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Clinical trial

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

ID
Name
DGKhan
Description
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.
Trial arms
Trial start
2023-03-01
Estimated PCD
2023-06-30
Trial end
2023-06-30
Status
Completed
Treatment
IV 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.
Arms:
Combination Group, IV Artesunate Group
Other names:
Artesunate
IV 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.
Arms:
Combination Group
Other names:
Artesunate plus IV Quinine Hydrochloride
Size
104
Primary endpoint
Efficacy measurement between IV Artesunate and IV Artesunate plus IV Quinine Hydrochloride
Seven days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}
Updated at
2024-06-26

1 organization

2 products

1 indication

Organization
Resntec Institute of Research
Product
Artesunate
Indication
Malaria
Product
Quinine Hydrochloride