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

Not Applicable

• Conditions: ncomplicated P falciparum malaria; Uncomplicated P falciparum malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12613000396729
• Lead Sponsor: Ministry of Health Mauritania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

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

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rate at day 28 after adjustment by polymerase chain reaction (PCR) to differentiate between recrudescence and new infection. [day 28]

Secondary Outcome Measures

Name	Time	Method
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.[day 28]