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Trial registered on ANZCTR


Registration number
ACTRN12624000526572
Ethics application status
Approved
Date submitted
21/02/2024
Date registered
27/04/2024
Date last updated
27/04/2024
Date data sharing statement initially provided
27/04/2024
Date results information initially provided
27/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Al Tor Bin Qais in Hajah, Yemen.
Scientific title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Al Tor Bin Qais in Hajah, Yemen.
Secondary ID [1] 311578 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 332953 0
Condition category
Condition code
Infection 329668 329668 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a single arm prospective study to evaluate the efficacy and safety of artemether-lumefantrine. Artemether-lumefantrine tablets (containing 20 mg artemether+ 120 mg lumefantrine in each tablet) was given two times daily for three days according to the recommended weight bands: 1 tablet to those weighing 5 to 14 kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for equal or greater than 35 kg. The total target dose ranges were 5-24 mg/kg body weight (bw)of artemether and 29-144 mg/kg bw of lumefantrine. All treatments was given orally under direct supervision by the health worker and patients were followed up for 28 days.Tablets were crushed and added to water in spoon and given to the child.
Intervention code [1] 328029 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337452 0
Proportion of treatment failures (early treatment failure + late clinical failure+late parasitological failure). This is a composite primary outcome.
Timepoint [1] 337452 0
Days 0 (prior to treatment), 1, 2 (during treatment),3, 7, 14, 21, 28 (post-treatment) for artemether-lumefantrine
Secondary outcome [1] 433883 0
Nil
Timepoint [1] 433883 0
NA

Eligibility
Key inclusion criteria
• age between 6 months and above, excluding female minors 12-17 years old and unmarried females aged 18 years and above;
• mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
• parasitaemia of 500-200000 per micrometer asexual forms;
• presence of axillary temperature greater or equal 37.5 degrees centigrade or history of fever during the past 24 h;
• ability to swallow oral medication;
• ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
• informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years;
• informed assent from any minor participant aged from 12 to age of majority years; and
• consent for pregnancy testing from married female aged 18n years and above.
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO;
• female aged from 12 years and below 18 years;
• weight under 5 kg;
• haemoglobin below 8 g per deciliter;
• mixed or mono-infection with another Plasmodium species detected by microscopy;
• presence of severe malnutrition defined as a child aged between 6-60 months who has a mid-upper arm circumference below 115 mm);
• presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
• regular medication, which may interfere with antimalarial pharmacokinetics;
• history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
• a positive pregnancy test or breastfeeding; and
• unable to or unwilling to take pregnancy test or to use contraception for married aged 18 years and above.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data was double entered by two independent data clerks using WHO database Excel programme, Data was analysed by both Kaplan-Meier and per-protocol methods. Patients were censored or excluded from the analysis if they were withdrawn or lost to follow-up or PCR results were unclassifiable or if the results of PCR indicate that the failure is due to reinfection with P. falciparum or P. vivax.

The final analysis will include:
• a description of all patients screened and the distribution of reasons for non-inclusion in the study;
• a description of all the patients included in the study;
• the proportion of adverse events and serious adverse events in all the patients included in the study;
• Prevalence of mutations in k13 gene associated with artemisinin partial resistance.;
• the proportion of patients lost to follow-up or withdrawn, with 95% confidence intervals and a list of reasons for withdrawal;
• the cumulative incidence of success and failure rates at day 28, PCR-uncorrected and PCR-corrected; and
• the proportion of early treatment failure, late clinical failure, late parasitological failure and adequate clinical and parasitological response at day 28, with 95% confidence intervals, PCR-uncorrected and PCR-corrected

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/03/2023
Date of last participant enrolment
Anticipated
Actual
13/05/2023
Date of last data collection
Anticipated
Actual
10/06/2023
Sample size
Target
88
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 26156 0
Yemen
State/province [1] 26156 0
Hajah

Funding & Sponsors
Funding source category [1] 315879 0
Government body
Name [1] 315879 0
The Ministry of Public Health and Population
Country [1] 315879 0
Yemen
Primary sponsor type
Government body
Name
The Ministry of Public Health and Population
Address
Country
Yemen
Secondary sponsor category [1] 318020 0
None
Name [1] 318020 0
Address [1] 318020 0
Country [1] 318020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314726 0
Eastern Mediterranean Regional Ethics Research Committee (EMR-RERC)
Ethics committee address [1] 314726 0
Monazamet El Seha El Alamia Street, Extension of Abdel Razak El Sanhouri Street P.O. Box 7608, Nasr City Cairo 11371, Egypt
Ethics committee country [1] 314726 0
Yemen
Date submitted for ethics approval [1] 314726 0
08/03/2022
Approval date [1] 314726 0
28/03/2022
Ethics approval number [1] 314726 0

Summary
Brief summary
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria infections in patients 6 months and above in Yemen was evaluated. The treatment was given under direct supervision and clinical and parasitological parameters were monitored for 28 days to establish proportion of patients with PCR corrected treatment failure, frequency of adverse events and mutations in K13 gene on day 0 samples.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132534 0
Dr Mustafa Abdulraouf Othman Al- Selwi
Address 132534 0
National Malaria Control Programme, Aljarda area, PO Box: 16544, Sana'a, Yemen
Country 132534 0
Yemen
Phone 132534 0
+967773395209
Fax 132534 0
Email 132534 0
[email protected]
Contact person for public queries
Name 132535 0
Mustafa Abdulraouf Othman Al- Selwi
Address 132535 0
National Malaria Control Programme, Aljarda area, PO Box: 16544, Sana'a, Yemen
Country 132535 0
Yemen
Phone 132535 0
+967773395209
Fax 132535 0
Email 132535 0
[email protected]
Contact person for scientific queries
Name 132536 0
Marian Warsame
Address 132536 0
Department of Public Health and Community Medicine, Medicinaregatan 18A, 41390 Göteborg
Country 132536 0
Sweden
Phone 132536 0
+46760525254
Fax 132536 0
Email 132536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.