Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study

RESnTEC, Institute of Research

Status: Completed

Conditions: Malaria

Treatments: Drug: IV Artesunate; Drug: IV Quinine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06472258

DGKhan

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

IV Artesunate Group

Experimental group

Description:

IV Artesunate with weight appropriate dosage on 0, 12, 24 and 48 hours, and continued 12 hourly for a maximum duration of seven days. Each dose diluted in normal saline given as infusion.

Treatment:

Drug: IV Artesunate

Combination Group

Experimental group

Description:

IV Artesunate with weight appropriate dose on 0, 12, 24 and 48 hours, plus 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.

Treatment:

Drug: IV Quinine Hydrochloride

Drug: IV Artesunate