A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon

University of Yaounde 1238 enrolled

Overview

The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate with three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital located in the South region of Cameroon

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

238

Conditions

Malaria

Interventions

ArtesunateDRUG

QuinineDRUG

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children presenting with one or more signs of severity of malaria according to the 2013 Cameroon National Malaria Control Programme adopted criteria (impaired consciousness, abnormal behaviour, convulsions, prostration, persistent vomiting, jaundice, hyperthermia, acute respiratory distress, clinical acidosis, haemoglobinuria, cardiovascular shock, dehydration, abnormal bleeding, severe anaemia, renal impairment, hypoglycaemia and hyperparasitaemia) * and having an initial positive parasitaemia to Plasmodium falciparum * Other aetiologies of the presenting symptoms excluded * Written consent from parent(s) Exclusion Criteria: * Prior side effects to either artesunate or quinine administration * Severely malnourished children * Concomitant infection

Outcomes

Primary Outcomes

Fever clearance time

Time frame: Time (in hours) from the onset of treatment till rectal temperature went down to 37.5°C for at least 24 hour

Coma recovery time

Time frame: Time (in hours) from the onset of treatment till the participant was fully conscious with a BCS of 5 or GCS of 15 for an average of 24 hours

Time to sit unsupported

Time frame: Time (in hours) from the onset of treatment till when the participant could sit unsupported for an average of 24 hours if the participant was unable to do so on admission

Time to eat and drink

Time frame: Time (in hours) from the onset of treatment till when the participant could eat and drink for an average of 24 hours if the participant was unable to do so on admission

Parasite clearance time

Time frame: Time (in hours) from the onset of treatment to the time of the first of two successive negative blood smear through hospital discharge, an average of one week

Parasite reduction rate 24 hours after onset of treatment

Time frame: 24 hours from onset of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.