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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.: PACTR2009010000911750 Date registered: 2008/11/10
TRIAL DESCRIPTION
Public title 4 ACT for uncomplicated malaria in African children
Official scientific title Evaluation of 4 Artemisinin-Based Combinations for Treating Uncomplicated Malaria in African Children
Brief summary describing the background
and objectives of the trial
The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations [amodiaquine-artesunate,dihydroartemisinin-piperaquine, artemether-lumefantrine and chlorproguanil/dapsone plus artesunate] for single and repeat treatments of uncomplicated malaria in children
Type of trial CCT
Acronym (If the trial has an acronym then please provide) 4ABC
Disease(s) or condition(s) being studied Malaria ,
Purpose of the trial Treatment
Anticipated trial start date
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 4000   
Recruitment status Closed to recruitment: follow up continuing
Secondary Ids Issuing authority/Trial register Links to Secondary ID
NCT00393679 Clinicaltrials. gov

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 Block randomisation of variable size. Sealed opaque envelopes Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group artemether-lumefantrine Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. 3 days treatment 1360 Active
Experimental group dihydroartemisinin-piperaquine 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively. 3 days treatment 1700 Active
Experimental group Chlorproguanil-dapsone-artesunate Lapdap will be administered orally at a dose of 2.0 mg/kg chlorproguanil and 2.5 mg/kg dapsone once daily 3 days treatment 1020 Active
Experimental group amodiaquine-artesunate between 2 and 10 mg/kg of artesunate and 7.5 to 15 mg/kg of amodiaquine once a day for 3 days 3 days treatment 1020 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1. Weight > 5 kg; 2. Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 asexual parasites per µl; 3. Fever (axillary temperature ³37.5 °C) or history of fever in the preceding 24 hours; 4. Haemoglobin value more or equal to 7.0 g/dl; 5. Signed informed consent by the parents or guardians; 6. Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial 1. Participation in any other investigational drug study (antimalarial or others) during the previous 30 days 2. Known hypersensitivity to the study drugs 3. Severe malaria 4. Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand; 5. Presence of intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency 6. Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference) 7. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women 0 null 4 nulls 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 2006/10/16 Comite voor Medische Ethiek, Universitair Ziekenhuis Antwerpen
Ethics Committee Address
Street address City Postal code Country
Wilrijkstraat 10 Edegem 2650 Belgium

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PCR adjusted treatment failure up to day 28 (TF28A): all early failures before day 14 plus the recurrent parasitaemias detected at day 14 or later and classified by genotyping as recrudescence Throughout the follow up
Primary Outcome PCR unadjusted treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping Day 28

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Uganda Malaria Surveillance Project Mulago Hospital Complex, PO Box 7475 Kampala Uganda
The Tropical Diseases Research Centre PO Box 71769 Ndola Zambia
The National Malaria Control Programme Rwanda BP 2514 Kigali Rwanda
Mbarara University of Science and Technology Mbarara Uganda
Centre Muraz 01 BP 390, Bobo Dioulasso 01 Burkina Faso
Institute for Tropical Diseases Research & Prevention, University of Calabar Teaching Hospital Moore Road PMB 1278 GP, Calabar Nigeria
Hospital Albert Schweitzer, BP 118, Lambarene, Gabon
Manhica Health Research Centre Manhiça Mozambique

FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP 334 Laan van Nieuw Oost Indië The Hague 2593 CE Netherlands
MMV 20, route de Pré-Bois, Geneva 15 1215 Switzerland
EDCTP 334 Laan van Nieuw Oost Indië The Hague 2593 CE Netherlands
MMV 20, route de Pré-Bois, Geneva 15 1215 Switzerland

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institute Tropical Medicine Nationalestraat 155 Antwerp 2000 Belgium University
Primary Sponsor Institute Tropical Medicine Nationalestraat 155 Antwerp 2000 Belgium University

COLLABORATORS
Name Street address City Postal code Country
Moses Kamya UMSP Kampala Uganda
Adoke Yeka UMSP Kampala Uganda
Patrice Piola Epicentre Mbarara Mbarara Uganda
Corine Karema PNLIP Kigali Rwanda
Martin Meremikwu Calabar University Calabar Nigeria
Sonia Machevo Manhiça Health research Centre Manhiça Mozambique
Raquel Gonzales Manhiça health Research Centre Manhiça Mozambique
Ghyslain Mombo-Ngoma Albert Schweitzer Hospital Lambarene Gabon
Quique Bassat Manhiça Health Research Centre Manhiça Mozambique
Halidou Tinto Centre Muraz Bobo Dioulasso Burkina Faso
Paula Williamson Liverpool University Liverpool United Kingdom
Clara Menendez Fundació Clínic per la Recerca Biomèdica, Hospital Clinic of Barcelona Barcelona Spain
Bertrand Lell Institute of Tropical Medicine, University of Tübingen Tübingen Germany
Philippe Guerin Epicentre Paris France
Ambrose Talisuna Institute Tropical Medicine Antwerp Belgium
Raffaella Ravinetto Institute Tropical Medicine Antwerp Belgium
Jean Pierre Van geertruyden Institute Tropical Medicine Antwerp Belgium
Modest Mulenga TDRC Ndola Zambia
Caroline Nabasumba Epicentre Mbarara Mbarara Uganda
Moses Kamya UMSP Kampala Uganda
Adoke Yeka UMSP Kampala Uganda
Patrice Piola Epicentre Mbarara Mbarara Uganda
Corine Karema PNLIP Kigali Rwanda
Martin Meremikwu Calabar University Calabar Nigeria
Sonia Machevo Manhiça Health research Centre Manhiça Mozambique
Raquel Gonzales Manhiça health Research Centre Manhiça Mozambique
Ghyslain Mombo-Ngoma Albert Schweitzer Hospital Lambarene Gabon
Quique Bassat Manhiça Health Research Centre Manhiça Mozambique
Halidou Tinto Centre Muraz Bobo Dioulasso Burkina Faso
Paula Williamson Liverpool University Liverpool United Kingdom
Clara Menendez Fundació Clínic per la Recerca Biomèdica, Hospital Clinic of Barcelona Barcelona Spain
Bertrand Lell Institute of Tropical Medicine, University of Tübingen Tübingen Germany
Philippe Guerin Epicentre Paris France
Ambrose Talisuna Institute Tropical Medicine Antwerp Belgium
Raffaella Ravinetto Institute Tropical Medicine Antwerp Belgium
Jean Pierre Van geertruyden Institute Tropical Medicine Antwerp Belgium
Modest Mulenga TDRC Ndola Zambia
Caroline Nabasumba Epicentre Mbarara Mbarara Uganda

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Umberto D'Alessandro udalessandro@itg.be 32 3 247 63 54 32 3 247 63 59
Street address City Postal code Country Position / Affiliation
Nationalestraat 155 Antwerp 2000 Belgium Prof
Role Name Email Phone Fax
Scientific Enquiries Mrs Maaike De Crop mdecrop@itg.be 32 3 247 67 16
Street address City Postal code Country Position / Affiliation
Nationalestraat 155 Antwerp 2000 Belgium Trial Manager
Role Name Email Phone Fax
Public Enquiries Mrs Raffaella Ravinetto rravinetto@itg.be 32 3 247 6625
Street address City Postal code Country Position / Affiliation
Nationalestraat 155 Antwerp 2000 Belgium Head Clinical Trial Unit