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Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan

NCT ID: NCT00330902

Last Updated: 2007-10-31

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

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-11-30

Brief Summary

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In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.

Detailed Description

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104 individuals with low density Plasmodium falciparum infection detected by polymerase chain reaction (PCR) were randomized to receive sulfadoxine-pyrimethamine and three daily doses of artesunate (SP+AS) or SP+AS and a dose of primaquine (SP+AS+PQ), and were followed up for 14 days during the transmission-free season in Eastern Sudan. Subjects were visited on days 3, 7 and 14 after the start of treatment to record any adverse events and to detect P.falciparum using PCR. PCR positive samples were tested for gametocytes using RT-PCR. Packed cell volume was measured on days 7 and 14.

Conditions

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Plasmodium Infections

Keywords

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malaria subpatent parasitaemia dry season primaquine Plasmodium falciparum infection detected by PCR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Sulfadoxine pyrimethamine plus three daily doses of artesunate

Group Type ACTIVE_COMPARATOR

sulfadoxine-pyrimethamine (SP) plus artesunate (AS)

Intervention Type DRUG

sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)

2

Sulfadoxine pyrimethamine plus artesunate plus primaquine

Group Type EXPERIMENTAL

primaquine (PQ) plus SP+AS

Intervention Type DRUG

single dose of primaquine on day 4

Interventions

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sulfadoxine-pyrimethamine (SP) plus artesunate (AS)

sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)

Intervention Type DRUG

primaquine (PQ) plus SP+AS

single dose of primaquine on day 4

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* infection with P.falciparum detected by PCR

Exclusion Criteria

* pregnancy
* severe anaemia
* fever or other signs of illness
* history of allergy to sulfa drugs
* presence of other species of Plasmodium detected by microscopy
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tropical Medicine Research Institute

OTHER

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Badria B El Sayed, PhD

Role: PRINCIPAL_INVESTIGATOR

TMRI, Khartoum

Omer Z Baraka, MD

Role: STUDY_CHAIR

Faculty of Medicine, University of Khartoum

Locations

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Tropical Medicine Research Institute

Khartoum, , Sudan

Site Status

Countries

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Sudan

References

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El-Sayed B, El-Zaki SE, Babiker H, Gadalla N, Ageep T, Mansour F, Baraka O, Milligan P, Babiker A. A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan. PLoS One. 2007 Dec 12;2(12):e1311. doi: 10.1371/journal.pone.0001311.

Reference Type DERIVED
PMID: 18074034 (View on PubMed)

Other Identifiers

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SGS64

Identifier Type: -

Identifier Source: org_study_id