Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan
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
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2004
Shorter than P25 for phase_3
1 active site
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
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 25, 2006
CompletedFirst Posted
Study publicly available on registry
May 29, 2006
CompletedOctober 31, 2007
October 1, 2007
May 25, 2006
October 30, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
P.falciparum parasitaemia detected by PCR on days 3,7 and 14.
14 days from start of treatment
Secondary Outcomes (2)
Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.
14 days from start of treatment
Packed Cell volume on days 7 and 14.
Over 14 days from start of treatment
Study Arms (2)
1
ACTIVE COMPARATORSulfadoxine pyrimethamine plus three daily doses of artesunate
2
EXPERIMENTALSulfadoxine pyrimethamine plus artesunate plus primaquine
Interventions
sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)
Eligibility Criteria
You may qualify if:
- infection with P.falciparum detected by PCR
You may not qualify if:
- pregnancy
- severe anaemia
- fever or other signs of illness
- history of allergy to sulfa drugs
- presence of other species of Plasmodium detected by microscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- Tropical Medicine Research Institutecollaborator
- World Health Organizationcollaborator
Study Sites (1)
Tropical Medicine Research Institute
Khartoum, Sudan
Related Publications (1)
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.
PMID: 18074034DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Badria B El Sayed, PhD
TMRI, Khartoum
- STUDY CHAIR
Omer Z Baraka, MD
Faculty of Medicine, University of Khartoum
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 25, 2006
First Posted
May 29, 2006
Study Start
January 1, 2004
Study Completion
November 1, 2004
Last Updated
October 31, 2007
Record last verified: 2007-10