Very Severe Malaria Treated by Intravenous Artesunate

NCT04516317 | Completed

• 1 other identifier: P20/18_Palustar
• Study Type: observational
• Target: 578
• Locations: 1 country
• Sites: 1

Brief Summary

In endemic areas, Plasmodium falciparum malaria exacts a huge public health toll, causing close to half a million deaths each year. In non-endemic industrialized areas, imported malaria may develop. In France, around 5000 imported cases occured annually, including 10-15% of severe malaria. The criteria for defining severe malaria in endemic areas are established by the World Health Organization (WHO), and have been adjusted for severe imported malaria. In France, in order to optimize management, severe imported malaria is separated into two groups: very severe malaria (VSM) and less severe malaria (LSM). Briefly VSM included coma and/or shock and/or respiratory failure and/or acidosis and/or hyperlactatemia and/or death during hospitalization. In France, severe imported malaria is treated with intravenous artesunate. Little is known about the management of imported VSM in the ICU with intravenous artesunate. In a French national multicentric retrospective frame, the main objective of the present study is to describe in detail: epidemiology, management, outcome and prognostic of very severe imported malaria treated with intravenous artesunate during the period 2011-2019. The second objective is to retrospectively compare two groups : VSM treated with intravenous artesunate in the ICU during 2011-2019 versus VSM treated with intravenous quinine in the ICU during 2000-2010.

Conditions

Severe Malaria

Keywords

Severe Malaria; Artesunate; Critical Care; Quinine

Outcome Measures

Primary Outcomes (1)

• Mortality rate in the Group intravenous artesunate

  Mortality reported as a mortality rate (%)

  At hospital discharge, an average of 1 month

Secondary Outcomes (1)

• Mortality rates in the Group artesunate and Group quinine

  At hospital discharge, an average of 1 month

Study Arms (2)

Group intravenous artesunate (around 300 patients)

Period 2011-2019

Other: None (Observational study Group intravenous artesunate)

Group intravenous quinine (around 300 patients)

Period 2000-2010

Other: None (Observational study Group intravenous quinine)

Interventions

None (Observational study Group intravenous artesunate) OTHER

Retrospective descriptive study of Group intravenous artesunate

Group intravenous artesunate (around 300 patients)

None (Observational study Group intravenous quinine) OTHER

Retrospective descriptive study of Group intravenous quinine

Group intravenous quinine (around 300 patients)

Eligibility Criteria

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

Study Population

Very severe malaria in adults / Antimalarial treatment (Artesunate period 2011-2019 ; Quinine period 2000-2010)

You may qualify if:

• Hospitalization in the ICU AND
• For severe imported malaria (Plasmodium falciparum) AND
• Very Severe Malaria episode defined during the 72 first hours as :
• Neurological failure: Glasgow Coma Scale score\<11 or repeated convulsions and/or
• Shock: Systolic Blood Pressure\<80 mmHg despite adequate fluid loading or need for vasoactive drugs and/or
• Respiratory distress: Mechanical Ventilation or Non Invasive Ventilation ; or if spontaneous breathing: arterial pO2\<60 mmHg or pulse oxymetry\<92% in room air ; or Respiratory Rate\>32/min and/or
• Acidosis: plasma bicarbonate \<15 mmol/l, or pH\<7,35 and/or
• Hyperlactatemia \> 5 mmol/l and/or
• Death during hospitalization for VSM

You may not qualify if:

• Opposition to participate in the present study

Sponsors & Collaborators

• Dr Fabrice BRUNEEL: lead

Study Sites (1)

Fabrice BRUNEEL

Le Chesnay, Île-de-France Region, 78150, France

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Fabrice BRUNEEL, MD

  Versailles Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator MD

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: August 18, 2020
• Study Start: August 10, 2020
• Primary Completion: March 15, 2022
• Study Completion: March 22, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)