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

This study has been completed.
Tropical Medicine Research Institute
World Health Organization
Information provided by:
London School of Hygiene and Tropical Medicine Identifier:
First received: May 25, 2006
Last updated: October 30, 2007
Last verified: October 2007
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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
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

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.

Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00330902

Tropical Medicine Research Institute
Khartoum, Sudan
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Tropical Medicine Research Institute
World Health Organization
Principal Investigator: Badria B El Sayed, PhD TMRI, Khartoum
Study Chair: Omer Z Baraka, MD Faculty of Medicine, University of Khartoum
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00330902     History of Changes
Other Study ID Numbers: SGS64
Study First Received: May 25, 2006
Last Updated: October 30, 2007

Keywords provided by London School of Hygiene and Tropical Medicine:
subpatent parasitaemia
dry season
Plasmodium falciparum infection detected by PCR

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Fanasil, pyrimethamine drug combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017