Status:
RECRUITING
Rickettsia Clearance Study
Lead Sponsor:
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit
Collaborating Sponsors:
Mahidol Oxford Tropical Medicine Research Unit
Conditions:
Infectious Disease
Therapeutics
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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, re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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:
- 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)
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05972772
Start Date
November 1 2024
End Date
August 31 2026
Last Update
December 27 2024
Active Locations (2)
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1
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
Vientiane, Vientaine, Laos, 0103
2
Vientiane Provincial Hospital
Vientiane Province, Vientiane Province, Laos