Clinical Trial: Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan

Brief Summary: In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.

Detailed Summary: 104 individuals with low density Plasmodium falciparum infection detected by polymerase chain reaction (PCR) were randomized to receive sulfadoxine-pyrimethamine and three daily doses of artesunate (SP+AS) or SP+AS and a dose of primaquine (SP+AS+PQ), and were followed up for 14 days during the transmission-free season in Eastern Sudan. Subjects were visited on days 3, 7 and 14 after the start of treatment to record any adverse events and to detect P.falciparum using PCR. PCR positive samples were tested for gametocytes using RT-PCR. Packed cell volume was measured on days 7 and 14.
Sponsor: London School of Hygiene and Tropical Medicine

Current Primary Outcome: P.falciparum parasitaemia detected by PCR on days 3,7 and 14. [ Time Frame: 14 days from start of treatment ]

Original Primary Outcome: P.falciparum parasitaemia detected by PCR on days 3,7 and 14.

Current Secondary Outcome:

  • Presence of gametocytes detected by RT-PCR on days 3, 7 and 14. [ Time Frame: 14 days from start of treatment ]
  • Packed Cell volume on days 7 and 14. [ Time Frame: Over 14 days from start of treatment ]


Original Secondary Outcome:

  • Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.
  • Packed Cell volume on days 7 and 14.


Information By: London School of Hygiene and Tropical Medicine

Dates:
Date Received: May 25, 2006
Date Started: January 2004
Date Completion:
Last Updated: October 30, 2007
Last Verified: October 2007