Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000411741
Ethics application status
Approved
Date submitted
6/04/2013
Date registered
15/04/2013
Date last updated
15/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of chloroquine for the treatment of Plasmodium vivax malaria in Teyarett District in Nouakchott and in the city of d'Atar (Adra Province) in Mauritania.
Scientific title
Efficacy and safety of chloroquine for the treatment of Plasmodium vivax malaria in Teyarett District in Nouakchott and in the city of d'Atar (Adra Province) in Mauritania.
Secondary ID [1] 282276 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasmodium vivax malaria 288789 0
Condition category
Condition code
Infection 289149 289149 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
Efficacy and safety of a total oral dose of 25 mg base per kg body weight of chloroquine over three consecutive days: 10 mg base on day 1 and day 2, and 5 mg base per kg on day 3. Each daily dose administration will be administered orally under supervision, and patients will be followed up for 28 days for clinical and parasitological assessments.
Intervention code [1] 286885 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289257 0
Cure rate in terms of adequate clinical and parasitological response at day 28 as determined by clinical examination and blood microscopy
Timepoint [1] 289257 0
day 28
Secondary outcome [1] 302117 0
incidence of adverse events as reported by patients or observed by investigators. Clinical laboratory studies may be reqired to confirm a diagnosis or to follow-up an adverse event.
Timepoint [1] 302117 0
day 28

Eligibility
Key inclusion criteria
age 6 months and older
mono-infection with P vivax detected by microscopy
asexual parasite count greater than 250 per microliter
axillary temperature greater than 37.5 degrees Celsius or history of fever during the 48 hours before recruitment
able to swallow oral medication
able and willing to comply with the protocol and schedule of assessments
informed consent


Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
clinical condition due to vivax malaria (coma, respiratory distress syndrome or severe anaemia) requiring hospitalisation
severe malnutrition according to WHO child growth standards
febrile condition 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 disease
history of hypersensitivity reactions to any medicine tested

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
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 4984 0
Mauritania
State/province [1] 4984 0
Teyarett/Nouakchott
Country [2] 4985 0
Mauritania
State/province [2] 4985 0
Atar/ Adrar province (2)

Funding & Sponsors
Funding source category [1] 287028 0
Government body
Name [1] 287028 0
Ministry of Health of Mauritania
Country [1] 287028 0
Mauritania
Funding source category [2] 287029 0
Other
Name [2] 287029 0
World Health Organisation
Country [2] 287029 0
Switzerland
Primary sponsor type
Government body
Name
Ministry of Health of Mauritania
Address
P.O. Box 169
Nouakchott
Mauritania
Country
Mauritania
Secondary sponsor category [1] 285809 0
None
Name [1] 285809 0
Address [1] 285809 0
Country [1] 285809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289065 0
World Health Organisation Ethics Review Committee (WHO ERC)
Ethics committee address [1] 289065 0
20 Avenue Appia
Ch 1211 Geneva 27
Switzerland
Ethics committee country [1] 289065 0
Switzerland
Date submitted for ethics approval [1] 289065 0
Approval date [1] 289065 0
28/03/2013
Ethics approval number [1] 289065 0
RPC 566

Summary
Brief summary
This is a therapeutic efficacy study of chloroquine, the current first line drug for the treatment of P vivax malaria in Mauritania. The results will be used to formulate recommendations and to enable the Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39066 0
Dr Mamadou Dit Dialaw
Address 39066 0
P.O. Box 169
Nouakchott
Mauritania
Country 39066 0
Mauritania
Phone 39066 0
+ 222 22 11 70 31
Fax 39066 0
Email 39066 0
[email protected]
Contact person for public queries
Name 39067 0
Mamadou Dit Dialaw
Address 39067 0
P.O. Box 169
Nouakchott
Mauritania
Country 39067 0
Mauritania
Phone 39067 0
+ 222 22 11 70 31
Fax 39067 0
Email 39067 0
[email protected]
Contact person for scientific queries
Name 39068 0
Mamadou Dit Dialaw
Address 39068 0
P.O. Box 169
Nouakchott
Mauritania
Country 39068 0
Mayotte
Phone 39068 0
+ 222 22 11 70 31
Fax 39068 0
Email 39068 0
[email protected]

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.