Health Condition 1: A753- Typhus fever due to Rickettsia tsutsugamushi Health Condition 2: A753- Typhus fever due to Rickettsia tsutsugamushi Health Condition 3: A753- Typhus fever due to Rickettsia tsutsugamushi
Conditions
Interventions
Intervention1: IV Azithromycin: Day 1,Dose 1( Infusion 1):Azithro 500mg in 250ml NS over 1 hr
Day 1, Dose1 ( Infusion 2):Polybion in 250ml NS over 2 hrs
Day 1, Dose 2 ( Infusion 1):Azithro 500mg
In
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Adverse events 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 Timepoint: Day 28 | — |
Countries
India, Lao People's Democratic Republic, Thailand
Contacts
Public ContactRoshini G
Christian Medical College
Outcome results
None listed