Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1199
Study information
Scientific title
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
Acronym
Study hypothesis
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
Ethics approval
Ethics committee of the Kenya Medical Research Institute, 22/05/2007
Study design
Open-label randomised single-centre clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Uncomplicated falciparum malaria
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Artesunate, amodiaquine
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
09/07/2007
Overall trial end date
30/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
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
Recruitment start date
09/07/2007
Recruitment end date
30/03/2008
Locations
Countries of recruitment
Kenya
Trial participating centre
Walter Reed Project
Kisumu
-
Kenya
Sponsor information
Organisation
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Sponsor details
15 Chemin Louis Dunant
Geneva
CH-1202
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministerie van Buitenlandse Zaken
Alternative name(s)
Dutch Ministry of Foreign Affairs, Ministry of Foreign Affairs, Ministry of Foreign Affairs of the Kingdom of the Netherlands
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Netherlands
Funder name
Medecins Sans Frontieres (MSF) (International)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20368402