NCT00646126

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

March 28, 2008

Status Verified

August 1, 2005

First QC Date

March 25, 2008

Last Update Submit

March 27, 2008

Conditions

Plasmodium FalciparumAsymptomatic ParataemiaSub Patent Parasitaemia

Outcome Measures

Primary Outcomes (1)

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

    October to December 2006

Secondary Outcomes (1)

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

Study Arms (2)

1

ACTIVE COMPARATOR

1:Active comparator sulfadoxine-pyrimethamine plus artesunate

Drug: Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)

2

PLACEBO COMPARATOR

2:placebo comparator

Drug: placebo tablet similar to active drug in shape and size

Interventions

Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)DRUG

Standard three day regimen

1
placebo tablet similar to active drug in shape and sizeDRUG

Dosage similar to active drug(standard three days regimen)

2

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All residents of the 8 villages

You may not qualify if:

  • Pregnancy
  • History of allergy to sulfa drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical Medicine Research Institute

Khartoum, Khartoum State, 11111, Sudan

Location

Related Publications (1)

  • 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.

    PMID: 34585740DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

SulfadoxinePyrimethamine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Badria B El Sayed, PhD,MSc,BSc

    Tropical Medicine Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

August 1, 2005

Last Updated

March 28, 2008

Record last verified: 2005-08

Locations

SU(1)