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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613000396729
• Date of registration: 11/04/2013
• Prospective Registration: Yes
• Primary sponsor: Ministry of Health Mauritania
• 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
• Date of first enrolment: 01/09/2013
• Target sample size: 120
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12613000396729.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: 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.

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

Health Condition(s) or Problem(s) studied

Uncomplicated P falciparum malaria;
Uncomplicated P falciparum malaria

Infection - Other infectious diseases

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

Nil

Source(s) of Monetary Support

World Health Organisation

Ministry of Health Mauritania

Ethics review

Status: Approved
Approval date:
Contact:

World Health Organisation, Ethical Review Committee (WHO ERC)