search
Back to results

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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Artesunate
Quinine
Sponsored by
University of Yaounde 1
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Artesunate, Quinine, Efficacy, Malaria, Children, Cameroon

Eligibility Criteria

3 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    ARTES

    QLD

    QNLD3

    QNLD2

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Fever clearance time
    Coma recovery time
    Time to sit unsupported
    Time to eat and drink
    Parasite clearance time
    Parasite reduction rate 24 hours after onset of treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    September 19, 2015
    Last Updated
    September 30, 2015
    Sponsor
    University of Yaounde 1
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02563704
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Yaounde 1

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria
    Keywords
    Artesunate, Quinine, Efficacy, Malaria, Children, Cameroon

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    238 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ARTES
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    QLD
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    QNLD3
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    QNLD2
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Artesunate
    Intervention Type
    Drug
    Intervention Name(s)
    Quinine
    Primary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    Parasite reduction rate 24 hours after onset of treatment
    Time Frame
    24 hours from onset of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elie MBONDA
    Organizational Affiliation
    Faculty of Medicine and Biomedical Sciences, University of Yaounde I
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27923381
    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.
    Results Reference
    derived

    Learn more about this trial

    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

    We'll reach out to this number within 24 hrs