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

NCT ID: NCT06472258

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-06-30

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV Artesunate Group

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.

Group Type: EXPERIMENTAL

IV Artesunate

Intervention Type: 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.

Combination Group

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.

Group Type: EXPERIMENTAL

IV Artesunate

Intervention Type: 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.

IV Quinine Hydrochloride

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Artesunate; Artesunate plus IV Quinine Hydrochloride

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RESnTEC, Institute of Research

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Aamir Latif

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Allama Iqbal Teaching Hospital

Dera Ghazi Khan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

DGKhan

Identifier Type: -

Identifier Source: org_study_id