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.

Not Applicable

• Conditions: Plasmodium vivax malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12613000411741
• Lead Sponsor: Ministry of Health of Mauritania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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]