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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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24 April 2017 |
Main ID: |
ISRCTN40020296 |
Date of registration:
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09/10/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia
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Scientific title:
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A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia |
Date of first enrolment:
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29/09/2008 |
Target sample size:
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1000 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN40020296 |
Study type:
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Interventional |
Study design:
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Randomised single-blind two-armed single-centre comparative study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Liberia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Richard
Smith |
Address:
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Saclepea CHC
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Nimba county
Liberia |
Telephone:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged greater than or equal to 6 years, either sex 2. Weight greater than or equal to 18 kg 3. Symptoms of malaria defined as fever (axillary temperature greater than or equal to 37.5°C), or history of fever in previous 48 hours 4. Microscopic confirmation of asexual stages of P. falciparum or mixed infection 5. Willingness to attend for follow-up 6. Signed informed consent by patient or responsible caregiver
Exclusion criteria: 1. Pregnancy (pregnancy test to be performed in women of childbearing age) 2. Severe malaria 3. AS-AQ or AL treatment at appropriate dose or more than two doses of another antimalarial in the previous 4 weeks 4. Known hypersensitivity to artemisinin derivates or amodiaquine, or artemether-lumefantrine 5. Severe anaemia (less than 5 g/dl haemoglobin) 6. Concomitant febrile illness if additional medication is required other than antipyretics
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria Infections and Infestations Plasmodium falciparum malaria
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Intervention(s)
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Patients will be equally randomised into the following treatment groups: 1. Artesunate-amodiaquine (AS-AQ Winthrop®, Sanofi-Aventis): tablet strength AS/AQ 100/270 mg. Participants will be dosed according to body weight: 18 - 35.9 kg = 1 x 100/270 mg tablet once daily Greater than 36 kg = 2 x 100/270 mg tablets once daily 2. Artemether-lumefantrine (Coartem, Novartis): tablet strength A/L 20/120 mg. Participants will be dosed according to body weight: 15 - 24.9 kg = 2 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages 25 - 34.9 kg = 3 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages Greater than 35 kg = 4 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages
For both arms: 3 days of treatment + 25 follow-up days (study duration/patient = 28 days).
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Primary Outcome(s)
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To describe clinical tolerability of a fixed dose of AS-AQ (Winthrop® FDC) in adults and children over 6 years with uncomplicated P. falciparum malaria compared to a non-AQ containing reference therapy, i.e. artemether-lumefantrine. The clinical tolerability will be defined as the occurrence of most common adverse events.
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Secondary Outcome(s)
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1. To describe serious adverse and drug related adverse events occurring within 1 month of drug administration for both treatment 2. To assess efficacy of treatment at 28 days (polymerase chain reaction [PCR] genotyping corrected) 3. To describe day 0 and day 7 blood levels of desethyl-amodiaquine and lumefantrine
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Source(s) of Monetary Support
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Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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