Efficacy and safety of Artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in Eritrea

Phase 4

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12619000859189
• Lead Sponsor: Ministry of Health of Eritrea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-17
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

1.age between 6 months and above;
2.infection with P. falciparum or P. vivax a parasites confirmed by positive blood smear (no mixed infection);
3.parasitaemia of 250-200, 000 asexual forms per microliter;
4.presence of axillary or tympanic temperature greater or equal to 37.5 degree centigrade or history of fever during the past 24 h;
5.ability to swallow oral medication;
6.ability and willingness to comply with the study protocol for the duration of the study and to comply with the study follow-up visit schedule;
7.informed consent from the patient or from a parent or guardian in the case of children aged less than 18;
8.informed assent from any minor participant aged from 12 to 18 years; and
9.Consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active) and from their parent or guardian if under the age of 18.

Exclusion Criteria

1.presence of general danger signs in children aged under 12 years or signs of severe P. falciparum or P. vivax malaria according to the definitions of WHO;
2.weight under 5 kg;
3.haemoglobin < 8 g per deciliter;
4.presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score, or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm).
5.presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
6.regular medication, which may interfere with antimalarial pharmacokinetics;
7.history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
8.a positive pregnancy test or breastfeeding; and
9.unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age (defined as age above 12 years and sexually active).

Study & Design

• Study Type: Interventional
• Study Design: Not specified