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

Sponsors and Collaborators:	London School of Hygiene and Tropical Medicine Tropical Medicine Research Institute World Health Organization
Information provided by:	London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00330902

Purpose

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.

Condition	Intervention	Phase
Plasmodium Infections	Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS) Drug: primaquine (PQ) plus SP+AS	Phase III

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Sulfadoxine Artesunate Fansidar Primaquine Primaquine phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	104
Study Start Date:	January 2004
Study Completion Date:	November 2004

Arms	Assigned Interventions
1: Active Comparator Sulfadoxine pyrimethamine plus three daily doses of artesunate	Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS) sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)
2: Experimental Sulfadoxine pyrimethamine plus artesunate plus primaquine	Drug: primaquine (PQ) plus SP+AS single dose of primaquine on day 4

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

Ages Eligible for Study:	3 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330902

Locations

Sudan
Tropical Medicine Research Institute
Khartoum, Sudan

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Tropical Medicine Research Institute

World Health Organization

Investigators

Principal Investigator:	Badria B El Sayed, PhD	TMRI, Khartoum
Study Chair:	Omer Z Baraka, MD	Faculty of Medicine, University of Khartoum

More Information

Publications indexed to this study:

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.

Study ID Numbers:	SGS64
Study First Received:	May 25, 2006
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00330902
Health Authority:	Sudan: Ministry of Health

Keywords provided by London School of Hygiene and Tropical Medicine:

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

Study placed in the following topic categories:

Folic Acid
Artesunate
Pyrimethamine
Protozoan Infections
Sulfadoxine-pyrimethamine

Primaquine
Parasitemia
Parasitic Diseases
Malaria
Sulfadoxine

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Coccidiosis
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents

Infection
Folic Acid Antagonists
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Amebicides

ClinicalTrials.gov processed this record on January 15, 2009