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A randomised community based study to assess the safety, efficacy of dihydroartemisinin-piperaquine (artekin) for the treatment of uncomplicated falciparum malaria

A randomised community based study to assess the safety, efficacy of dihydroartemisinin-piperaquine (artekin) for the treatment of uncomplicated falciparum malaria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50708498
Enrollment
Unknown
Registered
2005-10-14
Start date
2002-08-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations Malaria

Interventions

Open label randomised controlled trial comparing the efficacy of dihydroartemisinin-piperaquine to that of the antimalarial treatment in current use i.e. mefloquine-artesunate three-day regimen (MAS3)

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults or children 2. Symptomatic of malaria infection, i.e. history of fever or presence of fever more than 37.5 °C 3. Microscopic confirmation of asexual stages of P. falciparum or mixed infection (5/500 white blood cells)

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation 2. P.falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175,000 /µl) 3. Signs or symptoms of severe malaria

Design outcomes

Primary

MeasureTime frame
The 56 day (community) cure rates are the markers of therapeutic efficacy for this trial.—

Secondary

MeasureTime frame
Secondary endpoints are frequency of adverse events in the two Artekin groups.—

Countries

Viet Nam

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026