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Trial registered on ANZCTR
Registration number
ACTRN12612001128886
Ethics application status
Approved
Date submitted
17/10/2012
Date registered
23/10/2012
Date last updated
23/10/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Efficacy and safety of artesunate+sulfadoxine/ pyrimethamine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites of Somalia
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Scientific title
Therapeutic Efficacy Testing of artesunate+sulfadoxine/ pyrimethamine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites of Somalia
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Secondary ID [1]
281166
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
Nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malaria
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Condition category
Condition code
Infection
287668
287668
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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
Assessing the efficacy of artesunate+sulfadoxine/pyrimethamine (SP) combination therapy for the treatment of uncomplicated P. falciparum infections in one site (Jamame) in Somalia. Patients will be treated with artesunate (4mg/kg over 3 days) co-administered with sulfadoxine/pyrimethamine (single dose of 25mg sulfadoxine/1.25mg pyrimethamine per kg on day 0). Medicine will be administered orally.
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Intervention code [1]
285615
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Treatment: Drugs
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Comparator / control treatment
Assessing the efficacy and safety of artemether-lumefantrine combination therapy for the treatment of uncomplicated P. falciparum infections in two sites (Jannale and Jowhar) in Somalia. A fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet) will be administered according to the recommended weight as follows: One tablet to those weighing 5-14kg; two tablets for 15-24 kg; three tablets for 25-34 kg and four tablets for greater than 35 kg. The full course of treatment for all study patients consists of 6-doses given twice daily over 3 days. Medicine will be administered orally.
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Control group
Active
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Outcomes
Primary outcome [1]
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Percent of treatment failure (early treatment failure, late clinical failure, late parasitological failure).
Enrolled patients will be assessed for parasitological (using microscopy), clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.
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Assessment method [1]
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Timepoint [1]
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at day 28 following treatment
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Secondary outcome [1]
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Percent of adverse event will be documented. Parents or guardians of all enrolled patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded on the case report form.
Possible medicine related adverse effects include dizziness, itching, vomiting, abdominal pain, flatulence, headache, bodyache, diarrhoea, tinnitus and increased hair loss, macular rash, reduction in neutrophil counts and convulsions. However, it is likely that many of these effects are disease-related rather than medicine-induced.
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Assessment method [1]
299042
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Timepoint [1]
299042
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at day 28 following treatment
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Eligibility
Key inclusion criteria
1. age between 6 months and 60 years with the exception of 12-18 years old female minors and unmarried females above 18 years;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 500 - 200000/microlitre asexual forms;
4. presence of axillary temperature equal to or greater than 37.5 degrees C or history of fever during the past 24 hours;
5. ability to swallow oral medication;
6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
7. informed consent from the patient or from a parent or guardian in the case of children.
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Minimum age
6
Months
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Maximum age
60
Years
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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
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
2. mixed or mono-infection with another Plasmodium species detected by microscopy;
3. presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 110 mm);
4. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
5. regular medication, which may interfere with antimalarial pharmacokinetics;
6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and
7. a positive pregnancy test or breastfeeding;
8. Unable to or unwilling to take a pregnancy test or contraceptives.
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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)
Subjects between 6 months and 60 years with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on the respective sites with either artemether/lumefantrine or artesunate-sulfadoxine/pyrimethamine and monitored for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The treatments will be site specific.
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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
Parallel
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Other design features
Nil
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/08/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
264
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4532
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Somalia
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State/province [1]
4532
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Funding & Sponsors
Funding source category [1]
285940
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Other Collaborative groups
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Name [1]
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World Health Organization
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Address [1]
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Avenue Appia 20
1211 Geneva 27
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Country [1]
285940
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Switzerland
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Primary sponsor type
Government body
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Name
Ministry of Health and Human Services
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Address
Transitional Federal Government
Mogadishu
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Country
Somalia
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Secondary sponsor category [1]
284763
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None
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Name [1]
284763
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Address [1]
284763
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Country [1]
284763
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ministry of Health & Human Service, Somalia
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Ethics committee address [1]
287971
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Office of the Minister
Transistional Federal Government,
Mogadishu
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Ethics committee country [1]
287971
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Somalia
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Date submitted for ethics approval [1]
287971
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20/06/2012
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Approval date [1]
287971
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20/06/2012
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Ethics approval number [1]
287971
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MOH&HS/MO/223/2012
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Ethics committee name [2]
287972
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Ethical Review Committee, World Health Organization
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Ethics committee address [2]
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Avenue Appia 20
1211 Geneva 27
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Ethics committee country [2]
287972
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Switzerland
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Date submitted for ethics approval [2]
287972
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24/07/2012
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Approval date [2]
287972
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27/08/2012
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Ethics approval number [2]
287972
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RPC534
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Summary
Brief summary
Therapeutic efficacy testing of artemether/lumefantrine and artesunate+sulfadoxine/pyrimethamine combination therapies
for the treatment of uncomplicated P. falciparum infections in Somalia.
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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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Address
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Country
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Phone
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Fax
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Email
34665
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Contact person for public queries
Name
17912
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Mr Abdullahi Mohamed Hassan
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Address
17912
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Ministry of Health and Human Services,
Transistional Federal Government,
Mogadishu, Somalia
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Country
17912
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Somalia
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Phone
17912
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+252615500514
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Fax
17912
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Email
17912
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[email protected]
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Contact person for scientific queries
Name
8840
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Mr Abdullahi Mohamed Hassan
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Address
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Ministry of Health and Human Services,
Transistional Federal Government,
Mogadishu, Somalia
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Country
8840
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Somalia
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Phone
8840
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+252615500514
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Fax
8840
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Email
8840
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
Efficacy of artesunate + sulphadoxine/pyrimethamine and artemether + lumefantrine and dhfr and dhps mutations in Somalia: evidence for updating the malaria treatment policy.
2017
https://dx.doi.org/10.1111/tmi.12847
N.B. These documents automatically identified may not have been verified by the study sponsor.
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