Combination Antimalarials in Uncomplicated Malaria
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ClinicalTrials.gov Identifier: NCT00203801 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : October 19, 2018
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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: | Open Label Study to Evaluate Combination Anti-malarial Therapy,in Terms of Efficacy, Prevalence of Gametocyte Carriage and Molecular Markers Associated With Sulfadoxine Pyrimethamine Resistance in Uncomplicated Plasmodium Falciparum |
Study Start Date : | January 2002 |
Actual Primary Completion Date : | July 2005 |
Actual 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 glutamate-rich protein (GLURP) and merozoite surface protein (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 dihydropteroate synthase (DHFR) and dihydrofolate reductase (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, Older Adult) |
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 37.5 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 Glucose-6-phosphate dehydrogenase (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 |
Responsible Party: | Professor Karen I Barnes, University of Cape Town |
ClinicalTrials.gov Identifier: | NCT00203801 |
Other Study ID Numbers: |
SEACAT 01 Mono (Am 1,2,3,5,6) |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | October 19, 2018 |
Last Verified: | October 2018 |
Malaria Efficacy Pharmacokinetic Gametocyte |
Molecular markers Sulfadoxine-pyrimethamine Artesunate Artemisinin |
Malaria Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Artesunate Lumefantrine Artemether Pyrimethamine Sulfadoxine Artemether, Lumefantrine Drug Combination Fanasil, pyrimethamine drug combination Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antineoplastic Agents Antiviral Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |