A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria
This study has been completed.
Sponsor:
University of Cape Town
Collaborators:
World Health Organization
Medical Research Council, South Africa
Information provided by:
University of Cape Town
ClinicalTrials.gov Identifier:
NCT00203814
First received: September 13, 2005
Last updated: November 15, 2006
Last verified: August 2005
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Purpose
The purpose of this study is to determine the efficacy of sulfadoxine-pyrimethamine plus artesunate versus sulfadoxine-pyrimethamine alone in 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, Randomised, Parallel Group in Vivo Drug Study to Evaluate Combination Anti-Malarial Therapy (CAT), Artesunate and Sulfadoxine-Pyrimethamine Versus Sulfadoxine-Pyrimethamine Alone, in Terms of Therapeutic Efficacy, Prevalence of Gametocyte Carriage and Prevalence of Molecular Markers Associated With SP Resistance In Uncomplicated Plasmodium Falciparum Infections. |
Resource links provided by NLM:
MedlinePlus related topics:
Malaria
Drug Information available for:
Pyrimethamine
U.S. FDA Resources
Further study details as provided by University of Cape Town:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- Association between study treatment and gametocyte carriage
- Pharmacokinetics by measurement of whole blood levels of Sulfadoxine and Pyrimethamine
- Correlation of the frequency of DHFR and DHPS mutations with parasitological outcome
- Tolerability by describing adverse events and changes in haematological parameters
- Capacity building by describing the training and development of study teams and their subsequent skills attained
| Estimated Enrollment: | 280 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | March 2005 |
Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In order to facilitate formulation of effective regional drug policies and to provide a database for decision-making on the implementation of combination therapy (CAT), it is essential that the in vivo response to CAT be investigated. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there is a comprehensive evaluation of the phased introduction of combination anti-malarial therapy in Mozambique. As a component of this evaluation, in selected Mozambique sites where intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (SP) with CAT (artesunate plus SP) will be conducted according to this protocol.
Eligibility| Ages Eligible for Study: | 12 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female, older than 12 months.
- Weight > 10 kg.
- Diagnoses of pure uncomplicated acute P. falciparum malaria parasitaemia of up to 500 000 asexual parasite/mcl blood with axillary temperature of greater than or equal to 37.5°C or history of fever (defined as within the previous 24 hours).
- Documented informed consent.
- Lives close enough to the study site for reliable follow up.
Exclusion Criteria:
- Has received anti-malarial treatment in the past 7 days.
- Is infected with other malarial species (such subjects may be excluded retrospectively from the analysis).
- 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) or other danger signs.
- Has received cotrimoxazole, trimethoprim, chloramphenicol, folate or tetracyclines (including doxycycline) in the past 7 days or is likely to require these during the study period.
- History of G6PD deficiency.
- 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. co-artemether).
- Serious underlying disease that in the opinion of the clinic team and/or Principal Investigator would make the patient unsuitable for the study in terms of their safety or study analysis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203814
Locations
| Mozambique | |
| Boane Clinic | |
| Boane, Maputo, Mozambique | |
| Magude Clinic | |
| Magude, Mozambique | |
Sponsors and Collaborators
University of Cape Town
World Health Organization
Medical Research Council, South Africa
Investigators
| 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: | NCT00203814 History of Changes |
| Other Study ID Numbers: | SEACAT 01a ASSP |
| 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 16, 2013