CompletedPhase 3

Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients

Burkina Faso, Cambodia, Côte d’Ivoire1,271 participantsStarted 2007-01

Plain-language summary

The primary objective of this phase III clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of the combination of mefloquine plus artesunate (MQ + AS) in children and adults with uncomplicated P falciparum malaria in South East Asia, India and Africa.

Who can participate

Age range3 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or documented history of fever in the previous 24 hours and,
✓. Positive microscopy of P. falciparum with parasite density between 1,000 and 100,000 asexual parasite count/µl of blood

What they're measuring

Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28

Timeframe: Day 28

Trial details

NCT IDNCT00403260

SponsorMedicines for Malaria Venture

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-10

Results submitted2021-08-20

View on ClinicalTrials.gov More Falciparum Malaria trials