Health Condition 1: A753- Typhus fever due to Rickettsia tsutsugamushi
Conditions
Interventions
Intervention1: Azithromycin: 10mg/Kg/Day once daily for 5 days
Control Intervention1: Doxycycline: 4.5mg/kg/day divided Q 12 Hourly for 5 days
Sponsors
Dr Joseph John
Dr Amit Kumar Satapathy
Dr Bijayani Behera
Dr Biswa Mohan Padhy
Dr Karthika I K
Dr Suchanda Sahu
Eligibility
Inclusion criteria
Inclusion criteria: Patients falling under the â??suspected, probable and confirmed case definitions â?? as per IAP guidelines on Ricketssial diseases in children based on clinical and epidemiological criterias
Exclusion criteria
Exclusion criteria: Patients with a known allergy to either of these drugs Patients participating in other clinical trials Children with any other known systemic illness Children with any major congenital malformations  Children who have received antimicrobial drugs with antirickettsial activity in the preceeding 2 weeks (doxycycline/azithromycin/chloramphenicol/rifampicin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of two drugs in terms of percentage of children who attained remission of fever after 72 hours of administration of first dose of the study drugTimepoint: After 72 hours of administration of first dose of the study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse drug events of the medications being usedTimepoint: On a daily basis;Clinical resolution of hepatosplenomegaly and lymphadenopathy. Timepoint: On a daily basis;Rate of treatment failuresTimepoint: After 72 hours;Time required for normalization of a)Liver enzymes - AST and ALT between 40 U/L b)Thrombocytopenia - Platelet count 1.5 lakhs c)Hyponatremia - Serum Sodium 135 mEq/L d)Hypoalbuminemia- Albumin 3.5g/dLTimepoint: On Day 3 and Day 5 and in selected cases who have not responded to repeat after 1 week of administration of the study drug;Time taken for defervescence of fever for either drug after the first dose of drugTimepoint: Monitored every 4 hourly | — |
Countries
India
Contacts
Public ContactDr Karthika I K
All India Institute of Medical Sciences, Bhubaneswar
Outcome results
None listed