Efficacy and safety of artemether-lumfantrine for the treatment of uncomplicated Plasmodium falciparum in Comores

Phase 4

Completed

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

• Registration Number: ACTRN12617001051336
• Lead Sponsor: Ministry of Health of Comoros

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-19
• Study Completion: 2018-01-08
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1.age between six months and 60 years, excluding females aged 12 and above years;
2.mono-infection with P. falciparum detected by microscopy;
3.parasitaemia of 500–200,000/microliter asexual forms;
4.presence of axillary temperature greater or equal to 37.5 degrees C 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 18 years.
8.informed assent from any minor participant aged from 12 to 18 years.

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.weight under 5 kg;
3.Hemoglobin less than 8 g/dl;
4.mixed or mono-infection with another Plasmodium species detected by microscopy;
5.presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference below 115 mm)
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);

Study & Design

• Study Type: Interventional
• Study Design: Not specified