Clinical trial NCT00330902: Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plasmodium Infections
Keywords: malaria
subpatent parasitaemia
dry season
primaquine
Plasmodium falciparum infection detected by PCR
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Tropical Medicine Research Institute
name: World Health Organization
First posted: 2006-05-29
Enrollment: 104
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: P.falciparum parasitaemia detected by PCR on days 3,7 and 14.
timeFrame: 14 days from start of treatment
Secondary outcomes:
measure: Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.
timeFrame: 14 days from start of treatment
measure: Packed Cell volume on days 7 and 14.
timeFrame: Over 14 days from start of treatment
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Tropical Medicine Research Institute
Study officials:
affiliation: TMRI, Khartoum
name: Badria B El Sayed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, University of Khartoum
name: Omer Z Baraka, MD
role: STUDY_CHAIR
References:
citation: El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.