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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
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
Secondary ID [1] 281166 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 287332 0
Condition category
Condition code
Infection 287668 287668 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285615 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 287911 0
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.
Timepoint [1] 287911 0
at day 28 following treatment
Secondary outcome [1] 299042 0
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.
Timepoint [1] 299042 0
at day 28 following treatment

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.
Minimum age
6 Months
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The treatments will be site specific.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4532 0
Somalia
State/province [1] 4532 0

Funding & Sponsors
Funding source category [1] 285940 0
Other Collaborative groups
Name [1] 285940 0
World Health Organization
Address [1] 285940 0
Avenue Appia 20
1211 Geneva 27
Country [1] 285940 0
Switzerland
Primary sponsor type
Government body
Name
Ministry of Health and Human Services
Address
Transitional Federal Government
Mogadishu
Country
Somalia
Secondary sponsor category [1] 284763 0
None
Name [1] 284763 0
Address [1] 284763 0
Country [1] 284763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287971 0
Ministry of Health & Human Service, Somalia
Ethics committee address [1] 287971 0
Office of the Minister
Transistional Federal Government,
Mogadishu
Ethics committee country [1] 287971 0
Somalia
Date submitted for ethics approval [1] 287971 0
20/06/2012
Approval date [1] 287971 0
20/06/2012
Ethics approval number [1] 287971 0
MOH&HS/MO/223/2012
Ethics committee name [2] 287972 0
Ethical Review Committee, World Health Organization
Ethics committee address [2] 287972 0
Avenue Appia 20
1211 Geneva 27
Ethics committee country [2] 287972 0
Switzerland
Date submitted for ethics approval [2] 287972 0
24/07/2012
Approval date [2] 287972 0
27/08/2012
Ethics approval number [2] 287972 0
RPC534

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34665 0
Address 34665 0
Country 34665 0
Phone 34665 0
Fax 34665 0
Email 34665 0
Contact person for public queries
Name 17912 0
Mr Abdullahi Mohamed Hassan
Address 17912 0
Ministry of Health and Human Services,
Transistional Federal Government,
Mogadishu, Somalia
Country 17912 0
Somalia
Phone 17912 0
+252615500514
Fax 17912 0
Email 17912 0
amhassan_labfocal@yahoo.com
Contact person for scientific queries
Name 8840 0
Mr Abdullahi Mohamed Hassan
Address 8840 0
Ministry of Health and Human Services,
Transistional Federal Government,
Mogadishu, Somalia
Country 8840 0
Somalia
Phone 8840 0
+252615500514
Fax 8840 0
Email 8840 0
amhassan_labfocal@yahoo.com

No information has been provided regarding IPD availability
Summary results
No Results