Artemisinin Resistance In Malaria Treated With IV Artesunate

NCT02640495 | Withdrawn DMC

• 1 other identifier: BAKMAL1504
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malaria

Keywords

Treatment Efficacy; drug resistance; Artemisinin

Outcome Measures

Primary Outcomes (1)

• Absolute reduction of lactate

  Absolute reduction of lactate at 12 hours after the first artesunate treat-ment compared to baseline.

  12 hours

Secondary Outcomes (33)

• Time needed until a plasma lactate concentration <2 mmol/L

  42 days

• Change in Glasgow Coma Score (GCS) or Blantyre Coma Score (BCS)

  12 hours

• Base excess clearance after 12 hours

  42 days

• Time until a base excess concentration ≥ minus 2 mmol/L

  42 days

• Time to resuming the ability to sit, eat, drink, stand unsupported and walk

  42 days

Study Arms (1)

Study subjects

Patients admitted with malaria, caused by Plasmodium falciparum, treated with parenteral artesunate.

Drug: Intravenous Artesunate as part of standard medical practice

Interventions

Intravenous Artesunate as part of standard medical practice DRUG

Intravenous Artesunate 2.4 mg/kg

Study subjects

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with malaria, caused by Plasmodium falciparum, treated with parenteral artesunate.

You may qualify if:

• 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)

You may not qualify if:

• History of 2 or more doses of parenteral antimalarial treatment in the previous 24 hours
• History of allergy or known contraindication to artemisinins

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• Oxford University Clinical Research Unit, Vietnam: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Prof. Arjen M Dondorp, MD

  Mahidol Oxford Research Unit (MORU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: December 29, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 22, 2018

Record last verified: 2018-08