospitals use a variety of point-of-care antibody tests to diagnose rickettsial infections however many of these have not been validated and they are of uncertain sensitivity and specificity. In 2006 results of a two year prospective study of 427 patients presenting to Mahosot Hospital with a febrile illness and negative blood cultures showed that 115 (27%) patients had an acute rickettsial infection, confirmed by serological testing. Among these patients, 41 were diagnosed with murine typhus and 63 with scrub typhus. Antibacterial agents with activity against rickettsial pathogens include doxycycline, azithromycin, chloramphenicol and rifampicin. Azithromycin is often reserved for pregnant women or children below the age of 8 years due to lasting concerns after the tetracycline-associated staining of growing bones and teeth in the past. Evidence is accumulating that doxycycline is superior to azithromycin for the treatment of rickettsial disease. Clinical treatment failures have occurred following azithromycin treatment of murine typhus. The relationship between rickettsial bacteria load and both disease severity and response to treatment has not been characterised. Rickettsial concentrations in blood are generally low, of the order of 210 DNA copies/mL blood for R. typhi and 284 DNA copies/mL blood for O. tsutsugamushi. At present, there is no standard antibiotic susceptibility testing (AST) method for R. typhi and O. tsutsugamushi. The gold standard method for AST for Rickettsia pathogens is the plaque assay which determines minimal inhibitory concentration (MICs) from the smallest antimicrobial concentration inhibiting rickettsial plaque forming unit formation. This method is laborious and time consuming, taking approximately 14-16 days based on species to yield a result. Molecular detection methods are useful for diagnosing patients infected with rickettsial pathogens and has been applied for antibiotic susceptibility testing. Antibiotic susceptibility testing based on DNA synthesis inhibition detecting by quantitative PCR (qPCR) for O. tsutsugamushi clinical isolates has been reported. However, the relationship between antibiotic susceptibility profiles and treatment response has not been studied. There is a need to develop a reliable ex vivo method to characterize the treatment response and compare susceptibility of R. typhi and O. tsutsugamushi to different agents.
- Conditions
- Infectious Disease, Therapeutics
- Being tested
- Doxycyclin, Azithromycin
- Keywords
- Scrub Typhus, Typhus, Endemic Flea-Borne
- Medical subject headings
- Communicable Diseases, Scrub Typhus, Typhus, Endemic Flea-Borne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclinDrug
Also called vibramycin
100-mg film-coated tablets; Pfizer
AzithromycinDrug
Also called Zithromax
250-mg capsules; Pfizer
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | Doxycycline (Vibramycin, 100-mg film-coated tablets; Pfizer)) 200-mg loading dose, followed by 100 mg every 12 hours for 3 days. Receives: Drug: Doxycyclin |
| Azithromycin | Active comparator | Azithromycin (Zithromax, 250-mg capsules; Pfizer) with a 500-mg loading dose, followed by 250 mg every 24 hours for 2 days. This will be followed by three days of doxycycline at the dose in A. Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clearance of R. typhi or O. tsutsugamushi from peripheral blood of patients using serial qPCR measurement
Measure of clearance or R. typhi or O. tsutsugamushi DNA assessed by serial qPCR measurements on the blood from murine typhus patients treated with either doxycycline or azithromycin. Rickettsia clearance rate will be estimated from serial qPCR measurement in each patient. The clearance rate is the slope of the initial log linear decline in qPCR estimated bacteria densities
Measured: Within 72 hours after treatment
Secondary outcomes (12)
Area under the plasma concentration versus time curve (AUC) of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
AUC of doxycycline or azithromycin versus time from zero to infinity in the treatment of murine typhus and scrub typhus will be estimated using a modelling approach
Measured: Doxycycline: Based on plasma concentrations measure up to 96 hours after the last dose. Azithromycin: Based on plasma concentrations measure up to 2 weeks after the first dose.
Area under the intracellular concentration in the buffy coat versus time curve (AUC) of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
AUC of doxycycline or azithromycin versus time from zero to infinity in the treatment of murine typhus and scrub typhus will be estimated using a modelling approach
Measured: Doxycycline: Based on intracellular concentrations in the buffy coat measure up to 96 hours after the last dose. Azithromycin: Based on intracellular concentrations in Buffy coat measure up to 2 weeks after the first dose.
