search
Back to results

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

Primary Purpose

Plasmodium Infections

Status
Completed
Phase
Phase 3
Locations
Sudan
Study Type
Interventional
Intervention
sulfadoxine-pyrimethamine (SP) plus artesunate (AS)
primaquine (PQ) plus SP+AS
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasmodium Infections focused on measuring malaria, subpatent parasitaemia, dry season, primaquine, Plasmodium falciparum infection detected by PCR

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tropical Medicine Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Sulfadoxine pyrimethamine plus three daily doses of artesunate

Sulfadoxine pyrimethamine plus artesunate plus primaquine

Outcomes

Primary Outcome Measures

P.falciparum parasitaemia detected by PCR on days 3,7 and 14.

Secondary Outcome Measures

Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.
Packed Cell volume on days 7 and 14.

Full Information

First Posted
May 25, 2006
Last Updated
October 30, 2007
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Tropical Medicine Research Institute, World Health Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT00330902
Brief Title
Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Tropical Medicine Research Institute, World Health Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Infections
Keywords
malaria, subpatent parasitaemia, dry season, primaquine, Plasmodium falciparum infection detected by PCR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Sulfadoxine pyrimethamine plus three daily doses of artesunate
Arm Title
2
Arm Type
Experimental
Arm Description
Sulfadoxine pyrimethamine plus artesunate plus primaquine
Intervention Type
Drug
Intervention Name(s)
sulfadoxine-pyrimethamine (SP) plus artesunate (AS)
Intervention Description
sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)
Intervention Type
Drug
Intervention Name(s)
primaquine (PQ) plus SP+AS
Intervention Description
single dose of primaquine on day 4
Primary Outcome Measure Information:
Title
P.falciparum parasitaemia detected by PCR on days 3,7 and 14.
Time Frame
14 days from start of treatment
Secondary Outcome Measure Information:
Title
Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.
Time Frame
14 days from start of treatment
Title
Packed Cell volume on days 7 and 14.
Time Frame
Over 14 days from start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badria B El Sayed, PhD
Organizational Affiliation
TMRI, Khartoum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Omer Z Baraka, MD
Organizational Affiliation
Faculty of Medicine, University of Khartoum
Official's Role
Study Chair
Facility Information:
Facility Name
Tropical Medicine Research Institute
City
Khartoum
Country
Sudan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18074034
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs