Malaria
Conditions
Brief summary
The WHO recommends artesunate as the drug of choice for the treatment of severe malaria. However, the efficacy of this single drug as compared to the combined drug regimen remained questionable, and the clinical response was considered delayed or inappropriate. Therefore, this research intended to evaluate the efficacy of only IV artesunate versus IV artesunate plus IV quinine in the treatment of severe malaria in children. The findings of the study would be helpful knowing whether the two drugs, when given together, have considerable benefit over single-drug therapy when given for the same.
Interventions
DRUGIV Artesunate
IV artesunate with a weight-appropriate dosage at 0, 12, 24, and 48 hours and continued 12-hourly for a maximum duration of seven days, with each dose diluted in normal saline and given as an infusion.
DRUGIV Quinine Hydrochloride
IV Quinine hydrochloride in accordance to weight with loading dose 20mg salt/kg in 10% dextrose infusion followed by 10mg salt/kg infusion 8 hourly for 2 days and for 12 hourly onwards for a maximum of 7 days.
Sponsors
RESnTEC, Institute of Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
Children admitted to the emergency department with the diagnosis of severe malaria.
Exclusion criteria
Children with chronic kidney disease, chronic liver disease, immunosuppressive disorders, hematological disorders, malignancies, and congenital heart disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy measurement between IV Artesunate and IV Artesunate plus IV Quinine Hydrochloride | Seven days | The outcome was measured in the number of hours elapsed for an individual to become fever-free. |
Countries
Pakistan
Outcome results
None listed