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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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29 April 2013 |
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Main ID: |
PACTR201102000277177 |
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Date of registration:
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07/02/2011 |
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Primary sponsor: |
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Public title:
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SMAC Artesunate Follow-Up Study
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Scientific title:
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Comparative, Open Label, Dose and Regimen Optimization Follow-up Study of Intravenous and Intramuscular Artesunate in African Children With Severe Malaria |
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Date of first enrolment:
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2011-07-04 |
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Target sample size:
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1046 |
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Recruitment status: |
Closed to recruitment: follow up continuing |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201102000277177 |
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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,
Simple randomisation using a randomisation table created by a computer software program,
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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Peter
Kremsner |
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Address:
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Wilhelmstrasse 27
72074
Tuebingen
Germany |
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Telephone:
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+4970712987179 |
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Email:
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peter.kremsner@uni-tuebingen.de |
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Affiliation:
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Coordinating Investigator |
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Name:
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Stefanie
Bolte |
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Address:
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Wilhelmstrasse 27
72074
Tuebingen
Germany |
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Telephone:
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+4970712982191 |
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Email:
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stefanie.bolte@uni-tuebingen.de |
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Affiliation:
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Project Manager |
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Key inclusion & exclusion criteria
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Inclusion criteria: Male or female children from 6 months to 10 years.
Clinical diagnosis of severe Plasmodium falciparum malaria requiring hospitalization.
Parasitaemia (b5000 parasites per microliter on initial blood smear).
Availability of child's parent/guardian and their willingness to provide written informed consent in accordance with the local practice.
Willingness and ability to comply with the study protocol for the duration of the study.
Willingness to remain in the hospital for 3 days.
Exclusion criteria: Known serious adverse reaction or hypersensitivity to artemisinins, including artemether, dihydroartemisinins or co-artemether (artemether/lumefantrine).
Any underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication.
Participation in any investigational drug study during 30 days prior to screening.
Adequate (according to WHO- and country specific guidelines) antimalarial treatment within 24 hours prior to admission.
Age minimum:
6 Month
Age maximum:
10 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
null
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Primary Outcome(s)
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The proportion of patients with parasite clearance (b99% reduction from Baseline) at 24hrs after initiation of study drug
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Secondary Outcome(s)
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genetic polymorphisms
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in vitro drug sensitivity
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non-invasive oto-acoustic test
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Pharmacokinetic sample collection for subgroup of 300 patients
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Source(s) of Monetary Support
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Bundesministerium f?r Bildung und Forschung
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European and Developing Countries Clinical Trials Partnership
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