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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Plasmodium Infections	Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS); Drug: primaquine (PQ) plus SP+AS	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	104 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	January 2004
Actual Study Completion Date :	November 2004

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1; 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)
Experimental: 2; Sulfadoxine pyrimethamine plus artesunate plus primaquine	Drug: primaquine (PQ) plus SP+AS; single dose of primaquine on day 4

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Presence of gametocytes detected by RT-PCR on days 3, 7 and 14. [ Time Frame: 14 days from start of treatment ]
2. Packed Cell volume on days 7 and 14. [ Time Frame: Over 14 days from start of treatment ]

Eligibility Criteria

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Ages Eligible for Study:	3 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00330902 History of Changes
Other Study ID Numbers:	SGS64
First Posted:	May 29, 2006
Last Update Posted:	October 31, 2007
Last Verified:	October 2007

Keywords provided by London School of Hygiene and Tropical Medicine:

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

Additional relevant MeSH terms:

Infection; Malaria; Parasitemia; Protozoan Infections; Parasitic Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Artesunate; Artemisinins; Primaquine; Pyrimethamine	Sulfadoxine; Fanasil, pyrimethamine drug combination; Amebicides; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Antimalarials; Folic Acid Antagonists; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Urinary; Renal Agents