Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan
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| ClinicalTrials.gov Identifier: NCT00330902 |
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Recruitment Status :
Completed
First Posted : May 29, 2006
Last Update Posted : October 31, 2007
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Sponsor:
London School of Hygiene and Tropical Medicine
Collaborators:
Tropical Medicine Research Institute
World Health Organization
Information provided by:
London School of Hygiene and Tropical Medicine
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plasmodium Infections | Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS) Drug: primaquine (PQ) plus SP+AS | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 104 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | January 2004 |
| Actual Study Completion Date : | November 2004 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Sulfadoxine pyrimethamine plus three daily doses of artesunate
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Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS)
sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS) |
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Experimental: 2
Sulfadoxine pyrimethamine plus artesunate plus primaquine
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Drug: primaquine (PQ) plus SP+AS
single dose of primaquine on day 4 |
Primary Outcome Measures :
- P.falciparum parasitaemia detected by PCR on days 3,7 and 14. [ Time Frame: 14 days from start of treatment ]
Secondary Outcome Measures :
- Presence of gametocytes detected by RT-PCR on days 3, 7 and 14. [ Time Frame: 14 days from start of treatment ]
- Packed Cell volume on days 7 and 14. [ Time Frame: Over 14 days from start of treatment ]
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| Ages Eligible for Study: | 3 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330902
Locations
| Sudan | |
| Tropical Medicine Research Institute | |
| Khartoum, Sudan | |
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Tropical Medicine Research Institute
World Health Organization
Investigators
| Principal Investigator: | Badria B El Sayed, PhD | TMRI, Khartoum | |
| Study Chair: | Omer Z Baraka, MD | Faculty of Medicine, University of Khartoum |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00330902 History of Changes |
| Other Study ID Numbers: |
SGS64 |
| First Posted: | May 29, 2006 Key Record Dates |
| Last Update Posted: | October 31, 2007 |
| Last Verified: | October 2007 |
Keywords provided by London School of Hygiene and Tropical Medicine:
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malaria subpatent parasitaemia dry season primaquine Plasmodium falciparum infection detected by PCR |
Additional relevant MeSH terms:
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Infection Malaria Parasitemia Protozoan Infections Parasitic Diseases Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Artesunate Artemisinins Primaquine Pyrimethamine |
Sulfadoxine Fanasil, pyrimethamine drug combination Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |