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.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613000411741
• Date of registration: 15/04/2013
• Prospective Registration: Yes
• Primary sponsor: Ministry of Health of Mauritania
• 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.
• Date of first enrolment: 01/09/2013
• Target sample size: 180
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12613000411741.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Mauritania

Contacts

• Name: Dr Mamadou Dit Dialaw

• Name: Dr Mamadou Dit Dialaw

Key inclusion & exclusion criteria

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



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


Age minimum: 6 Months
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Plasmodium vivax malaria;
Plasmodium vivax malaria

Intervention(s)

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.

Primary Outcome(s)

Cure rate in terms of adequate clinical and parasitological response at day 28 as determined by clinical examination and blood microscopy[day 28]

Secondary Outcome(s)

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.[day 28]

Secondary ID(s)

Nil

Source(s) of Monetary Support

World Health Organisation

Ministry of Health of Mauritania

Ethics review

Status: Approved
Approval date:
Contact:

World Health Organisation Ethics Review Committee (WHO ERC)