Clinical trial NCT02563704: 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
Official title: A Randomized Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: Artesunate
Quinine
Efficacy
Malaria
Children
Cameroon
Lead sponsor: University of Yaounde 1
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 238
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Fever clearance time
timeFrame: Time (in hours) from the onset of treatment till rectal temperature went down to 37.5°C for at least 24 hour
measure: Coma recovery time
timeFrame: 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
measure: Time to sit unsupported
timeFrame: 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
measure: Time to eat and drink
timeFrame: 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
measure: Parasite clearance time
timeFrame: 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
measure: Parasite reduction rate 24 hours after onset of treatment
timeFrame: 24 hours from onset of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine and Biomedical Sciences, University of Yaounde I
name: Elie MBONDA
role: STUDY_DIRECTOR
References:
citation: 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.