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: pactr.samrc.ac.za
Trial no.: PACTR2009010000911750 Date of Approval: 24/04/2009
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/08/2007
Actual trial start date 19/06/2009
Anticipated date of last follow up 29/08/2008
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 4116
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NCT00393679 Cilicaltrials.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)
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-Treatment of Control Group
Experimental Group dihydroartemisinin-piperaquine 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively. 3 days treatment 1700 Active-Treatment of Control Group
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-Treatment of Control Group
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-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 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 16/10/2006 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
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
Uganda Malaria Surveillance Project Mulago Hospital Complex, PO Box 7475 Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP 334 Laan van Nieuw Oost Indië The Hague 2593 CE Netherlands
EDCTP 334 Laan van Nieuw Oost Indië The Hague 2593 CE Netherlands
MMV 20, route de Pré-Bois, Geneva 15 1215 Switzerland
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
Modest Mulenga TDRC Ndola Zambia
Modest Mulenga TDRC Ndola Zambia
Caroline Nabasumba Epicentre Mbarara Mbarara Uganda
Caroline Nabasumba Epicentre Mbarara Mbarara Uganda
Moses Kamya UMSP Kampala Uganda
Moses Kamya UMSP Kampala Uganda
Adoke Yeka UMSP Kampala Uganda
Adoke Yeka UMSP Kampala Uganda
Patrice Piola Epicentre Mbarara Mbarara Uganda
Patrice Piola Epicentre Mbarara Mbarara Uganda
Corine Karema PNLIP Kigali Rwanda
Corine Karema PNLIP Kigali Rwanda
Martin Meremikwu Calabar University Calabar Nigeria
Martin Meremikwu Calabar University Calabar Nigeria
Sonia Machevo Manhiça Health research Centre Manhiça Mozambique
Sonia Machevo Manhiça Health research Centre Manhiça Mozambique
Raquel Gonzales Manhiça health Research Centre Manhiça Mozambique
Raquel Gonzales Manhiça health Research Centre Manhiça Mozambique
Ghyslain Mombo-Ngoma Albert Schweitzer Hospital Lambarene Gabon
Ghyslain Mombo-Ngoma Albert Schweitzer Hospital Lambarene Gabon
Quique Bassat Manhiça Health Research Centre Manhiça Mozambique
Quique Bassat Manhiça Health Research Centre Manhiça Mozambique
Halidou Tinto Centre Muraz Bobo Dioulasso Burkina Faso
Halidou Tinto Centre Muraz Bobo Dioulasso Burkina Faso
Paula Williamson Liverpool University Liverpool United Kingdom
Paula Williamson Liverpool University Liverpool United Kingdom
Clara Menendez Fundació Clínic per la Recerca Biomèdica, Hospital Clinic of Barcelona Barcelona Spain
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
Bertrand Lell Institute of Tropical Medicine, University of Tübingen Tübingen Germany
Philippe Guerin Epicentre Paris France
Philippe Guerin Epicentre Paris France
Ambrose Talisuna Institute Tropical Medicine Antwerp Belgium
Ambrose Talisuna Institute Tropical Medicine Antwerp Belgium
Raffaella Ravinetto Institute Tropical Medicine Antwerp Belgium
Raffaella Ravinetto Institute Tropical Medicine Antwerp Belgium
Jean Pierre Van geertruyden Institute Tropical Medicine Antwerp Belgium
Jean Pierre Van geertruyden Institute Tropical Medicine Antwerp Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Umberto D'Alessandro udalessandro@itg.be 32 3 247 63 54 Nationalestraat 155
City Postal code Country Position/Affiliation
Antwerp 2000 Belgium Prof
Role Name Email Phone Street address
Public Enquiries Raffaella Ravinetto rravinetto@itg.be 32 3 247 6625 Nationalestraat 155
City Postal code Country Position/Affiliation
Antwerp 2000 Belgium Head Clinical Trial Unit
Role Name Email Phone Street address
Scientific Enquiries Maaike De Crop mdecrop@itg.be 32 3 247 67 16 Nationalestraat 155
City Postal code Country Position/Affiliation
Antwerp 2000 Belgium Trial Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes None Study Protocol None None
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/08/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/08/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 23/10/2024 Updated 28 Oct 2024
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 23/10/2024 Update Control Group, None, None, None, None, 0, Active-Treatment of Control Group