Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission

This study has been completed.
London School of Hygiene and Tropical Medicine
International Atomic Energy Agency
Information provided by:
Tropical Medicine Research Institute Identifier:
First received: March 25, 2008
Last updated: March 27, 2008
Last verified: August 2005

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Validation of the Use of Istope-Based Molecular Techniques for Malaria Control

Resource links provided by NLM:

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


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

Inclusion Criteria:

  • All residents of the 8 villages

Exclusion Criteria:

  • Pregnancy
  • History of allergy to sulfa drugs
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Please refer to this study by its identifier: NCT00646126

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
Principal Investigator: Badria B El Sayed, PhD,MSc,BSc Tropical Medicine Research Institute
  More Information

No publications provided Identifier: NCT00646126     History of Changes
Other Study ID Numbers: SUD 6/025
Study First Received: March 25, 2008
Last Updated: March 27, 2008
Health Authority: Sudan: Ministry of Health processed this record on March 03, 2015