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Trial registered on ANZCTR
Registration number
ACTRN12624000909527
Ethics application status
Approved
Date submitted
17/05/2024
Date registered
25/07/2024
Date last updated
25/07/2024
Date data sharing statement initially provided
25/07/2024
Date results provided
25/07/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Djibouti-ville, Djibout
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Scientific title
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Djibouti-ville, Djibout
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Secondary ID [1]
312169
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
ACTRN12624000526572 is a study conducted in Yemen while 387824 is study just completed in Djibouti.
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Health condition
Health condition(s) or problem(s) studied:
Malaria
333819
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Condition category
Condition code
Infection
330489
330489
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This was a single arm prospective study to assess the efficacy and safety of artemether-lumefantrine. Tablets containing 20 mg artemether and 120 mg lumefantrine in each tablet was given twice daily for three consecutive 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 study nurse. Patients were followed up for 28 days. For children, tablets were crushed and added to water in spoon and given to them.
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Intervention code [1]
328612
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Proportion of treatment failures (early treatment failure + late clinical failure+late parasitological failure). This is a composite primary outcome.
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Assessment method [1]
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Assessments were done clinically and parastologically using malaria microscopy. PCR analysis on blood samples on day 0 and day of parasite recurrence was done to differentiate recrudescence from new infection.
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Timepoint [1]
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Days 0 (prior to treatment), 1, 2 (during treatment),3, 7, 14, 21, 28 (post-treatment) for artemether-lumefantrine
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Secondary outcome [1]
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Percent of adverse event following treatment of artemether-lumefantrine or dihydroartesmisinin-piperaquine will be investigated.
The known adverse events of atemether-lumefantrine are abdominal pain, asthenia, cough, diarrhoea, dizziness, fever, headache, joint and muscle pain, loss of appetite, rush, nausea, vomiting. Those for dihydroartemisinin include asthenia, cough, diarrhoea, fever, loss of appetite, nausea, vomiting.
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Assessment method [1]
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Patients or care takers of children were asked on each visit about previous symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients were assessed and treated appropriately. All adverse events will be recorded on the case report form.
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Timepoint [1]
435196
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Days 0 (prior to treatment), 1, 2 (during treatment),3, 7, 14, 21, 28 (post-treatment) for artemether-lumefantrine
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Eligibility
Key inclusion criteria
• age between 6 months 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
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Minimum age
6
Months
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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;
• 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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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
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
28/02/2024
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Date of last participant enrolment
Anticipated
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Actual
16/03/2024
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Date of last data collection
Anticipated
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Actual
13/04/2024
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Sample size
Target
88
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Accrual to date
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Final
95
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Recruitment outside Australia
Country [1]
26312
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Djibouti
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State/province [1]
26312
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Djibouti
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Ministry of Health of Djibouti
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Address [1]
316535
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Country [1]
316535
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Djibouti
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Primary sponsor type
Government body
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Name
Ministry of Health of Djibouti
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Address
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Country
Djibouti
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Secondary sponsor category [1]
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None
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Name [1]
318715
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Address [1]
318715
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Country [1]
318715
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315328
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Eastern Mediterranean Regional Ethics Research Committee (EMR-RERC
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Ethics committee address [1]
315328
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Monazamet El Seha El Alamia Street, Extension of Abdel Razak El Sanhouri Street P.O. Box 7608, Nasr City Cairo 11371, Egypt
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Ethics committee country [1]
315328
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Djibouti
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Date submitted for ethics approval [1]
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26/09/2023
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Approval date [1]
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06/10/2023
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Ethics approval number [1]
315328
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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 Djibouti was assessed.. 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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Samatar Kayad Guelleh
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Address
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National Malaria Control Programme, Avenue George Clemenceau, P.O. Box 1974, Djibouti city, Djibouti region
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Country
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Djibouti
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Phone
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+25377705311
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Samatar Kayad Guelleh
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Address
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National Malaria Control Programme, Avenue George Clemenceau, P.O. Box 1974, Djibouti city, Djibouti region
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Country
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Djibouti
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Phone
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+25377705311
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Fax
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Email
134355
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[email protected]
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Contact person for scientific queries
Name
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Marian Warsame
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Address
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Department of Public Health and Community Medicine, Medicinaregatan 18A, 41390 Göteborg
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Country
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Sweden
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Phone
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+46760525254
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Fax
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Email
134356
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Documents were uploaded by study researchers but have since been removed.
Documents added automatically
No additional documents have been identified.
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