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.: PACTR202309773069812 Date of Approval: 01/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of antimalaria drug for the treatment of malaria
Official scientific title Therapeutic efficacy and safety of Artemether-Lumefantrine combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria at Teda Health Center, Northwest Ethiopia
Brief summary describing the background and objectives of the trial Malaria control and elimination plan is dependent on efficacious drugs of Artemisinin based combination therapies. However, drug resistance was detected for these drugs in low-transmission settings and was predicted to emerge in high-transmission settings, including Ethiopia. This study aimed to assess the therapeutic efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria.
Type of trial Observational
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 10/09/2022
Actual trial start date 12/09/2022
Anticipated date of last follow up 10/01/2023
Actual Last follow-up date 08/02/2023
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants) 88
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised 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
Experimental Group treatment drug 20mg/ 120mg artemether lumefantrine twice daily three days Patients with uncomplicated P. falciparum malaria who fulfilled the study eligibility criteria were enrolled, treated and observed for 28 days. 88
Control Group no intervention no no no 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age 6 months–70 years • No history of malaria treatment within the last 28 days • Permanent resident within 5 km radius from the HC • Plasmodium falciparum infection confirmed by microscopy • Parasitaemia level of 1,000/µl-100,000/µl asexual forms • Presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24hs • Ability to swallow oral medication • Ability to comply to the study protocol • Presence of complication or danger signs of severe malaria • Presence of severe malnutrition (body mass index (BMI) <18.5 kg/m2 or z-score <3) • Presence of known diseases other than malaria (typhoid fever, typhus, hepatitis, HIV/AIDS, pneumonia and tuberculosis) • Regular medications that may interfere with AL pharmacokinetics (antiretroviral, ketoconazole and rifampicin) • History of hypersensitivity reactions to AL • Pregnancy or lactating women • Vomited twice during drug administration Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,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 31/08/2022 Ethics committee of School of biomedical and laboratory sciences University of Gondar
Ethics Committee Address
Street address City Postal code Country
6200 Gondar 6200 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome adequate clinical and parasitological response Day 28
Secondary Outcome Asexual parasitaemia and fever clearance Day 1, 2 and 3
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Teda health center Gondar Gondar Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Gondar Gondar Gondar 6200 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Gondar Gondar Gondar 6200 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Armauer Hansen Research Institute Addis Ababa Addis Ababa 1165 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dagmawi Woldesenbet dagmawi2929@gmail.com +251912751911 Gondar
City Postal code Country Position/Affiliation
Gondar 6200 Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries Alemayehu Nigussie alex.nigussie@gmail.com +251928701023 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa 1153 Ethiopia Researcher
Role Name Email Phone Street address
Scientific Enquiries Degfe Woldesenbet dagiwoldeyemami@gmail.com +251923515885 Gondar
City Postal code Country Position/Affiliation
Gondar 6200 Ethiopia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial, as well as the study protocol used, will be shared immediately after publication and for the next ten years with researchers who provide a methodologically sound proposal to achieve the goals in the approved proposal or individual participant metanalysis at the request of the corresponding author or last author. dagmawi2929@gmail.com or tyalewayker@yahoo.com Informed Consent Form,Study Protocol Immediately after publication and for the next ten years Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 06/07/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 06/07/2023 Result - 06/07/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.who.int/docs/default-source/documents/publications/gmp/methods-for-surveillance-of-antimalarial-drug-efficacy.pdf?sfvrsn=29076702_2
Changes to trial information