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.: PACTR201905610589889 Date of Approval: 21/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and efficacy of artesunate-amodiaquine for the treatment of uncomplicated malaria in Burundi
Official scientific title Safety and efficacy of artesunate-amodiaquine in four sentinel sites in Burundi for the treatment of uncomplicated malaria
Brief summary describing the background and objectives of the trial The first line treatment for uncomplicated malaria in Burundi is artesunate-amodiaquine. The last study evaluating the efficacy of artesunate-amodiaquine was conducted in 2015-2016 and the efficacy was 92,5%. This current planned study is a follow-up of routine surveillance of the first line treatment of malaria in the country. The mains objectives are to evaluate the safety and the efficacy of artesunate-amodiaquine in four sentinel sites Buhiga, Kazirabageni, Kigobe, and Mutoyi. The study will be conducted in the main group at risk, chidren between 6 months and 10 years.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TET
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 15/04/2019
Actual trial start date 19/04/2019
Anticipated date of last follow up 15/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 352
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Evaluation de l efficacite et de l innocute des antipaludiques Single dose 12 mg/kg of artesunate and 30 mg of amodiaquine 3 days il s agit d 'une étude d'évaluer l'efficacité des antipaludiques chez les enfants de 6 mois à 10 ans au quatre sites sentinelle du Burundi 352
Control Group There is no control group in a phse IV There is no control group in a phase IV There is no control group in a phase IV There is no control group in a phase IV 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 6 and 120 months (6 months and 10 years). Mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection). Parasitemia of 1000 - 200.000 parasites/μl. Presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h Ability to swallow oral medication. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule. Informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority. Pesence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO. Mixed or mono-infection with another Plasmodium species detected by microscopy. Presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score, or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm). Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) 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). Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 10 Year(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 19/10/2018 Comite National d Ethique
Ethics Committee Address
Street address City Postal code Country
Boulevard du 28 Novembre n 2 Bujumbura 1020 Burundi
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 21/11/2018 WHO Ethical Research Committee
Ethics Committee Address
Street address City Postal code Country
20 av Appia Geneva Geneva 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Early treatment failure • danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia; • parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature; • parasitaemia on day 3 with axillary temperature ≥ 37.5 ºC; • parasitaemia on day 3 ≥ 25% of count on day 0. Late treatment failure Late clinical failure • danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 in patients who did not previously meet any of the criteria of early treatment failure; • presence of parasitaemia on any day between day 4 and day 28 with axillary temperature ≥ 37.5 ºC or history of fever in patients who did not previously meet any of the criteria of early treatment failure. Late parasitological failure • presence of parasitaemia on any day between day 7 and day 28 with axillary temperature < 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure. Adequate clinical and parasitological response • absence of parasitaemia on day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure. 28 days
Secondary Outcome To determine the polymorphism of molecular markers for antimalarial drug(s) resistance; K13, pfmdr1, dhfr et dhps. Day 0 at inclusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de sante de Buhiga district de Buhiga, Province Karusi commune de Buhiga Burundi
Centre de sante de Kazibageni district de Nyanza Lac, Province Makamba commune de Nyanza La Burundi
Centre de sante de Kigobe district de Bujumbura Mairie Nord, province de Bujumbura Mairie commune de Ntahangwa Burundi
Centre de sante de Mutoyi district de Mutaho, Province de Gitega commune de Bugendana Burundi
FUNDING SOURCES
Name of source Street address City Postal code Country
WHO 20 av appia Geneva 1211 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ministere de la Sante Publique Avenue de lhopital Bujumbura Burundi None
COLLABORATORS
Name Street address City Postal code Country
OMS ROHERO 1 BUJUMBURA Burundi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ndayikunda Claudette ndaclau@yahoo.fr +25779663880 Kinanaira 4 avenue King David
City Postal code Country Position/Affiliation
Bujumbura 1020 Burundi Senior Lecture
Role Name Email Phone Street address
Scientific Enquiries Ringwald Pascal ringwaldp@who.int +41227913469 20 av appia
City Postal code Country Position/Affiliation
Geneva 1211 Switzerland Coordinatoor
Role Name Email Phone Street address
Public Enquiries Baza Bismas bazad@who.int +25779663880 Boulevard du 28 Novembre
City Postal code Country Position/Affiliation
Bujumbura Burundi Medical officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be entered in WHO excel software and will be share on requiement. Analysed data will be availbale on WHO website. Study Protocol Within 12 months Request to country and WHO and sign a data agreeemnt sharing
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.who.int/malaria/areas/drug_resistance/en/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information