Combination Antimalarials in Uncomplicated Malaria
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ClinicalTrials.gov Identifier: NCT00203801 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: September 11, 2006
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malaria | Drug: Sulfadoxine-pyrimethamine Drug: Artesunate plus sulfadoxine-pyrimethamine Drug: Artemether-lumefantrine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 700 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label In Vivo Drug Study to Evaluate Combination Anti-Malarial Therapy (CAT),in Terms of Therapeutic Efficacy, Prevalence of Gametocyte Carriage and Prevalence of Molecular Markers Associated With SP Resistance in Uncomplicated Plasmodium Falciparum Infections. |
Study Start Date : | January 2002 |
Study Completion Date : | July 2005 |

- Therapeutic efficacy defined as:
- Adequate Clinical and Parasitological Response (ACPR), Early Treatment Failure (ETF), Late Treatment Failure (LTF), defined as Late Clinical Failure (LCF) and Late Parasitological Failure (LPF);
- Sensitive or parasitological failure (RI, early and late, RII, RIII)
- Parasitological failures will be classified as recrudescence or re-infection (or indeterminate) using GLURP and MSP I & II markers;
- Parasite clearance time;
- Fever clearance time.
- Association between study treatment and gametocyte carriage
- Pharmacokinetics by measurement of whole blood levels of Sulfadoxine and Pyrimethamine, and lumefantrine should a reliable assay become available
- Correlation of frequency of DHFR and DHPS mutations with parasitological outcome
- Tolerability by describing adverse events and changes in haematological parameters
- Capacity by describing the training and development of study teams and their subsequent skills attained

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Ages Eligible for Study: | 12 Months and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, older than 12 months.
- Weight > 10 kg.
- Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia of up to 250 000 asexual parasite/mcl blood with axillary temperature of greater than and equal to 37.50C or history of fever
- Documented informed consent
- Lives close enough to the health centre for reliable follow up
Exclusion Criteria:
- Has received anti-malarial treatment in the past 7 days.
- Severely ill (based on WHO Criteria for severe malaria ) or if patient is considered, in the opinion of the investigator or designee, to have moderately severe malaria (e.g. prostrate, repeated vomiting, dehydrated).
- Has received cotrimoxazole or chloramphenicol in the past 7 days.
- History of G6PD deficiency (not a contra-indication for artemether-lumefantrine).
- Is pregnant or breastfeeding.
- Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole, other artemisinin derivatives e.g. artemether-lumefantrine).

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): NCT00203801
Mozambique | |
Bela Vista Clinic | |
Bela Vista, Matutuine, Mozambique | |
Namaacha Clinic | |
Namaacha, Mozambique | |
South Africa | |
Ndumo Clinic | |
Ndumo, KwaZulu Natal, South Africa | |
Lulekani Clinic | |
Lulekani, Limpopo, South Africa | |
Naas Clinic | |
Naas, Mpumalanga, South Africa | |
Swaziland | |
Ndzevane Clinic | |
Ndzevane, Swaziland | |
Vuvulane Clinic | |
Vuvulane, Swaziland |
Principal Investigator: | Karen Barnes, MBChB | University of Cape Town |
ClinicalTrials.gov Identifier: | NCT00203801 History of Changes |
Other Study ID Numbers: |
SEACAT 01 Mono (Am 1,2,3,5,6) |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | September 11, 2006 |
Last Verified: | August 2005 |
Keywords provided by University of Cape Town:
Malaria Efficacy Pharmacokinetic Gametocyte |
Molecular markers Sulfadoxine-pyrimethamine Artesunate Artemisinin |
Additional relevant MeSH terms:
Malaria Protozoan Infections Parasitic Diseases Artesunate Lumefantrine Artemether Pyrimethamine Sulfadoxine Artemether-lumefantrine combination Artemisinins Fanasil, pyrimethamine drug combination Amebicides Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Antimalarials Antifungal Agents Coccidiostats Schistosomicides Antiplatyhelmintic Agents Anthelmintics Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |