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.: PACTR202108584742856 Date of Approval: 23/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Molecular Surveillance of Artemisinin Resistance Markers and Impact on Treatment Outcome in Patients with Acute Uncomplicated Plasmodium falciparum Malaria in South-West Nigeria
Official scientific title Molecular Surveillance of Artemisinin Resistance Markers and Impact on Treatment Outcome in Patients with Acute Uncomplicated Plasmodium falciparum Malaria in South-West Nigeria
Brief summary describing the background and objectives of the trial Malaria remains a disease of global public health concern. Artemisinin-based Combination Therapies (ACTs) are the cornerstone for malaria treatment in endemic countries, and their use and deployment have been instrumental in significant reduction in malaria-related morbidity and mortality. Unfortunately, emergence and spread of resistance to artemisinin and its derivatives by P. falciparum first reported in south east Asia is threatening malaria control and elimination efforts. The potential of artemisinin resistant parasites to widely spread to Africa from south east Asia remains high following similar trends with chloroquine resistant parasite distribution. This therefore necessitates an extensive monitoring of possible spread of resistance to the artemisinins in sub-Saharan Africa. Specific objectives 1. To evaluate the current efficacy of artemether-lumefantrine in children with acute uncomplicated P. falciparum infection. 2. To assess the prevalence of selected artemisinin resistance markers (Pfkelch13, Pfcoronin, PfCarl and Pfmdr2 gene mutations) in south-west Nigeria. 3. To evaluate the correlation between treatment outcome (including delayed clearance of parasitemia) and the artemisinin resistance markers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ARM
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 29/06/2021
Actual trial start date 29/06/2021
Anticipated date of last follow up 30/11/2031
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status 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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dihydroartemisinin Piperaquine tablet 4.5 -<10kg: 30/240mg of DHP (3/4 tablet) 10-<16kg: 60/480mg of DHP (1.5 tablets) 16-<24kg: 80/640mg of DHP (2 tablets) 24-<34kg: 100/800mg of DHP (2.5 tablets) 34-<50kg: 120/960mg of DHP (3 tablets) > or equal to 50kg: 120/1020mg of DHP (3.5 tablets 3 days Dihydroartemisinin Piperaquine tablet (40/320mg) 100
Experimental Group Artemether Lumefantrine 5–14 kg will receive one tablet, those weighing > 14–24 kg will receive two tablets, those weighing > 25 - 34 kg will receive 3 tablets and those weighing > 34 kg will receive four tablets, at presentation (0 hour), 8 hours later, and at 24, 36, 48, and 60 hours after administration of the first dose. 3 days Artemether Lumefantrine (20/120mg) 100
Control Group Negative control nil intervention Nil Nil Plasmodium falciparum negative participants will receive nothing 10 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(i) Age 1 to 15 years with symptoms compatible with acute uncomplicated Plasmodium falciparum infection (ii) P. falciparum parasitemia ≥ 2,000 asexual forms of parasite per μL of blood, (iii) Body (axillary) temperature ≥ 37.5°C, or history of fever within one to two days preceding presentation, (iv) Absence of other concomitant illnesses, (v) Absence of any history of antimalarial drug use within 2 weeks prior to presentation, (vi) Written informed consent from parents or guardians of participants. (i) severe malaria, (ii) severe malnutrition, (iii) serious underlying diseases (renal, cardiac, or hepatic), (iv) known allergic reaction to study drug. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 15 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 18/06/2021 Oyo state ethics committee
Ethics Committee Address
Street address City Postal code Country
Ministry of health, Oyo state Secretariat, agodi Ibadan Ibadan 200223 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Treatment success or failure Day 42 of treatment
Secondary Outcome Response of patient to treatment will be classified as follows: (i) adequate clinical and parasitological response (ACPR), (ii) late parasitological failure (LPF), (iii) late clinical failure (LCF) and (iv) early treatment failure (ETF), (v) Slow clearance will be defined as failure to clear parasitemia by day 3 (WHO, 2018). Day 42
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institute of Medical Research and Training. College of Medicine, University of Ibadan Ibadan 200223 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Department of Pharmacology and Toxicology, Faculty of Pharmacy, University of Ibadan Ibadan 200284 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amusan Abiodun University of Ibadan Ibadan 200284 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abiodun Amusan amusanabiodun86@gmail.com +23407031189247 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200284 Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Olugbenga Akinola Gbenga_akinola@ymail.com +23408038160637 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200284 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Abiodun Amusan amusanabiodun86@gmail.com +2347031189247 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 200284 Nigeria Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The participants data will be in the custody of the principal investigator and deidentified. The result of the findings will be published in a reputable journal after the completion of the research. Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months Scientific journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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