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Completed

NCT Number: 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

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

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

3 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artesunate

Drug

Quinine

Drug

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Parasite reduction rate 24 hours after onset of treatment

    Time frame: 24 hours from onset of treatment

Sponsors and collaborators

Lead sponsor

University of Yaounde 1

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 30, 2015
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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