A Phase 3 interventional study of Artesunate and Quinine in Malaria, sponsored by University of Yaounde 1. Completed. Open to participants aged 3 Months to 15 Years. Per ClinicalTrials.gov, last updated 2015-10-01.
Sponsored by University of Yaounde 1 · Phase 3, Interventional, and Treatment
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
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 238 is close to the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →University of Yaounde 1 is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
* 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
* 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
* 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
* 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
Fever clearance time
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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
Time frame: 24 hours from onset of treatment
No study locations are listed for this record.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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University of Yaounde 1