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

October 30, 2007 updated by: London School of Hygiene and Tropical Medicine

Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

104

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
        • 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

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Sulfadoxine pyrimethamine plus three daily doses of artesunate
Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS)
sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)
Experimental: 2
Sulfadoxine pyrimethamine plus artesunate plus primaquine
Drug: primaquine (PQ) plus SP+AS
single dose of primaquine on day 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
P.falciparum parasitaemia detected by PCR on days 3,7 and 14.
Time Frame: 14 days from start of treatment
14 days from start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.
Time Frame: 14 days from start of treatment
14 days from start of treatment
Packed Cell volume on days 7 and 14.
Time Frame: Over 14 days from start of treatment
Over 14 days from start of treatment

Collaborators and Investigators

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

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

World Health Organization
Tropical Medicine Research Institute

Investigators

  • Principal Investigator: Badria B El Sayed, PhD, TMRI, Khartoum
  • Study Chair: Omer Z Baraka, MD, Faculty of Medicine, University of Khartoum

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

January 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

May 25, 2006

First Submitted That Met QC Criteria

May 25, 2006

First Posted (Estimate)

May 29, 2006

Study Record Updates

Last Update Posted (Estimate)

October 31, 2007

Last Update Submitted That Met QC Criteria

October 30, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGS64

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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