Peak plasma concentration (Cmax) of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Cmax of doxycycline or azithromycin versus time from zero to infinity in the treatment of murine typhus and scrub typhus will be estimated using a modelling approach
Measured: Doxycycline: Based on plasma concentrations measure up to 96 hours after the last dose. Azithromycin: Based on plasma concentrations measure up to 2 weeks after the first dose.
Peak of the intracellular concentration (Cmax) in the buffy coat of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Cmax of doxycycline or azithromycin versus time from zero to infinity in the treatment of murine typhus and scrub typhus will be estimated using a modelling approach
Measured: Doxycycline: Based on intracellular concentrations in the buffy coat measure up to 96 hours after the last dose. Azithromycin: Based on intracellular concentrations in the buffy coat measure up to 2 weeks after the first dose.
Time to peak plasma concentration (Tmax) of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Tmax of doxycycline or azithromycin versus time from zero to infinity in the treatment of murine typhus and scrub typhus will be estimated using a modelling approach
Measured: Doxycycline: Based on plasma concentrations measure up to 96 hours after the last dose. Azithromycin: Based on plasma concentrations measure up to 2 weeks after the first dose.
Time to peak of the intracellular concentration (Tmax) in the buffy coat of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Tmax of doxycycline or azithromycin versus time from zero to infinity in the treatment of murine typhus and scrub typhus will be estimated using a modelling approach
Measured: Doxycycline: Based on intracellular concentrations in the buffy coat measure up to 96 hours after the last dose. Azithromycin: Based on intracellular concentrations in the buffy coat measure up to 2 weeks after the first dose.
Time at doxycycline or azithromycin has lost half its maximum concentration (T1/2) for the treatment of murine typhus or scrub typhus
T1/2 of doxycycline or azithromycin versus time from zero to infinity in the treatment of murine typhus and scrub typhus will be estimated using a modelling approach
Measured: Doxycycline: Based on plasma concentrations measure up to 96 hours after the last dose. Azithromycin: Based on plasma concentrations measure up to 2 weeks after the first dose.
Time at doxycycline or azithromycin has lost half its maximum intracellular concentration (T1/2) for the treatment of murine typhus or scrub typhus
T1/2 of doxycycline or azithromycin versus time from zero to infinity in the treatment of murine typhus and scrub typhus will be estimated using a modelling approach
Measured: Doxycycline: Based on intracellular concentrations in the buffy coat measure up to 96 hours after the last dose. Azithromycin: Based on intracellular concentrations in the buffy coat measure up to 2 weeks after the first dose.
Fever clearance time in patients with scrub typhus or murine typhus treated with doxycycline or azithromycin
Fever clearance time is defined as the time in hours from onset of antibiotic treatment, to the first Axillary temperature recording less than or equal 37.5°C, which then remains less than or equal 37.5°C for 24 hours
Measured: First 7 days after treatment
Frequency of serious adverse events (SAEs) after treatment
SAEs will be defined using the Common Toxicity Criteria (v5.0) of the US National Cancer Institute
Measured: Day 0 to day 28
Evaluation the accuracy of the new brand RDT, Rickettsia IgG/IgM Combo (Lumiquick) compared to Scrub typhus Detect IgM Rapid System (Dipstick) (InBios)
Sensitivity and specificity of Rickettsia IgG/IgM Combo (Lumiquick) compared to Scrub typhus Detect IgM Rapid System (Dipstick) (InBios) will be compared
Measured: Day 0
Evaluation the accuracy of Rickettsia IgG/IgM Combo (Lumiquick) compared to a combined gold standard of PCR assays and serology (paired samples)
Sensitivity and specificity of RDT (Lumiquick) result will be compared to a combined gold standard of PCR assays and serology (paired serum)
Measured: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
- Investigators
- Weerawat Phuklia, PhD, Principal investigator, Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972772
- Sponsor's protocol ID
- 26-23
- Acronym
- RiCS
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With participant's consent, participant's data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with data repositories or other researchers to use in the future.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic-pharmacodynamic Study of Early Rickettsia Clearance in Murine Typhus or Scrub Typhus Patients Treated With Doxycycline or Azithromycin
- ClinicalTrials.gov ID
- NCT05972772
- Acronym / sponsor ID
- RiCS / 26-23
- Conditions
- Infectious Disease, Therapeutics
- Keywords
- Scrub Typhus, Typhus, Endemic Flea-Borne
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Lao-Oxford-Mahosot Hospital Wellcome Trust Research UnitUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Aug 2023 (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.
