Trial | NCT00330902  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    104
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.
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.
Study Started
Jan 31
2004
Study Completion
Nov 30
2004
Last Update
Oct 31
2007
Estimate

Drug sulfadoxine-pyrimethamine (SP) plus artesunate (AS)

sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)

Drug primaquine (PQ) plus SP+AS

single dose of primaquine on day 4

1 Active Comparator

Sulfadoxine pyrimethamine plus three daily doses of artesunate

2 Experimental

Sulfadoxine pyrimethamine plus artesunate plus primaquine

Criteria 

Inclusion Criteria:

infection with P.falciparum detected by PCR

Exclusion Criteria:

pregnancy
severe anaemia
fever or other signs of illness
history of allergy to sulfa drugs
presence of other species of Plasmodium detected by microscopy
No Results Posted