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

Sponsor

University of Yaounde 1 (Other)

Overall Status

Completed

CT.gov ID

NCT02563704

Collaborator

(none)

238

Enrollment

Arms

5.9

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Artesunate Drug: Quinine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

238 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ARTES Injectable Artesunate.Each vial contained 60 mg anhydrous artesunic acid, which was dissolved in 1 ml of 5% sodium bicarbonate (provided with the drug) and then mixed with 5 ml saline solution (provided with the drug) before injecting into an indwelling intravenous catheter. Patients received 2.4 mg/kg bw of parenteral artesunate at H0, H12, H24 and thereafter once daily, for a minimum of 24 hours. Patients exited from the protocol if they had clinically recovered and parasitaemia was negative.	Drug: Artesunate
Active Comparator: QLD Injectable quinine. Each vial contained 250 mg or 500 mg QB. Patients received a loading dose of 16.6 mg/kg bw of QB by intravenous (IV) infusion over 4 hours followed 8 hours after the start of the loading dose, with a maintenance dose of QB at 8.3 mg/kg bw over 4 hours every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution. Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.	Drug: Quinine
Active Comparator: QNLD3 Injectable quinine. Each vial contained 250 mg or 500 mg QB. Patients received 8.3 mg/kg bw of QB over 4 hours by IV infusion every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution. Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.	Drug: Quinine
Active Comparator: QNLD2 Injectable quinine. Each vial contained 250 mg or 500 mg QB. Patients received 12.5 mg/kg bw of QB over 4 hours by IV infusion every 12 hours diluted in 10 ml/kg bw of 10% dextrose solution. Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative.	Drug: Quinine

Outcome Measures

Primary Outcome Measures

Fever clearance time [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 (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 (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 (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 (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 [24 hours from onset of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)