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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201102000277177 Date registered: 2011/02/07
TRIAL DESCRIPTION
Public title SMAC Artesunate Follow-Up Study
Official scientific title Comparative, Open Label, Dose and Regimen Optimization Follow-up Study of Intravenous and Intramuscular Artesunate in African Children With Severe Malaria
Brief summary describing the background
and objectives of the trial
This is a multi-centric, follow-up study to the dose regimen optimization phase II-trial that will compare 3-dose versus 5-dose regimen of intravenous or intramuscular application of Artesunate in children with severe Malaria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Malaria ,
Purpose of the trial Treatment
Anticipated trial start date 2011-05-01
Actual trial start date 2011-07-04
Anticipated date of last follow up 2012-09-24
Actual date of last follow up 2012-10-24
Anticipated target sample size (number of participants) 1044   
Actual target sample size (number of participants) 1046   
Recruitment status Closed to recruitment: follow up continuing
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
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 Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Artesunate 12mg/kg total dose 0h, 24h, 48h intravenous application 348
Experimental group Artesunate 12mg/kg total dose 0h, 24h, 48h intramuscular application 348
Control group Artesunate (standard treatment) 12mg/kg total dose 0h, 12h, 24h, 48h, 72h intramuscular application 348 Dose comparison

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Male or female children from 6 months to 10 years. Clinical diagnosis of severe Plasmodium falciparum malaria requiring hospitalization. Parasitaemia (>5000 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. 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. 6 Months 10 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2011/02/15 Comité dEthique Régional Independent de Lambaréné
Ethics Committee Address
Street address City Postal code Country
Mrs Mbili Christiane Lambaréné BP: 250 Gabon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2011/06/22 The Gambia Government/MRC Unit, The Gambia Joint - Ethics Committee
Ethics Committee Address
Street address City Postal code Country
c/o MRC Unit, The Gambia, Fajara, P.O Box 273 Banjul Gambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2011/04/13 School of Medical Sciences, Committee on Human research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
Kwame Nkrumah University of Science and Technology Kumasi Ghana

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of patients with parasite clearance (>99% reduction from Baseline) at 24hrs after initiation of study drug Blood smears will be performed every 6hrs or until 3 consecutive negative slides.
Secondary Outcome Pharmacokinetic sample collection for subgroup of 300 patients 3 times points per patient of subgroup between Day0 and Day2-3 depending on cohort
Secondary Outcome non-invasive oto-acoustic test Baseline 12hrs post initial dose discharge or recovery
Secondary Outcome LODS Baseline 24hrs post intial dose 48hrs post initial dose
Secondary Outcome genetic polymorphisms 3 times points per patient of subgroup between Day0 and Day2-3 depending on cohort
Secondary Outcome in vitro drug sensitivity Baseline (only in Gabon)

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Council Laboratories Chipatala Avenue Banjul Gambia
School of Medical Sciences at the University of Science and Technology Kumasi Ghana
Queen Elizabeth Central Hospital Chipatala Avenue Blantyre 3 Malawi
Kenya Medical Research Institute Mbagathi Rd Kilifi 80108 Kenya
Albert Schweitzer Hospital B.P.118 Lambaréné Gabon
Kondele Children¿s Hospital research unit-Kisumu Kisumu Kenya
Faculté de Médecine-Université des Sciences de la Santé (USS) Libreville Gabon

FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership Laan van Nieuw Oost Indië 334 The Hague 334 Netherlands
Bundesministerium für Bildung und Forschung Heinemannstr. 2 Bonn 53175 Bonn Germany

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Peter Kremsner Wilhelmstrasse 27 Tuebingen 72074 Germany Hospital

COLLABORATORS
Name Street address City Postal code Country
Prof. Schmutzhard Anichstrasse 35 Innsbruck 6020 Austria
Dr. R. Helbok Anichstrasse 35 Innsbruck 6020 Austria
Dr Reinhold Kerb, Dr Margarete Fischer-Bosch Institute of Clinical Pharmacology, Auerbachstrasse 112 Stuttgart 70376 Germany

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Peter Kremsner peter.kremsner@ uni-tuebingen.de +4970712987179 +497071295189
Street address City Postal code Country Position / Affiliation
Wilhelmstrasse 27 Tuebingen 72074 Germany Coordinating Investigator
Role Name Email Phone Fax
Public Enquiries Dr Stefanie Bolte stefanie.bolte@ uni-tuebingen.de +4970712982191 +4907071294684
Street address City Postal code Country Position / Affiliation
Wilhelmstrasse 27 Tuebingen 72074 Germany Project Manager
Role Name Email Phone Fax
Scientific Enquiries Prof Peter Kremsner peter.kremsner@ uni-tuebingen.de +4970712987179 +497071295189
Street address City Postal code Country Position / Affiliation
Wilhelmstrasse 27 Tuebingen 72074 Germany Coordinating Investigator