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

Plasmodium Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330902
• Other study ID #: SGS64
• Status: Completed
• Phase: Phase 3
• First received: May 25, 2006
• Last updated: October 30, 2007
• Start date: January 2004
• Est. completion date: November 2004

Study information

• Verified date: October 2007
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sudan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Malaria
• Plasmodium Infections

Intervention

Drug:
• sulfadoxine-pyrimethamine (SP) plus artesunate (AS)
sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)
• primaquine (PQ) plus SP+AS
single dose of primaquine on day 4

Locations

Country	Name	City	State
Sudan	Tropical Medicine Research Institute	Khartoum

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Tropical Medicine Research Institute, World Health Organization

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P.falciparum parasitaemia detected by PCR on days 3,7 and 14.		14 days from start of treatment
Secondary	Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.		14 days from start of treatment
Secondary	Packed Cell volume on days 7 and 14.		Over 14 days from start of treatment