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

NCT ID: NCT00646126

Last Updated: 2008-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Plasmodium Falciparum Asymptomatic Parataemia Sub Patent Parasitaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

1:Active comparator sulfadoxine-pyrimethamine plus artesunate

Group Type ACTIVE_COMPARATOR

Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)

Intervention Type DRUG

Standard three day regimen

2

2:placebo comparator

Group Type PLACEBO_COMPARATOR

placebo tablet similar to active drug in shape and size

Intervention Type DRUG

Dosage similar to active drug(standard three days regimen)

Interventions

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Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)

Standard three day regimen

Intervention Type DRUG

placebo tablet similar to active drug in shape and size

Dosage similar to active drug(standard three days regimen)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All residents of the 8 villages

Exclusion Criteria

* Pregnancy
* History of allergy to sulfa drugs
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

International Atomic Energy Agency

OTHER_GOV

Sponsor Role collaborator

Tropical Medicine Research Institute

OTHER

Sponsor Role lead

Principal Investigators

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Badria B El Sayed, PhD,MSc,BSc

Role: PRINCIPAL_INVESTIGATOR

Tropical Medicine Research Institute

Locations

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Tropical Medicine Research Institute

Khartoum, Khartoum State, Sudan

Site Status

Countries

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Sudan

References

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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.

Reference Type DERIVED
PMID: 34585740 (View on PubMed)

Other Identifiers

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SUD 6/025

Identifier Type: -

Identifier Source: org_study_id