Health Condition 1: A753- Typhus fever due to Rickettsia tsutsugamushi
Conditions
Interventions
Intervention1: Group 3: Combination therapy: Group 3: Combination therapy ( Azithromycin and doxycycline at above dosages)
Control Intervention1: Group 1: Doxycycline plus placebo for 7 days.
: Group
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in the trial if they meet all the following criteria: Children aged 1 month-18 years Suffering from scrub typhus (acute febrile illness of atleast 5 days) with a positive result on Scrub Typhus Rapid diagnostic test or presented with an eschar. Atleast one organ -system involvement as per the Pediatric sequential organ failure assessment (pSOFA) scoring Fever of less than 5 days will be considered in case of co-presence of eschar or positive scrub RDT or IgM serology with cutoff optical density greater than or equal to 0.5 or a positive RT-PCR report.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they meet any of the following criteria: Prior treatment with tetracyclines, macrolides, rifampicin or chloramphenicol for more than 24 hours within 48 hours before recruitment. Lethal congenital anomaly or known immundeficiency. History of hypersensitivity to macrolides or tetracylines Denied consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be a composite of all-cause mortality within 14 days, persistent complications on day 7, and persistent fever ( more than 37.5 C) on day 5. Timepoint: 14 days, day 7, day 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome: will include 14-day all-cause mortality, fever defervescence at day 5, Time to fever resolution, persistent complications at day 7, hospitalization stay, and adverse events.Timepoint: Day 5, Day 7 and Day 14 | — |
Countries
India
Contacts
Public ContactVidushi Mahajan
Government Medical College and Hospital Chandigarh
Outcome results
None listed