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ISRCTN
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ISRCTN16409445
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ClinicalTrials.gov identifier
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Public title
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Open-label randomised clinical trial of pharmacokinetics, efficacy, and tolerability of the fixed-dose artesunate/amodiaquine combination therapy versus both drugs administered separately for treatment of uncomplicated falciparum malaria in Kenya
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Scientific title
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Acronym
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N/A
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Serial number at source
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1199
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Study hypothesis
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1. To investigate pharmacokinetic parameters of the fixed-dose artesunate/amodiaquine (AS/AQ) combination in adults with comparison to separate administration of the two drugs using a population pharmacokinetic design
2. To measure the clinical and parasitological efficacy of the fixed-dose AS/AQ combination therapy
3. To measure the parasite reduction ratio at 48 hours of treatment, parasite and fever clearance rates, proportions of patients with gametocyte persistence during follow up
4. To evaluate the incidence of adverse events
5. To formulate recommendations and to enable the Kenyan Ministry of Health to make informed decisions about the possible need for updating of the current national antimalarial treatment guidelines
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Lay summary
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Ethics approval
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Received from the ethics committee of the Kenya Medical Research Institute on the 22nd May 2007.
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Study design
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Open-label randomised, single centre clinical trial.
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Countries of recruitment
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Kenya
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Disease/condition/study domain
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Uncomplicated falciparum malaria
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Participants - inclusion criteria
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1. Adults from 18 to 60 years of age; either gender
2. Presenting with acute uncomplicated falciparum malaria:
2.1. Oral temperature greater than 37.5°C, or
2.2. History of fever in the last 24 hours
3. Positive P. falciparum parasitaemia (greater than 1000 asexual parasites/µL)
4. Written informed consent
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Participants - exclusion criteria
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1. Any other concomitant febrile illness, e.g. upper respiratory tract infection or Ear, Nose and Throat (ENT) infection
2. Features of severe malaria
3. Mixed Plasmodium infection
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Anticipated start date
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09/07/2007
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Anticipated end date
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30/03/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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Patients will be equally randomised into the following treatment groups:
Group A: fixed-dose AS/AQ combination tablets (100 mg/270 mg), two tablets once daily for three consecutive days.
Group B: AS tablets (50 mg): four tablets once a day for three consecutive days, and AQ tablets (153 mg): four tablets once a day for three consecutive days.
Patients will be followed-up for 28 days, and the total follow-up for the study will be 9 months.
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Primary outcome measure(s)
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The primary objective of this study is to investigate the pharmacokinetic properties of fixed-dose combination AS/AQ. Blood sampling will be performed at predefined time points in both groups of patients. The evaluation of pharmacokinetics variables will take place over the three-day treatment and the entire follow-up off-treatment.
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Secondary outcome measure(s)
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1. Treatment outcomes: the classification of treatment outcomes will be based on an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest (2005) guidelines of World Health Organisation (WHO). Accordingly, all patients will be classified as having an Early Treatment Failure, a Late Clinical Failure, a Late Parasitological Failure, or an Adequate Clinical and Parasitological Response
2. Safety variables: the occurrence of any adverse event will be documented. All patients will be routinely asked about old symptoms and new symptoms emerging since previous visit during follow-up
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Sources of funding
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1. Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
2. The Netherlands Ministry of Foreign Affairs (DGIS) (The Netherlands)
3. Medecins Sans Frontieres (MSF) (International)
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Trial website
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Publications
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Contact name
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Dr
Bernhards
Ogutu
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Address
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Walter Reed Project
Centre for Clinical Research
KEMRI
P.O. Box 54
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City/town
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Kisumu
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Zip/Postcode
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-
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Country
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Kenya
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Sponsor
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Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
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Address
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15 Chemin Louis Dunant
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City/town
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Geneva
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Zip/Postcode
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CH-1202
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Country
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Switzerland
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Sponsor website:
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http://www.dndi.org/
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Date applied
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05/07/2007
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Last edited
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24/11/2008
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Date ISRCTN assigned
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21/08/2007
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