Combination Antimalarials in Uncomplicated Malaria
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Purpose
The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.
| Condition | Intervention |
|---|---|
|
Malaria |
Drug: Sulfadoxine-pyrimethamine Drug: Artesunate plus sulfadoxine-pyrimethamine Drug: Artemether-lumefantrine |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
- 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
| Estimated Enrollment: | 700 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | July 2005 |
The resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there will be a comprehensive evaluation of phased introduction of combination anti-malarials (CAT) in Mozambique, Swaziland and South Africa. In order to facilitate formulation of an effective regional drug policy and provide a database for decision-making on the implementation of combination therapy, it is essential that the in vivo response to CAT in all three countries be investigated. An SP therapeutic efficacy study will be conducted according to this modified WHO protocol to guide the selection of CAT. After CAT is introduced an in vivo CAT efficacy study will then be conducted to evaluate the efficacy of artesunate plus SP (or artemether-lumefantrine in KwaZulu Natal and Limpopo). In areas of low intensity malaria transmission the CAT in vivo study results will be compared across sites and with those found at baseline with monotherapy, for each site.
Eligibility| Ages Eligible for Study: | 12 Months and older |
| Genders Eligible for Study: | Both |
| 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).
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00203801 History of Changes |
| Other Study ID Numbers: | SEACAT 01 Mono (Am 1,2,3,5,6) |
| Study First Received: | August 29, 2005 |
| Last Updated: | September 7, 2006 |
| Health Authority: | South Africa: Medicines Control Council Mozambique: Ministry of Health Swaziland: Ministry of Health and Social Welfare |
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 Antimalarials Pyrimethamine Sulfadoxine Artemether Artesunate Sulfadoxine-pyrimethamine Lumefantrine Artemether-lumefantrine combination Artemisinins Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Antifungal Agents Coccidiostats Schistosomicides Antiplatyhelmintic Agents Anthelmintics Amebicides |
ClinicalTrials.gov processed this record on June 18, 2013