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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

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ClinicalTrials.gov Identifier: NCT02563704
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
ETHE MAKA Daniel, University of Yaounde 1

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

Condition or disease Intervention/treatment Phase
Malaria Drug: Artesunate Drug: Quinine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ARTES
  • 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
Active Comparator: QLD
  • 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
Active Comparator: QNLD3
  • 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
Active Comparator: QNLD2
  • 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



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   3 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563704


Sponsors and Collaborators
University of Yaounde 1
Investigators
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Study Director: Elie MBONDA Faculty of Medicine and Biomedical Sciences, University of Yaounde I
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ETHE MAKA Daniel, MD, University of Yaounde 1
ClinicalTrials.gov Identifier: NCT02563704    
Other Study ID Numbers: UYaounde1
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015
Keywords provided by ETHE MAKA Daniel, University of Yaounde 1:
Artesunate
Quinine
Efficacy
Malaria
Children
Cameroon
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Quinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents