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Completed

NCT Number: NCT00330902

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

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Key information

Conditions

Plasmodium Infections Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tropical Medicine Research Institute

Khartoum, Sudan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sulfadoxine-pyrimethamine (SP) plus artesunate (AS)

Drug

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

primaquine (PQ) plus SP+AS

Drug

single dose of primaquine on day 4

Primary outcomes

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

    Time frame: 14 days from start of treatment

Secondary outcomes

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

    Time frame: 14 days from start of treatment

  2. Packed Cell volume on days 7 and 14.

    Time frame: Over 14 days from start of treatment

Interested in participating?

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Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Tropical Medicine Research Institute
  • World Health Organization

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2004
First posted
May 29, 2006
Registry last updated
Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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