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

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 3

Conditions: Plasmodium Infections

Treatments: Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS); Drug: primaquine (PQ) plus SP+AS

Study type: Interventional

Funder types: Other

Identifiers

NCT00330902

SGS64

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

1

Active Comparator group

Description:

Sulfadoxine pyrimethamine plus three daily doses of artesunate

Treatment:

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

2

Experimental group

Description:

Sulfadoxine pyrimethamine plus artesunate plus primaquine

Treatment:

Drug: primaquine (PQ) plus SP+AS