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Trial registered on ANZCTR


Registration number
ACTRN12612001118897
Ethics application status
Approved
Date submitted
4/09/2012
Date registered
19/10/2012
Date last updated
19/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapeutic efficacy testing of artemether lumefantrine and artesunate+sulfadoxine/pyrimethamine combination therapies
for the treatment of uncomplicated P. falciparum infections in Mali.
Scientific title
Therapeutic efficacy testing of artemether lumefantrine and artesunate+sulfadoxine/pyrimethamine combination therapies
for the treatment of uncomplicated P. falciparum infections in Mali.
Secondary ID [1] 281142 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 287310 0
Condition category
Condition code
Infection 287648 287648 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessing the efficacy and safety of artemether-lumefantrine combination therapy for the treatment of uncomplicated P. falciparum infections in Mali. Drug is to be administered orally using the following regimen according to body mass: twice a day for three days - 20:120mg - less than 15kg - 1 tablet, 15 - 25 kg - 2 tablets, 25 - 35 kg - 3 tablets, more than 35kg - 4 tablets
Intervention code [1] 285600 0
Treatment: Drugs
Comparator / control treatment
Assessing the efficacy of artesunate+sulfadoxine/pyrimethamine (SP) combination therapy for the treatment of uncomplicated P. falciparum infections in Mali. This combination will be dosed at 4mg/kg/day of artesunate and 25mg/kg/day of SP, one tablet daily for three days.
Control group
Active

Outcomes
Primary outcome [1] 287898 0
Percentage 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] 287898 0
at day 28 following treatment
Secondary outcome [1] 299017 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] 299017 0
at day 28 following treatment

Eligibility
Key inclusion criteria
1. All patients above 6 months of age;
2. Malaria positive P. falciparum mono-infection;
3. Parasite density of 1,000-100,000 parasites;
4. Axillary temperature greater than or equal to 37.5 degrees celsius 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.
7. Informed consent from the patient or from a parent or guardian in the case of children.
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO in children (aged 6- 59 months);
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).
7. Female adolescents (12-18 years), pregnant or breast-feeding women;

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 over 6 months with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site 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)
N/A This surveillance study is 2 x one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria with either artemether/lumefantrine or artesunate-sulfadoxine/pyrimethamine
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
15/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
552
Accrual to date
Final
Recruitment outside Australia
Country [1] 4524 0
Mali
State/province [1] 4524 0

Funding & Sponsors
Funding source category [1] 285925 0
Other Collaborative groups
Name [1] 285925 0
World Health Organization
Country [1] 285925 0
Switzerland
Primary sponsor type
Government body
Name
Malaria Research and Training Center
Address
Ministere de l'Enseignement Superieur et de la Recherche Scientifique
Faculte de medecine de Pharmacie et d'Odonto Stomatologie
BP 1805
Bamako
Country
Mali
Secondary sponsor category [1] 284746 0
None
Name [1] 284746 0
Address [1] 284746 0
Country [1] 284746 0
Other collaborator category [1] 277052 0
University
Name [1] 277052 0
Service Universitaire de Parasitologie-Mycologie
Address [1] 277052 0
Faculte de Medecine Toulouse Rangueil
Centre Hospitalier Universitaire Rangueil
Toulouse 31059 Cedex
Country [1] 277052 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287952 0
Ethical Review Committee, World Health Organization
Ethics committee address [1] 287952 0
Ethics committee country [1] 287952 0
Switzerland
Date submitted for ethics approval [1] 287952 0
03/07/2012
Approval date [1] 287952 0
17/07/2012
Ethics approval number [1] 287952 0
RPC527

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34654 0
Address 34654 0
Country 34654 0
Phone 34654 0
Fax 34654 0
Email 34654 0
Contact person for public queries
Name 17901 0
Pr Ogobara K. Doumbo
Address 17901 0
Malaria Research and Training Center (MRTC)
Bamako BP 1805
Country 17901 0
Mali
Phone 17901 0
+223 2022 81 09
Fax 17901 0
Email 17901 0
okd@icermali.org
Contact person for scientific queries
Name 8829 0
Dr Antoine Dara, PharmD
Address 8829 0
Malaria Research and Training Center (MRTC)
Bamako BP 1805
Country 8829 0
Mali
Phone 8829 0
+223 2022 81 09
Fax 8829 0
Email 8829 0
tonydara@icermali.org

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
No additional documents have been identified.