A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria
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Purpose
The purpose of this study is to compare the efficacy of sulfadoxine-pyrimethamine plus artesunate with that of sulfadoxine-pyrimethamine on its own for the treatment of uncomplicated malaria.
| Condition | Intervention |
|---|---|
|
Malaria |
Drug: Sulfadoxine-pyrimethamine Drug: Artesunate plus sulfadoxine-pyrimethamine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label Drug Study (With Single and Parallel Group Components) to Evaluate Combination Antimalarial Therapy for Efficacy, Gametocyte Carriage and 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
- 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
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | October 2003 |
Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to malaria control. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there is an evaluation of the phased introduction of combination anti-malarial therapy (CAT) in Mozambique, Swaziland and South Africa. In order to facilitate formulation of effective regional drug policy and provide a database for decision-making on the implementation of CAT, it is essential that the in vivo response to CAT be investigated. This will be achieved through the SEACAT 01 protocol which is a component of the SEACAT evaluation described in another file on this website. However, in selected Mozambique sites where the intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (SP) with CAT (artesunate, AS, plus SP) will be conducted according to a specific amendment (Amendment 4) to the SEACAT 01 protocol. Amendment 4 is presented in this separate file on the website for clarity.
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 500 000 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.
- Is infected with other malarial species (such subjects will be excluded retrospectively).
- 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.
- Is pregnant.
- Has a history of allergy to any sulphonamide (for SP) or artemisinin derivative (for artesunate and co-artemether).
Contacts and Locations| Mozambique | |
| Catuane Clinic | |
| Catuane, Matutuine, Mozambique | |
| Namaacha Clinic | |
| Namaacha, Mozambique | |
| Principal Investigator: | Karen Barnes, MBChB | University of Cape Town |
More Information
No publications provided by University of Cape Town
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00203736 History of Changes |
| Other Study ID Numbers: | SEACAT 01 Am 4 (RCT) |
| Study First Received: | September 13, 2005 |
| Last Updated: | November 15, 2006 |
| Health Authority: | Mozambique: Ministry of Health (MISAU) |
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 Artesunate Sulfadoxine-pyrimethamine 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 Amebicides |
ClinicalTrials.gov processed this record on May 19, 2013