Efficacy and safety of Artemether-Lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in different sentinel site in Suda

Phase 4

Completed

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

• Registration Number: ACTRN12622000930785
• Lead Sponsor: Ministry of Health

Brief Summary

Out of the 264 targeted sample, 212 (86, 83 and 43 at Blue Nile, Kassala and Sennar, respectively) patients of which 193 (72 at Blue Nile, 82 at Kassala and 39 at Sennar) reached the study endpoints during the 28-day follow-up. Per-protocol analysis showedPCR corrected artemether-lumefantrine cure rates of 95.8% in Blue Nile, 96.3% in Kassala and 89.7% in Sennar. No K13 mutations markers for K13 mutations, amplification of plaspepsin 2 and madr-1 genes were not observed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-03-25
• Study Start: 2022-06-29
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

1.Age above six months excluding unmarried females of child bearing age (from 12 years).
2.mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
3.parasitaemia of 1000–100000 asexual parasite per microliter forms;
4.presence of axillary temperature equal or greater than 37.5 degrees 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 visit schedule;
7.informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority;
8.informed assent from any minor participant aged from 12 to 17 years; and
9.consent for pregnancy testing from married female of child-bearing age

Exclusion Criteria

1. presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO;
2. unmarried female in the child bearing age
3. weight under 5 kg;
4. mixed or mono-infection with another Plasmodium species detected by microscopy;
5. presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score
6. 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);
7. regular medication, which may interfere with antimalarial pharmacokinetics;
8. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
9. a positive pregnancy test.
10. 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