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.: PACTR202003802011316 Date of Approval: 16/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy study of antimalarial drugs in Senegal
Official scientific title Efficacy and safety of artemisinin‑based combination therapy and the implications of Pfkelch13 and Pfcoronin molecular markers in treatment failure in Senegal
Brief summary describing the background and objectives of the trial In 2006, Senegal adopted artemisinin-based combination therapy (ACT), as first-line treatment in the management of uncomplicated malaria. This study aimed to update the status of antimalarial efficacy ten years after their first introduction. Simultaneously, the sequences of Pfk13 and Pfcoronin on samples that were subject to treatment failure were also analyzed.
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 01/09/2018
Actual trial start date 09/09/2018
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date 06/02/2019
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 496
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 randomization using a randomization table created by a computer software program 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
Control Group ASAQ 28 days Enrolled patients were randomly allocated into the three drug arms: oral administration of Artesunate-Amodiaquine (ASAQ) using the WHO recommended therapeutic dose regimens 11. Patients were observed for 30 min after the drug administration for adverse events or vomiting the study drugs. Any patient who vomited was re-treated with the same dose of medicine and observed for an additional 30 min. If vomiting occurred again, the patient was withdrawn and treated with IV quinine and if necessary, the patient was referred to the nearest hospital. Paracetamol was offered to all feverish patients. 199 Active-Treatment of Control Group
Experimental Group AL 28 days Enrolled patients were randomly allocated into the three drug arms: oral administration of Artemether-Lumefantrine (AL) using the WHO recommended therapeutic dose regimens 11. Patients were observed for 30 min after the drug administration for adverse events or vomiting the study drugs. Any patient who vomited was re-treated with the same dose of medicine and observed for an additional 30 min. If vomiting occurred again, the patient was withdrawn and treated with IV quinine and if necessary, the patient was referred to the nearest hospital. Paracetamol was offered to all feverish patients. 200
Experimental Group DP 42 days Enrolled patients were randomly allocated into the three drug arms: oral administration of Dihydroarteminin-Piperaquine (DP) using the WHO recommended therapeutic dose regimens 11. Patients were observed for 30 min after the drug administration for adverse events or vomiting the study drugs. Any patient who vomited was re-treated with the same dose of medicine and observed for an additional 30 min. If vomiting occurred again, the patient was withdrawn and treated with IV quinine and if necessary, the patient was referred to the nearest hospital. Paracetamol was offered to all feverish patients. 97
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 6 months or above, had an axillary temperature ≥ 37.5 °C at presentation or history of fever during the last 24 hours, a positive P. falciparum mono-infection parasitemia of 1,000 to 100,000 asexual forms/ul, ability to swallow oral medication, ability and willingness to comply with the study protocol and visit schedule for the duration of the study, written informed consent from the patient or from the parent or guardian for enrolled children presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO , mixed or mono-infection with another Plasmodium species detected by microscopy, positive pregnancy test, severe malnutrition, febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases, regular medication, which may interfere with anti-malarial treatment, history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 6 Month(s) 70 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 14/07/2017 Ethic Committee of the Senegalese Ministry of Health and Social Affairs
Ethics Committee Address
Street address City Postal code Country
Rue Aime Cesaire Dakar 10500 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis Days 0, 1, 2, 3, 7, 14, 21, 28
Secondary Outcome The frequency and nature of adverse events Days 0, 1, 2, 3, 7, 14, 21, 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tomboronkoto Tomboronkoto Kedougou Senegal
Keur Serigne Mbaye Sarr Keur Serigne Mbaye Sarr Diourbel Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
National Malaria Control Program NMCP Rue Aime Cesaire Dakar Senegal
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cheikh Anta Diop University 30, Avenue Pasteur Dakar 16477 Senegal University
COLLABORATORS
Name Street address City Postal code Country
USAID Route des Almadies Hotel Meridien, NGOR Dakar Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Daouda Ndiaye daouad.ndiaye@ucad.edu.sn +221771213333 30, Avenue Pasteur
City Postal code Country Position/Affiliation
Dakar Senegal Head of department
Role Name Email Phone Street address
Scientific Enquiries Mamadou Alpha Diallo mamadoualpha.diallo@ucad.edu.sn +221772036108 30, Avenue Pasteur
City Postal code Country Position/Affiliation
Dakar Senegal Research scientist
Role Name Email Phone Street address
Public Enquiries Daba Zoumarou rwallisz@yahoo.fr +221775623151 30, Avenue Pasteur
City Postal code Country Position/Affiliation
Dakar Senegal Project manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Analytic Code,Clinical Study Report,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes A total of 496 patients were enrolled. In Diourbel, PCR non-corrected/corrected adequate clinical and parasitological responses (ACPR) was 100.0% in both AL and ASAQ arms. In Kedougou, PCR corrected ACPR were 98.8%, 100% and 97.6% in AL, ASAQ and DP arms respectively. No Pfk13 or Pfcoronin mutation associated to artemisinin resistance was found. This study showed that AL, ASAQ and DP remain efficacious and well tolerated in the treatment of uncomplicated falciparum malaria in Senegal. 10/03/2020 03/02/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.who.int/malaria/areas/drug_resistance/efficacy-monitoring-tools/en/
Changes to trial information