Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000396729
Ethics application status
Approved
Date submitted
5/04/2013
Date registered
11/04/2013
Date last updated
11/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Kobeni (province of Hodh El Gharbi) and Timbedra (province of Echargui), Mauritania
Scientific title
Efficacy and safety of artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Kobeni (province of Hodh El Gharbi) and Timbedra (province of Echargui), Mauritania
Secondary ID [1] 282275 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated P falciparum malaria 288786 0
Condition category
Condition code
Infection 289147 289147 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cure rate in terms of adequate clinical and parasitological response following a 3 day course of artesunate/amodiaquine co-formuated in three different fixed tablet strengths containing artesunate (mg)/amodiaquine (mg) as follows: 25/67.5; 50/135, or 100/270. The tablet strength and the number of tablets to be orally administered once a day will be based on body weight according to national treatment guideines and the dosing schedule appended to the protocol. Each daily dose will be administered under study staff supervision and patients will be followed-up for 28 days.
Intervention code [1] 286882 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289255 0
Cure rate at day 28 after adjustment by polymerase chain reaction (PCR) to differentiate between recrudescence and new infection.
Timepoint [1] 289255 0
day 28
Secondary outcome [1] 302114 0
Incidence of adverse events as reported by patients or observed by investigators. Clinical laboratory studies (hematology or biochemistry) may be required to confirm a diagnosis or to follow-up an adverse event.
Timepoint [1] 302114 0
day 28

Eligibility
Key inclusion criteria
6 months and older
microscopically confirmed mono-infection with P falciparum
parasitaemia between 250 and 100,000 asexual parasites/microliter
axillary temperature greater or equal to 37.5 degrees Celsius or history of fever within the past 24 hours
able to swallow medication
able to comply with the protocol and schedule of assessments
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 5 years or signs of severe falciparum malaria according to the definitions of WHO
mixed infection with another plasmodium species detected my microscopy
presence of severe malnutrition
presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehaydration) or other known underlying chronic or severe diseases
regualr medication tha tmight interfere with antimalrial pharmacokinetics
history of hypersensitivity reactions or contraindications to any medicines being tested or used as alternative treatments,
positive pregnancy test or breast feeding in married women
adolecents between 12 and 18 or unmarried single women in whom pregnancy test may not be performed.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2013
Actual
Date of last participant enrolment
Anticipated
31/10/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 4982 0
Mauritania
State/province [1] 4982 0
Kobeni
Country [2] 4983 0
Mauritania
State/province [2] 4983 0
El Hodh Echargui

Funding & Sponsors
Funding source category [1] 287025 0
Government body
Name [1] 287025 0
Ministry of Health Mauritania
Country [1] 287025 0
Mauritania
Funding source category [2] 287026 0
Other
Name [2] 287026 0
World Health Organisation
Country [2] 287026 0
Switzerland
Primary sponsor type
Government body
Name
Ministry of Health Mauritania
Address
Ministry of Health
BP 169
Nouakchott
Mauritania
Country
Mauritania
Secondary sponsor category [1] 285807 0
None
Name [1] 285807 0
Address [1] 285807 0
Country [1] 285807 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289064 0
World Health Organisation, Ethical Review Committee (WHO ERC)
Ethics committee address [1] 289064 0
20 avenue Appia
CH 1211 Geneva 27
Switzerland
Ethics committee country [1] 289064 0
Switzerland
Date submitted for ethics approval [1] 289064 0
Approval date [1] 289064 0
28/03/2013
Ethics approval number [1] 289064 0
RPC563

Summary
Brief summary
This is a therapeutic efficacy study of artesunate-amodiaquine, the current first-line drug for the treatment of uncomplicated malaria in Mauritania. Eligible subjects will be enrolled and treated for 3 days according to national treatment guidelines and will be followed up for 28 days. The results will be used to formulate recommendations and to enable the Minstry of Health to make informed decisions about whether the current national antimalaria treatment guidelines should be updated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39054 0
Dr Mamadou Dit Dialaw
Address 39054 0
National Malaria Control Program
Ministry of Health
Box 169
Nouakchott
Mauritania
Country 39054 0
Mauritania
Phone 39054 0
+222 22 11 70 31
Fax 39054 0
Email 39054 0
mamadoutditdialawba@yahoo.fr
Contact person for public queries
Name 39055 0
Dr Mamadou Dit Dialaw
Address 39055 0
National Malaria Control Program
Ministry of Health
Box 169
Nouakchott
Mauritania
Country 39055 0
Mauritania
Phone 39055 0
+222 22 11 70 31
Fax 39055 0
Email 39055 0
mamadoutditdialawba@yahoo.fr
Contact person for scientific queries
Name 39056 0
Dr Mamadou Dit Dialaw
Address 39056 0
National Malaria Control Program
Ministry of Health
Box 169
Nouakchott
Mauritania
Country 39056 0
Mauritania
Phone 39056 0
+222 22 11 70 31
Fax 39056 0
Email 39056 0
mamadoutditdialawba@yahoo.fr

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
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