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.: PACTR201708002499311 Date of Approval: 03/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of antimalarials (Artemether/Lumefantrine and Dihydroartemisinine/Piperaquine) used in Burkina Faso for the treatment of malaria in children
Official scientific title Efficacy and safety of two artemisinin based combination therapies (CTAs) for the treatment of uncomplicated Plasmodium falciparum malaria in Burkina Faso
Brief summary describing the background and objectives of the trial Resistance to antimalarial drugs is a major public health problem, which hinders the control of malaria. In order to combat the growing resistance, a surveillance system is needed, which will facilitate monitoring and containment. The goal of the study is to provide to the National Malaria Control Program of Burkina Faso updated data on the efficacy and safety of ACTs recommended or used for the treatment of uncomplicated malaria in Burkina Faso for decision based on evidence. The trial objective is to assess the therapeutic efficacy and safety of three artemisinin based combination therapies for the treatment of uncomplicated P. falciparum malaria in children. The study antimalarials are the following: ¿ artemether-lumefantrine (AL), ¿ dihydroarteartemisinin-piperaquine (DHAPPQ). Safety will be assessed based on type and severity of adverse events and laboratory findings in addition to the observation of vital signs
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CNRFP TET2017001
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Other
Anticipated trial start date 11/09/2017
Actual trial start date 11/09/2017
Anticipated date of last follow up 12/02/2018
Actual Last follow-up date 12/02/2018
Anticipated target sample size (number of participants) 720
Actual target sample size (number of participants) 720
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Permuted block randomisation. 1:1 randomisation of 2 groups, blocks will be size 10 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 2 times per day 3 days Administration of tablets of artemether lumefantrine two times per day for three days 360
Experimental Group Dihydroartemisinine/piperaquine Once daily Three days Administration of tablets of Dihydroartemisinine/piperaquine one daily for three days 360
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age, 6¿59 months, Mono-infection with P. falciparum detected by microscopy; Asexual parasite count of 2000¿200 000/¿l Axillary temperature ¿ 37.5 °C or history of fever during the previous two weeks; Hemoglogin ¿ 8g/dl Ability to swallow oral medication; Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule; Informed consent from a parent or guardian in the case of children Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO Body weight less than 5 kg; Presence of severe malnutrition (defined as a child whose growth standard is below ¿3 z-score); Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea withdehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS); Regular medication, which may interfere with antimalarial pharmacokinetics; History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s) Known individual or familly history of clinically significant prolonged QTc or subite death Previous particpation to malaria vaccine trial 6 Month(s) 59 Month(s) 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 05/07/2017 Comité d'Ethique pour la Recherche en Santé (CERS)
Ethics Committee Address
Street address City Postal code Country
1200 logements Ouagadougou 01 Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adequate clinical and parasitological response at day 28 PCR-corrected. Day 28
Primary Outcome Late treatment failure From day 4 to day 28
Primary Outcome Early treatment failure From day 1 to day 3
Secondary Outcome Adequate clinical and parasitological response at day 42, PCR-corrected. Day 42
Secondary Outcome Fever clearance At any time
Secondary Outcome Parasite clearance At any time
Secondary Outcome Nature and incidence of adverse events At any time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre National de Recherche et de Formation sur le Paludisme (CNRFP) 1487 Avenue Kumda Yonré Ouagadougou 01 BP 2208 Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
Improving Malaria Care (IMC Project) Gounghin Ouagadougou 01 POB 5654 Burkina Faso
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Improving Malaria Care (IMC Project) Gounghin Ouagadougou 01 POB 5654 Burkina Faso Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Programme National de Lutte contre le Paludisme (PNLP) Avenue Kumda Yonré Ouagadougou Burkina Faso
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adama GANSANE agansane.cnrfp@fasonet.bf +22670233723 1487 Avenue Kumda Yonre
City Postal code Country Position/Affiliation
Ouagadougou 01 POB 2208 Burkina Faso Research and Training Coordinator
Role Name Email Phone Street address
Public Enquiries Ousmane Badolo Ousmane.Badolo@jhpiego.org +226 70 25 34 00 Gounghin
City Postal code Country Position/Affiliation
Ouagadougou 01 PO Box 5654 Burkina Faso
Role Name Email Phone Street address
Scientific Enquiries Innocent Valea i.valea.cnrfp@fasonet.bf +22662848484 1487 Avenue Kumda Yonre
City Postal code Country Position/Affiliation
Ouagadougou 01 POB 2208 Burkina Faso Study Director
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information