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.: PACTR201803003018369 Date of Approval: 26/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Artemisinin based Combination therapy Trial
Official scientific title A Randomized Trial of Dihydroartemisinin-piperaquine (Malacur®) versus Artemether-lumefantrine (Coartem®) for Treatment of uncomplicated Plasmodium falciparum Malaria in Mali
Brief summary describing the background and objectives of the trial WHO recommended artemisinin-based combination therapies (ACTs) for uncomplicated malaria since 2006. Artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ) were chosen by the National Malaria Control Program to treat uncomplicated malaria in Mali. Many studies showed that AL and ASAQ remained efficacious against uncomplicated falciparum malaria in Mali and Africa and data on clinical efficacy, safety and tolerability of AL and ASAQ exists in Mali and Africa. Dihydroartemisinin-piperaquine (DHA-PQ) is also an ACT recommended by WHO for uncomplicated malaria in Africa but, few data are available on its clinical efficacy and safety. DHA-PQ is a potential alternative for the treatment of uncomplicated malaria in Mali. Therefore clinical efficacy and safety data on DHA-PQ are required before its use in Mali as recommended by WHO as an alternative choice. The aim of this study was to evaluate the in vivo efficacy and tolerability of the DHA-PQ compared to AL in the treatment of uncomplicated malaria in Mali.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 27/09/2013
Actual trial start date 27/09/2013
Anticipated date of last follow up 26/01/2016
Actual Last follow-up date 26/01/2016
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 317
Recruitment status Completed
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 Eligible patients were assigned the lowest available number on the computer-generated randomization list in envelop provided by the study statistician assigning them to Dihydroartemisinin-piperaquine (Salvat), or Artemether-lumefantrine (Novartis). A block size randomization technique was used with a varying block feature to minimize the investigator in knowing the treatment arm prior the treatment assignment. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dihydroartemisinin-piperaquine (Malacur) DHA-PQ was administrated according to body weight (10¿19.9 kg: one tablet; 20¿39.9 kg: two tablets; ¿ 40 kg: three tablets). DHA-PQ suspension was administrated to body weight (3.5 to 5 Kg: 5ml; 6 to 3 days The first formulation was a blister of tablets, each containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine (PQ). The second formulation was an oral suspension of 90 mg of DHA and 720 mg of PQ in 60 ml solution (for children). 159
Control Group Artemether-lumefantrine (AL) AL was administrated according to body weight (5¿14 kg: one tablet; 15¿24 kg: two tablets; 25¿34 kg: three tablets; ¿ 35 kg: four tablets). 3 days AL was a fixed-dose combination tablets, each containing 20 mg of artemether and 120 mg of lumefantrine. DHA-PQ and AL were administrated according to body weight 158 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria were: older than or equal to six months, with an axillary temperature of ¿ 37°Celcius or history of fever within 24 hours prior enrollment, being resident of Doneguebougou and Torodo since six months, able to take oral treatment, a parasitemia between 1000 and 100,000 asexual Plasmodium falciparum/¿l of blood, having QTc ¿ 450 msec, to sign an informed written consent and to have not used any ACTs components within 28 days before enrollment. Patients were excluded if they had symptoms or signs of severe malaria, were unable to take oral medication, had an allergy to one of the study drugs or were pregnant (detected with a urine beta-human chorionic gonadotropin test). 5 Year(s) 100 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 20/12/2012 Comité d'ethique de la Faculté de Medecine, de Pharmacie et d'odonto-stomatologie
Ethics Committee Address
Street address City Postal code Country
Point Bamako 1805 Mali
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adequate Clinical and Parasitological Response Day 28 Day 42
Secondary Outcome Anemia clearance Day 0 Day 28 Day 42
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Doneguebou Kati Bamako 1805 Mali
FUNDING SOURCES
Name of source Street address City Postal code Country
This study funded by Laboratorios SALVAT, S.A. Gall, 30-36, 08950 Barcelona 08950 Spain
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratorios SALVAT, S.A., Gall, 30-36, 08950 Barcelona 08950 Spain Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Malaria Research and Training Center Faculté de Pharmacie, Point-G, Bamako 1805 Mali
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Souleymane Dama dama@icermali.org 0022320228109 Faculté de Pharmacie, Point-G
City Postal code Country Position/Affiliation
Bamako 1805 Mali Post Doc
Role Name Email Phone Street address
Public Enquiries Issaka Sagara isagara@icermali.org 0022320228109 Faculté de Pharmacie, Point-G
City Postal code Country Position/Affiliation
Bamako 1805 Mali
Role Name Email Phone Street address
Scientific Enquiries Ogobara Doumbo okd@icermali.org 0022320228109 Faculté de Medecine, Point-G
City Postal code Country Position/Affiliation
Bamako 1805 Mali
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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