Artemisinin Resistance In Malaria Treated With IV Artesunate

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The spread of artemisinin resistant falciparum malaria presents new challenges to both the control and treatment of malaria. Loss of ring stage susceptibility to the artemisinins might jeopardize the use of parenteral artesunate as the first line drug for the treatment of severe falciparum malaria.

The purpose of this study is to assess the effect of artemisinin resistance (defined by a Kelch13 mutation with known functional significance) in P. falciparum malaria requiring parenteral artesunate treatment on lactate clearance parameters.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Mahidol Oxford Tropical Medicine Research Unit; Oxford University Clinical Research Unit, Vietnam
• Treatments: Artemisinine; Artemisinins; Artesunate

Criteria

Inclusion Criteria:

• Male or female, aged over 6 months old

• Acute severe P. falciparum malaria or another indication to treat with IV artesunate. Defined as one or more of the following, occurring in the absence of an identified alternative cause, and in the presence of P. falciparum asexual parasitaemia:

• Prostration OR obtundation

• BCS<3 (preverbal children) or GCS<11 (adults)

• Convulsion in last 24 hours

• Suspected acidosis, manifesting as acidotic breathing

• Respiratory distress manifesting clinically (nasal flaring/indrawing) or oxygen saturation <92% or respiratory rate >30/min

• History of anuria

• Jaundice and/or hemoglobinuria

• Hemoglobin <7 g/dl or hematocrit <20%

• Significant bleeding including recurrent or prolonged bleeding from nose gums or venipuncture sites; hematemesis or melena

• Shock defined as systolic blood pressure <70 mm Hg (children) OR <80 mm Hg (adults)

• P. falciparum parasitaemia >10%

• Indication for parenteral antimalarial treatment (as assessed by clinician) other than nausea and vomiting. These may include laboratory findings such as:

• Creatinine >2.5 mg/dL (>220uM/L) or blood urea >56mg/dL (>20 mM/L)

• Glucose <4.0 mmol/L (<72mg/dL)

• Bilirubin > 3 mg/dL (>50uM/L)

• Hemoglobin <7g/dL or Hematocrit <20%

• P. falciparum parasitaemia >4%

• Venous plasma lactate >5 mM, Base deficit of >8meq/L or bicarbonate <15mM

• Written informed consent or consent by locally accepted representative in the case of patients rendered incapable of providing consent due to illness

Exclusion Criteria:

• History of 2 or more doses of parenteral antimalarial treatment in the previous 24 hours

• History of allergy or known contraindication to artemisinins