Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission - Full Text View

Sponsors and Collaborators:	Tropical Medicine Research Institute London School of Hygiene and Tropical Medicine International Atomic Energy Agency
Information provided by:	Tropical Medicine Research Institute
ClinicalTrials.gov Identifier:	NCT00646126

Purpose

The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. Targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. We are conducting a randomized double blind placebo controlled mass drug administration trial in eight village to clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in eastern Sudan.

Condition	Intervention	Phase
Plasmodium Falciparum Asymptomatic Parataemia Sub Patent Parasitaemia	Drug: Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS) Drug: placebo tablet similar to active drug in shape and size	Phase III

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Sulfadoxine Artesunate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Validation of the Use of Istope-Based Molecular Techniques for Malaria Control

Further study details as provided by Tropical Medicine Research Institute:

Primary Outcome Measures:

Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages [ Time Frame: October to December 2006 ]

Secondary Outcome Measures:

1. Malaria prevalence during the transmission season 2. Frequency of mutation in drug resistance genes

Study Start Date:

August 2005

Arms	Assigned Interventions
1: Active Comparator 1:Active comparator sulfadoxine-pyrimethamine plus artesunate	Drug: Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS) Standard three day regimen
2: Placebo Comparator 2:placebo comparator	Drug: placebo tablet similar to active drug in shape and size Dosage similar to active drug(standard three days regimen)

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

All residents of the 8 villages

Exclusion Criteria:

Pregnancy
History of allergy to sulfa drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646126

Locations

Sudan
Tropical Medicine Research Institute
Khartoum, Sudan, 11111

Sponsors and Collaborators

Tropical Medicine Research Institute

London School of Hygiene and Tropical Medicine

International Atomic Energy Agency

Investigators

Principal Investigator:

Badria B El Sayed, PhD,MSc,BSc

Tropical Medicine Research Institute

More Information

Study ID Numbers:	SUD 6/025
Study First Received:	March 25, 2008
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00646126
Health Authority:	Sudan: Ministry of Health

Study placed in the following topic categories:

Folic Acid
Artesunate
Pyrimethamine
Systemic Inflammatory Response Syndrome
Sepsis

Parasitemia
Parasitic Diseases
Malaria
Sulfadoxine
Inflammation

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009