RiCSA Pharmacokinetic-pharmacodynamic Study of Early Rickettsia Clearance in Murine Typhus or Scrub Typhus Patients Treated with Doxycycline or Azithromycin
Doxycyclin
+ Azithromycin
Vector Borne Diseases+10
+ Bacterial Infections and Mycoses
+ Bacterial Infections
Treatment Study
Summary
Study start date: November 1, 2024
Actual date on which the first participant was enrolled.The study investigates how well two antibiotics, doxycycline and azithromycin, work in treating murine typhus and scrub typhus. Murine typhus is spread by fleas from rodents, while scrub typhus is spread by mites. Both diseases are caused by bacteria and can be severe if not treated properly. The study is important because it aims to better understand which antibiotic is more effective in clearing the bacteria from the body early on and how these antibiotics impact the severity of the disease. Accurate diagnosis and effective treatment are crucial, as the diseases can be difficult to identify and have varying death rates. Participants in the study will receive either doxycycline or azithromycin to treat their typhus infection. The antibiotics are likely given orally. The effectiveness of the treatment will be measured by checking how quickly and effectively the bacteria are cleared from the body using molecular detection methods like PCR. The study does not mention specific risks but aims to provide more reliable information on how these antibiotics work against the bacteria, potentially leading to better treatment strategies and outcomes for patients. By understanding the treatment response, the study hopes to improve patient care and guide future treatment protocols.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.72 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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 Criteria: * 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: 1. Reduced level of consciousness 2. Clinical jaundice 3. Shock (BP systolic \<80 mmHg) 4. Unable to take oral medication 5. Radiological evidence of pneumonia 6. Clinical evidence for meningitis/encephalitis or the need of LP 7. Alternative diagnosis confirmed that explains the presenting symptoms 8. Any other syndrome which in the opinion of the admitting doctor constitutes severe typhus (reason must be stated)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU)
Vientiane, LaosOpen Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU) in Google MapsVientiane Provincial Hospital
Vientiane Province, Laos