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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00330902

Enrollment

104

Registered

2006-05-29

Start date

2004-01-31

Completion date

2004-11-30

Last updated

2007-10-31

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

Conditions

Plasmodium Infections

Keywords

malaria, subpatent parasitaemia, dry season, primaquine, Plasmodium falciparum infection detected by PCR

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 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.

Interventions

DRUGsulfadoxine-pyrimethamine (SP) plus artesunate (AS)

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

DRUGprimaquine (PQ) plus SP+AS

single dose of primaquine on day 4

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
P.falciparum parasitaemia detected by PCR on days 3,7 and 14.	14 days from start of treatment

Secondary

Measure	Time frame
Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.	14 days from start of treatment
Packed Cell volume on days 7 and 14.	Over 14 days from start of treatment

Countries

Sudan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026