Murine typhus is a disease caused by Rickettisa typhi, an obligate intracellular bacterium transmitted by rodent fleas. The disease has a worldwide distribution; however the true burden is unknown, related to its non-specific presentation and lack of access to diagnosis in many regions. A systematic review of untreated murine typhus based on observational studies of a total of 239 patients has estimated the mortality associated with the disease at between 0.4% and 3.6%.
Scrub typhus is caused by Orientia tsutsugamushi and transmitted by the larval stage of chigger mites (Trombiculidae family). It has been estimated to affect at least one million people each year. A systematic review found varying reports of the mortality associated with untreated scrub typhus ranging from 0-70% (median 6%).
Polymerase chain reaction (PCR) based diagnosis of rickettsial infections is only available in one centre (Mahosot Hospital) in Vientiane. A number of hospitals use a variety of point-of-care antibody tests to diagnose rickettsial infections however many of these have not been validated and they are of uncertain sensitivity and specificity. In 2006 results of a two year prospective study of 427 patients presenting to Mahosot Hospital with a febrile illness and negative blood cultures showed that 115 (27%) patients had an acute rickettsial infection, confirmed by serological testing. Among these patients, 41 were diagnosed with murine typhus and 63 with scrub typhus. Antibacterial agents with activity against rickettsial pathogens include doxycycline, azithromycin, chloramphenicol and rifampicin. Azithromycin is often reserved for pregnant women or children below the age of 8 years due to lasting concerns after the tetracycline-associated staining of growing bones and teeth in the past. Evidence is accumulating that doxycycline is superior to azithromycin for the treatment of rickettsial disease. Clinical treatment failures have occurred following azithromycin treatment of murine typhus. The relationship between rickettsial bacteria load and both disease severity and response to treatment has not been characterised. Rickettsial concentrations in blood are generally low, of the order of 210 DNA copies/mL blood for R. typhi and 284 DNA copies/mL blood for O. tsutsugamushi. At present, there is no standard antibiotic susceptibility testing (AST) method for R. typhi and O. tsutsugamushi. The gold standard method for AST for Rickettsia pathogens is the plaque assay which determines minimal inhibitory concentration (MICs) from the smallest antimicrobial concentration inhibiting rickettsial plaque forming unit formation. This method is laborious and time consuming, taking approximately 14-16 days based on species to yield a result. Molecular detection methods are useful for diagnosing patients infected with rickettsial pathogens and has been applied for antibiotic susceptibility testing. Antibiotic susceptibility testing based on DNA synthesis inhibition detecting by quantitative PCR (qPCR) for O. tsutsugamushi clinical isolates has been reported. However, the relationship between antibiotic susceptibility profiles and treatment response has not been studied. There is a need to develop a reliable ex vivo method to characterize the treatment response and compare susceptibility of R. typhi and O. tsutsugamushi to different agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: DoxycyclinDoxycycline (Vibramycin, 100-mg film-coated tablets; Pfizer)) 200-mg loading dose, followed by 100 mg every 12 hours for 3 days. |
| Azithromycin | Active comparator | Drug: AzithromycinAzithromycin (Zithromax, 250-mg capsules; Pfizer) with a 500-mg loading dose, followed by 250 mg every 24 hours for 2 days. This will be followed by three days of doxycycline at the dose in A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above or equal 18 years
- Able to take oral medication
- Rapid test positive for murine typhus or scrub typhus
- Agrees to stay in hospital for at least 36 hours and to attend for scheduled follow up visits
- Written informed consent to participate in the study
Key exclusion criteria (14 listed)
- Pregnancy or breast feeding
- Previous allergic reaction to doxycycline or azithromycin
- Received more than one dose of chloramphenicol, doxycycline, tetracycline, fluoroquinolones, rifampicin or azithromycin during this hospital admission or more than one dose of any of these drugs in the week before admission
- Contraindication to doxycycline: severe hepatic impairment, known SLE
- Contraindication to azithromycin: sever hepatic impairment
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 |
|---|---|---|
| DoxycyclinAlso: vibramycin100-mg film-coated tablets; Pfizer | Drug | Doxycycline |
| AzithromycinAlso: Zithromax250-mg capsules; Pfizer | Drug | Azithromycin |
Primary outcome
Rate of clearance of R. typhi or O. tsutsugamushi from peripheral blood of patients using serial qPCR measurement
Time frame: Within 72 hours after treatment
Measure of clearance or R. typhi or O. tsutsugamushi DNA assessed by serial qPCR measurements on the blood from murine typhus patients treated with either doxycycline or azithromycin. Rickettsia clearance rate will be estimated from serial qPCR measurement in each patient. The clearance rate is the slope of the initial log linear decline in qPCR estimated bacteria densities
12 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Time frame: Doxycycline: Based on plasma concentrations measure up to 96 hours after the last dose. Azithromycin: Based on plasma concentrations measure up to 2 weeks after the first dose.
