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

Primary Purpose

Plasmodium Falciparum, Asymptomatic Parataemia, Sub Patent Parasitaemia

Status
Completed
Phase
Phase 3
Locations
Sudan
Study Type
Interventional
Intervention
Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)
placebo tablet similar to active drug in shape and size
Sponsored by
Tropical Medicine Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasmodium Falciparum

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All residents of the 8 villages

Exclusion Criteria:

  • Pregnancy
  • History of allergy to sulfa drugs

Sites / Locations

  • Tropical Medicine Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

1:Active comparator sulfadoxine-pyrimethamine plus artesunate

2:placebo comparator

Outcomes

Primary Outcome Measures

Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2008
Last Updated
March 27, 2008
Sponsor
Tropical Medicine Research Institute
Collaborators
London School of Hygiene and Tropical Medicine, International Atomic Energy Agency
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1. Study Identification

Unique Protocol Identification Number
NCT00646126
Brief Title
Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission
Official Title
Validation of the Use of Istope-Based Molecular Techniques for Malaria Control
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tropical Medicine Research Institute
Collaborators
London School of Hygiene and Tropical Medicine, International Atomic Energy Agency

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Falciparum, Asymptomatic Parataemia, Sub Patent Parasitaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
1:Active comparator sulfadoxine-pyrimethamine plus artesunate
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
2:placebo comparator
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)
Intervention Description
Standard three day regimen
Intervention Type
Drug
Intervention Name(s)
placebo tablet similar to active drug in shape and size
Intervention Description
Dosage similar to active drug(standard three days regimen)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
1. Malaria prevalence during the transmission season 2. Frequency of mutation in drug resistance genes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All residents of the 8 villages Exclusion Criteria: Pregnancy History of allergy to sulfa drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badria B El Sayed, PhD,MSc,BSc
Organizational Affiliation
Tropical Medicine Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tropical Medicine Research Institute
City
Khartoum
ZIP/Postal Code
11111
Country
Sudan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34585740
Citation
Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.
Results Reference
derived

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

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