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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563704
• Other study ID #: UYaounde1
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2015
• Last updated: September 30, 2015
• Start date: September 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2015
• Source: University of Yaounde 1
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cameroon: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Artesunate

• Quinine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Yaounde 1

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Parasite reduction rate 24 hours after onset of treatment		24 hours from onset of treatment	No