Area under the intracellular concentration in the buffy coat versus time curve (AUC) of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Time frame: Doxycycline: Based on intracellular concentrations in the buffy coat measure up to 96 hours after the last dose. Azithromycin: Based on intracellular concentrations in Buffy coat measure up to 2 weeks after the first dose.
Peak plasma concentration (Cmax) of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Time frame: Doxycycline: Based on plasma concentrations measure up to 96 hours after the last dose. Azithromycin: Based on plasma concentrations measure up to 2 weeks after the first dose.
Peak of the intracellular concentration (Cmax) in the buffy coat of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Time frame: Doxycycline: Based on intracellular concentrations in the buffy coat measure up to 96 hours after the last dose. Azithromycin: Based on intracellular concentrations in the buffy coat measure up to 2 weeks after the first dose.
Time to peak plasma concentration (Tmax) of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Time frame: Doxycycline: Based on plasma concentrations measure up to 96 hours after the last dose. Azithromycin: Based on plasma concentrations measure up to 2 weeks after the first dose.
Time to peak of the intracellular concentration (Tmax) in the buffy coat of doxycycline or azithromycin for the treatment of murine typhus or scrub typhus
Time frame: Doxycycline: Based on intracellular concentrations in the buffy coat measure up to 96 hours after the last dose. Azithromycin: Based on intracellular concentrations in the buffy coat measure up to 2 weeks after the first dose.
Time at doxycycline or azithromycin has lost half its maximum concentration (T1/2) for the treatment of murine typhus or scrub typhus
Time frame: Doxycycline: Based on plasma concentrations measure up to 96 hours after the last dose. Azithromycin: Based on plasma concentrations measure up to 2 weeks after the first dose.
Time at doxycycline or azithromycin has lost half its maximum intracellular concentration (T1/2) for the treatment of murine typhus or scrub typhus
Time frame: Doxycycline: Based on intracellular concentrations in the buffy coat measure up to 96 hours after the last dose. Azithromycin: Based on intracellular concentrations in the buffy coat measure up to 2 weeks after the first dose.
Fever clearance time in patients with scrub typhus or murine typhus treated with doxycycline or azithromycin
Time frame: First 7 days after treatment
Frequency of serious adverse events (SAEs) after treatment
Time frame: Day 0 to day 28
Evaluation the accuracy of the new brand RDT, Rickettsia IgG/IgM Combo (Lumiquick) compared to Scrub typhus Detect IgM Rapid System (Dipstick) (InBios)
Time frame: Day 0
Evaluation the accuracy of Rickettsia IgG/IgM Combo (Lumiquick) compared to a combined gold standard of PCR assays and serology (paired samples)
Time frame: Day 0 and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. With participant's consent, participant's data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with data repositories or other researchers to use in the future.
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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.
Weerawat Phuklia, PhD principal investigator
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Doxycyclin and Azithromycin in people with Infectious Disease and Therapeutics, run by Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit at 2 sites in Laos.
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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Laos. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weerawat Phuklia, PhD (+8562056581365, weerawat@tropmedres.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clearance of R. typhi or O. tsutsugamushi from peripheral blood of patients using serial qPCR measurement (time frame: Within 72 hours after treatment). 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 13 Oct 2026.