Clinical Trials Directory

Trials / Completed

CompletedNCT01828333

Malaria Treatment With Injectable ArteSunate

Treatment of Severe Malaria - An Operational Comparative Study Between Quinine and Artesunate for the Treatment of Severe Malaria in Hospitals and Health Centers of Kinshasa and Lower Congo

Status
Completed
Phase
Study type
Observational
Enrollment
350 (actual)
Sponsor
Swiss Tropical & Public Health Institute · Academic / Other
Sex
All
Age
2 Months
Healthy volunteers
Not accepted

Summary

The MATIAS study aims to demonstrate through limited scope implementation studies how injectable artesunate may be progressively rolled out nationwide in the Democratic Republic of the Congo as the preferred treatment for severe malaria.

Detailed description

In 2010 the AQUAMAT study demonstrated that the treatment of severe malaria with artesunate in children reduced the case fatality substantially. An overall reduction of 22.5 % of mortality in African children (\< 15 years) was reported using injectable artesunate compared to injectable quinine for treatment of severe malaria caused by Plasmodium falciparum. These results with high quality evidence led to a change in the WHO guidelines for the treatment of severe malaria in 2011. The WHO now recommends intravenous artesunate as the treatment of choice for severe malaria in children and adults. In early 2012 the Programme National de Lutte contre of Paludisme (PNLP) of the DRC with support from the relevant ministry departments decided to follow the WHO guidelines and changed the policy for the treatment of severe malaria in children and adults from injectable quinine to injectable artesunate. However, this process is a complex undertaking, requiring many operational and clinical adaptations. In order to support this process, there is a need for on-site operational information on the process and consequences of the switch from quinine to artesunate. The MATIAS study aims to demonstrate through limited scope implementation studies how injectable artesunate may be progressively rolled out nationwide in the Democratic Republic of the Congo as the preferred treatment for severe malaria.

Conditions

Interventions

TypeNameDescription
OTHERNo interventionNo intervention

Timeline

Start date
2013-04-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2013-04-10
Last updated
2013-09-13

Locations

9 sites across 1 country: Democratic Republic of the Congo

Source: ClinicalTrials.gov record NCT01828333. Inclusion in this directory is not an endorsement.