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

NCT02563704 | Completed Phase 3

• 1 other identifier: UYaounde1
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

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

Keywords

Artesunate; Quinine; Efficacy; Malaria; Children; Cameroon

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

ARTES

ACTIVE COMPARATOR

* 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

QLD

ACTIVE COMPARATOR

* 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

QNLD3

ACTIVE COMPARATOR

* 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

QNLD2

ACTIVE COMPARATOR

* 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

Interventions

Artesunate DRUG

ARTES

Quinine DRUG

QLD; QNLD2; QNLD3

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Yaounde 1: lead

Related Publications (1)

• 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.

  PMID: 27923381 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Artesunate; Quinine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Elie MBONDA

  Faculty of Medicine and Biomedical Sciences, University of Yaounde I

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 19, 2015
• First Posted: September 30, 2015
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 1, 2015

Record last verified: 2015-09