Efficacy and safety of artesunate + amodiaquine for the treatment of uncomplicated Plasmodium falciparum infection in the new epidemiological context of low malaria transmission in Zanzibar

Phase 4

Withdrawn

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12611000426987
• Lead Sponsor: Ministry of Health and Social Welfare, Zanzibar, Tanzania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

*age equal to or more than 3 months;
*mono-infection with P. falciparum detected by microscopy.
*presence of P. falciparum malaria asexual parasitaemia (any level);
*presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 h;
*ability to swallow oral medication;
*ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
*informed consent from the patient or from a parent or guardian in the case of children.

Exclusion Criteria

*presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of World Health Organization (WHO);
*mixed or mono-infection with another Plasmodium species detected by microscopy;
*presence of severe malnutrition (defined as a child whose growth standard is below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm);
*presence of febrile conditions 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 diseases (e.g. cardiac, renal and hepatic diseases, Human Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(HIV/AIDS);
*regular medication, which may interfere with antimalarial pharmacokinetics;
*history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
* a positive pregnancy test
* unable to or unwilling to take contraceptives

Study & Design

• Study Type: Interventional
• Study Design: Not specified