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Main
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Note: This record shows only the 20 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. |
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Register:
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PACTR |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
PACTR2010020001862624 |
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Date of registration:
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21/01/2010 |
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Primary sponsor: |
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Public title:
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ACT IN PREGNANT WOMEN
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Scientific title:
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Comparison of the safety, efficacy and tolerability of artemether?-lumefantrine and artesunate amodiaquine in Nigerian pregnant women with acute uncomplicated falciparum malaria |
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Date of first enrolment:
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Target sample size:
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010020001862624 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
permuted block randomisation in blocks of 10,
sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Marcel
Ukah |
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Address:
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Dept. of Obs & Gynae OAUTHC Ile-Ife
220282
Ile-Ife
Nigeria |
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Telephone:
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+2347030497456 |
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Email:
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panyvinous@yahoo.com |
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Affiliation:
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Name:
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Marcel
Ukah |
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Address:
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Dept. of Obs & Gynae OAUTHC Ile-Ife
220282
Ile-Ife
Nigeria |
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Telephone:
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+2347030497456 |
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Email:
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panyvinous@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: a)Microscopically-confirmed P. falciparum malaria with parasitaemia of atleast one plus(1-10 parasites /100 thick film field).
b)Fever (T of 37.50C) or a history of fever,headaches,body pains within 24 hours of presentation
c)Ability to give informed consent
d)Willingness/ability to comply with follow up visits.
Exclusion criteria: a)Severe malaria or danger signs of severe malaria (e.g. loss of consciousness, convulsions, anuria)
b)Women in the first 13 weeks of pregnancy i.e. 1st trimester
c)Use of any anti-malarial drug other than sulphadoxine pyrimethamine less than 7 days before presentation
d)Other chronic illness e.g. hypertension, sickle cell.
e)Other pregnancy related diseases e.g. eclampsia, antepartum hemorrhage
f)History of reaction to any of the study drugs
g)Patients not tolerating orally.
Age minimum:
18 Year
Age maximum:
55 Year
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Malaria
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Primary Outcome(s)
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To assess the efficacy, safety and tolerability of Artesunate-Amodiaquine fixed dose combination compared to the Artemether-Lumefantrine fixed dose combination in the treatment of acute uncomplicated P. falciparum malaria in pregnancy.
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Secondary Outcome(s)
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Describe the pregnancy outcome in these women
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Secondary ID(s)
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ERC/2012/12/09
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Source(s) of Monetary Support
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Research grant Obafemi Awolowo University Teaching Hospitals Complex
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