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

This study has been completed.
Sponsor:
Collaborators:
Tropical Medicine Research Institute
World Health Organization
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00330902
First received: May 25, 2006
Last updated: October 30, 2007
Last verified: October 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Malaria
U.S. FDA Resources

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.

  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

No publications provided by London School of Hygiene and Tropical Medicine

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

ClinicalTrials.gov Identifier: NCT00330902     History of Changes
Other Study ID Numbers: SGS64
Study First Received: May 25, 2006
Last Updated: October 30, 2007
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

Additional relevant MeSH terms:
Malaria
Parasitemia
Protozoan Infections
Parasitic Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Primaquine
Pyrimethamine
Sulfadoxine
Artesunate
Sulfadoxine-pyrimethamine
 Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on May 21, 2013