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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Plasmodium Infections

Intervention / Treatment
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* Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS)
* Drug: primaquine (PQ) plus SP+AS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primaquine, malaria, subpatent parasitaemia, dry season, Plasmodium falciparum infection detected by PCR