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

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allama Iqbal Teaching Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IV Artesunate

Drug

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.

Other names: Artesunate

IV Quinine Hydrochloride

Drug

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.

Other names: Artesunate plus IV Quinine Hydrochloride

Primary outcomes

Efficacy measurement between IV Artesunate and IV Artesunate plus IV Quinine Hydrochloride

Time frame: Seven days

The outcome was measured in the number of hours elapsed for an individual to become fever-free.

Sponsors and collaborators

Lead sponsor

RESnTEC, Institute of Research

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jun 25, 2024
Registry last updated: Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed