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.: PACTR201305000552290 Date of Approval: 15/05/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Monitoring the efficacy and safety of Dihydro-Artémisinine-Piperaquine, Artemether-lumefantrine and Artesunate-Amodiaquine for malaria treatment
Official scientific title MONITORING THE EFFICACY AND THE SAFETY OF THREE ARTEMISININ COMBINATIONS THERAPIES (ACT) IN SENEGAL: RESULTS FROM TWO YEARS SURVEILLANCE
Brief summary describing the background and objectives of the trial Background: After the scaling up of ACT in Senegal and the and the recent appearance of a susceptibility decrease of Plasmodium falciparum to artemisinin based combination therapy in Asia, , it becomes necessary to monitor the use of ACT in Africa west. Objectives: assessment the efficacy and safety of three artemisinin combinations therapies for the treatment of uncomplicated Plasmodium falciparum malaria in Senegal
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 13/10/2011
Actual trial start date 13/10/2011
Anticipated date of last follow up 05/02/2013
Actual Last follow-up date 05/02/2013
Anticipated target sample size (number of participants) 450
Actual target sample size (number of participants) 534
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 simple randomisation using stata software Numbered containers Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using stata software Numbered containers Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using stata software Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group AL AL given according to weight twice a day 3 days Current first line treatment in Senegal 178 Active-Treatment of Control Group
Experimental Group Artesunate Amodiaquine (ASAQ) Dosing according to weight once daily 3 days Alternative treatment to AL 180
Experimental Group Dehydroartemisinine Piperaquine (DHAPQ) Dosing according to weight once daily 3 days Alternative treatment to AL 176
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects aged over 6 months with the uncomplicated P. falciparum malaria, Parasite density between 1000 and 100000 trophozoites/¿l, Presence of an axillary temperature higher than 37.5° or history of fever during the previous 24 hours, Ability to take oral medication and given her inform consent were included in the study Patients presenting mono-infestation by another species or mixted infestation, severe vomiting, severe malnutrition, severe signs of malaria (such as severe anemia, convulsion, respiratory distress), women with positive pregnancy test and patients who had a history of allergy to study drugs or not given her inform consent were excluded in the study 1 Year(s) 65 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 05/07/2011 Comité National d'Ethique et de Recherche en Santé
Ethics Committee Address
Street address City Postal code Country
Avenue Aimé Césaire Dakar Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome adequate clinical and parasitological response (ACPR) after corrected PCR at day 28 Day 28
Secondary Outcome ACPR at days 35 and 42 Days 35 and 42 of follow up
Secondary Outcome Parasite and fever clearence time daily
Secondary Outcome Incidence of drug related adverse events daily
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Keur Soce Health post Kaolack Senegal
Pikine (Deggo Health Post) Pikine Dakar Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
National Malaria control Program Avenue Aimé césaire Dakar Senegal
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University Cheikh Anta DIOP of Dakar Avenue Cheikh Anta Diop Dakar 5005 Dakar Fann Senegal University
COLLABORATORS
Name Street address City Postal code Country
Centre de Santé de Pikine Pikine Dakar Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oumar Gaye ogaye@refer.sn 221 33 825 19 98 Avenue Cheikh Anta Diop UCAd
City Postal code Country Position/Affiliation
Dakar 5005 Senegal University of Dakar
Role Name Email Phone Street address
Public Enquiries Magatte NDiaye magou22000@yahoo.fr 00 221 77 609 11 07 Avenue Aimé Césaire
City Postal code Country Position/Affiliation
Dakar Senegal Focal point of antimalarial drugs resistance in the department of Parasitology
Role Name Email Phone Street address
Scientific Enquiries Babacar Faye bfaye67@yahoo.fr 221 33 825 19 98 Avenue Cheikh Anta Diop UCAd
City Postal code Country Position/Affiliation
Dakar 5005 Senegal University of Dakar
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