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

March 27, 2008 updated by: Tropical Medicine Research Institute

Validation of the Use of Istope-Based Molecular Techniques for Malaria Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
      • Khartoum, Sudan, 11111
        • Tropical Medicine Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All residents of the 8 villages

Exclusion Criteria:

  • Pregnancy
  • History of allergy to sulfa drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tropical Medicine Research Institute

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Estimate)

March 28, 2008

Last Update Submitted That Met QC Criteria

March 27, 2008

Last Verified

August 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUD 6/025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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