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

NCT ID: NCT02563704

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-03-31

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

Conditions

Malaria

Study Design

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

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Artesunate

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Quinine

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Quinine

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Quinine

Intervention Type: DRUG

Interventions

Artesunate

Intervention Type: DRUG

Quinine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Yaounde 1

OTHER

Sponsor Role: lead

Responsible Party

ETHE MAKA Daniel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elie MBONDA

Role: STUDY_DIRECTOR

Faculty of Medicine and Biomedical Sciences, University of Yaounde I

References

Maka DE, Chiabi A, Obadeyi B, Mah E, Nguefack S, Nana P, Mbacham W, Mbonda E. Economic evaluation of artesunate and three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital-Cameroon: a cost analysis. Malar J. 2016 Dec 7;15(1):587. doi: 10.1186/s12936-016-1639-1.

Reference Type: DERIVED

PMID: 27923381 (View on PubMed)

Other Identifiers

UYaounde1

Identifier Type: -

Identifier Source: org_study_id