Optimal treatment for a potentially life threatening infection called scrub typhus
- Conditions
- Health Condition 1: A753- Typhus fever due to Rickettsia tsutsugamushiHealth Condition 2: A753- Typhus fever due to Rickettsia tsutsugamushiHealth Condition 3: A753- Typhus fever due to Rickettsia tsutsugamushi
- Registration Number
- CTRI/2018/08/015159
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 809
All of the following criteria must be met:
•Age =15 years old presenting with fever
•Scrub typhus rapid test (RDT) positivity and/or presence of an eschar
•Severe scrub typhus as per the criteria A or requiring IV treatment as decided by the attending physician
•Willingness to participate in the study and written informed consent obtained from the patient / the patient’s parent(s), guardian(s) or representative(s) where necessary
The participant may not enter the study if ANY of the following apply:
1.Pregnancy or breastfeeding
2.Current tuberculosis (rifampicin has activity against O. tsutsugamushi)
3.Documented HIV infection, long term use of steroids, chemotherapy, other immunosuppressant therapy
4.Taking medicines that may interact with study drugs
5.Known allergy to either of the medications
6.Patients who have received azithromycin or doxycycline or chloramphenicol for more than 24 hours within 3 days prior to recruitment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment success as measured as a composite of survival at 28 days, lack of persisting complications at day 7 and lack of fever at day 5Timepoint: Day28
- Secondary Outcome Measures
Name Time Method Adverse events <br/ ><br>Timepoint: Up to Day 28;Measurement of serial drug levels andO. tsutsugamushi bacterial counts (by qPCR) in bloodTimepoint: Days 1, 3, 7& 10-14;Number of deaths <br/ ><br>Timepoint: Day 28