Efficacy and safety of Artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Zhob of Balochistan province and Khyber Agency of FATA, Pakista

Phase 4

Completed

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

• Registration Number: ACTRN12617001025325
• Lead Sponsor: Ministry of National Health Services Regulations and Coordination

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-14
• Last Update Posted: 11 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1.Age between 6 months and above with the exception of 12-17 years old female minors and unmarried females above 18 years and above;
2.Mono-infection with P. falciparum detected by microscopy;
3.Parasitaemia of 500 – 200000 per microL asexual forms;
4.Presence of axillary or tympanic temperature greater or equal to 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 18 years;
8.Informed assent from any minor participant aged from 12 to 17 years; and
9.Consent for pregnancy testing from married female aged 18 years and above.

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.Mixed or mono-infection with another Plasmodium species detected by microscopy;
4.Presence of severe malnutrition defined as a child aged 6-60 months who has a mid-upper arm circumference below 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 of married women aged 18 years and above; and
9.Unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.

Study & Design

• Study Type: Interventional
• Study Design: Not specified