A Trial of the Efficacy of Artesunate and Three Quinine R... | NCT02563704

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Name	Type	Description	Arm Group Labels	Other Names
Artesunate	Drug		ARTES
Quinine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Module

Name	Affiliation	Role
Elie MBONDA	Faculty of Medicine and Biomedical Sciences, University of Yaounde I	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27923381	Derived	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.

ID	Term
D008288	Malaria

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases

ID	Term
D000077332	Artesunate
D011803	Quinine

Ancestor Terms

ID	Term
D037621	Artemisinins
D017382	Reactive Oxygen Species
D005609	Free Radicals
D007287	Inorganic Chemicals
D009930	Organic Chemicals
D012717	Sesquiterpenes
D013729	Terpenes
D006838	Hydrocarbons
D002930	Cinchona Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring