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 1

Status and phase: Completed; Phase 3

Conditions: Malaria

Treatments: Drug: Quinine; Drug: Artesunate

Study type: Interventional

Funder types: Other

Identifiers

NCT02563704

UYaounde1

Details and patient eligibility

About

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

Enrollment: 238 patients

Sex: All

Ages: 3 months to 15 years old

Volunteers: No 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)

Exclusion criteria

• Prior side effects to either artesunate or quinine administration
• Severely malnourished children
• Concomitant infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 4 patient groups

ARTES

Active Comparator group

Description:

* 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.

Treatment:

Drug: Artesunate

QLD

Active Comparator group

Description:

* 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.

Treatment:

Drug: Quinine

QNLD3

Active Comparator group

Description:

* 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.

Treatment:

Drug: Quinine

QNLD2

Active Comparator group

Description:

* 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.

Treatment:

Drug: Quinine