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.: PACTR202106708800075 Date of Approval: 23/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of population diversity of Plasmodium falciparum isolates from children with uncomplicated infection during the adoption of artemisinin-based combination therapy in Nigeria
Official scientific title Evaluation of population diversity of Plasmodium falciparum isolates from children with uncomplicated infection during the adoption of artemisinin-based combination therapy in Nigeria
Brief summary describing the background and objectives of the trial Antimalaria drug resistance, largely driven by drug pressure, evolves over time following the deployment of drug. While Artemisinin-based combination treatments (ACTs) remain the most efficacious first-line treatments for uncomplicated falciparum malaria globally, the emergence and spread of artemisinin-resistant Plasmodium falciparum in the Greater Mekong sub-region threatens its efficacy. Report of declining responsiveness, in vivo, to ACTs 10 years following deployment in southwest Nigeria has necessitated molecular evaluation of the population changes in circulating parasites in Nigeria. There are few focused studies revealing variations in the population structure of circulating P. falciparum strains in southwestern Nigeria. For this reason, this research work is conceptualized. The main objective is to describe, if any, temporal patterns of change in P. falciparum populations in southwest Nigeria since adoption of ACTs. Specific objectives are; (i) Evaluation of efficacy of Dihydroartemisinin-piperaquine in children with uncomplicated falciparum malaria, (ii) Description of population diversity of circulating parasite using microsatellite assay and (iii) Correlation of the diversity with pathophysiology of falciparum malaria and that of treatment outcome following ACTs.
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 21/06/2021
Actual trial start date
Anticipated date of last follow up 24/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
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 Randomised Simple randomization using a randomization table from a statistics book 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 Dihydroartemisinin-piperaquine will be given as a single daily dose as shown below for 3 days (days 0-2). The first day of presentation will be taken as Day 0. Dosage regimen for co-formulated Dihydroartemisinin-piperaquine Weight /Age Tablet Strength Dosage Regimen ≥ 4.5kg - < 10 kg 20mg/160mg 1.5 tablet once daily for three days 10kg - < 16 kg 40mg/320mg 1.5 tablet once daily for three days 16kg – 24kg 40mg/320mg 2 tablets once daily for three days 24kg- <34kg 40mg/320mg 2.5-3 tablets once daily for three days 34kg - <50kg 40mg/320mg 2.5-3 tablets once daily for three days Three (3) days Dihydroartemisinin–piperaquine (DPQ) is a fixed-dose artemisinin-based combination therapy of dihydroartemisinin (DHA) and piperaquine phosphate (PQP). It is a World Health Organization (WHO) recommended drug for the treatment of Plasmodium falciparum malaria globally. The co-formulated Dihydroartemisinin-piperaquine combination tablets exist in the ratio 1:8. It is taken by mouth 75
Control Group Artemether Lumefantrine Artemether Lumefantrine will be given daily as shown below for 3 days (days 0-2). The first day of presentation will be taken as Day 0. Dosage regimen for co-formulated Artemether Lumefantrine Weight Dosage Regimen 5kg - 14 kg 1 tablet twice daily for three days 15kg - 24 kg 2 tablets twice daily for three days 25kg – 34kg 3 tablets twice daily for three days >34kg 4 tablets twice daily for three days Each tablet contains 20mg of artemether and 120mg of lumefantrine Twice daily for three (3) days Artemether Lumefantrine is a combination of the two medications artemether and lumefantrine. It is used to treat malaria caused by Plasmodium falciparum that is not treatable with chloroquine. It is taken by mouth. 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age History of fever or fever (temp > 37.5oC) Mono P. falciparum infection with asexual parasitemia of ≥2000 mL-1 Written informed consent, including readiness to comply with follow-up visits by the child’s parent or guardian. Signs of severe malaria severe malnutrition History of allergy 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 6 Month(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 04/05/2021 Oyo state Ministry of Health Department of planning research and statistics division
Ethics Committee Address
Street address City Postal code Country
Oyo State Government Secretariat, Agodi, Ibadan, Oyo State, Nigeria Ibadan 230 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Responsiveness to drug treatment would be measured through Asexual parasite positivity, Parasite clearance time, Adequate clinical and parasitological response, terminal elimination halftime of asexual parasitaemia, area under curve of asexual parasitaemia, fever clearance time and anaemia recovery time. Daily
Secondary Outcome Semi-nested PCR amplification of 12 P. falciparum microsatellite loci will be used to determine the population diversity of isolates from children with uncomplicated infection. At the end of the clinical phase
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institute of Advanced Medical Research and Training College of Medicine, University of Ibadan, Ibadan, Oyo state, Nigeria. Ibadan 200 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Kazeem Akano Department of biological sciences, College of Natural sciences, Redeemers University, Ede, Osun state Ede Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kazeem Akano Department of biological sciences, Faculty of Natural sciences, Redeemers University, Ede, Osun state Ede Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Kazeem Akano Department of Biological sciences, Faculty of Natural sciences, Redeemers University, Ede, Osun state Ede 232102 Nigeria
Akintunde Sowunmi University of Ibadan Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Deborah Okeneye okeneye5127@run.edu.ng +2348133209981 Department of biological sciences, Faculty of Natural sciences, Redeemers university, Ede, Osun state
City Postal code Country Position/Affiliation
Ede 232102 Nigeria Postgraduate student
Role Name Email Phone Street address
Scientific Enquiries Kazeem Akano akanok@run.edu.ng +2348118464431 Department of Biological sciences, Faculty of Natural sciences, Redeemers university, Ede, Osun state
City Postal code Country Position/Affiliation
Ede 232102 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Kazeem Akano akanok@run.edu.ng +2348038644138 Department of Biological sciences, Faculty of Natural sciences, Redeemers university, Ede, Osun state
City Postal code Country Position/Affiliation
Ede Nigeria Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data shall include individual demographics, inclusion and exclusion criteria, treatment intervention, clinical outcomes of the treatment, and molecular profile of individual parasitemia. All these shall be kept in such a way that they do not have a direct link with the participants and data would be made available upon request. Clinical Study Report Within 12 months of completion of patient enrolment Data will be made available following the review of request. However, sensitive variables linked with individual participants shall remain confidential.
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