Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in At Tur Bani Qa'is, Harad, Almusaymir, Jabal Ash Sharq, Al Udayn and Bajil districts in Yemen

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12610000696099
• Date of registration: 24/08/2010
• Prospective Registration: No
• Primary sponsor: Ministry of Public Health and Population
• Public title: Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in At Tur Bani Qa'is, Harad, Almusaymir, Jabal Ash Sharq, Al Udayn and Bajil districts in Yemen
• Scientific title: Efficacy and safety of artesunate+sulfadoxine/pyrimethamine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Yemen
• Date of first enrolment: 08/11/2009
• Target sample size: 522
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12610000696099.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Yemen

Contacts

• Name: Dr Dr Mohamed Abdullah Al-Henemi

• Name: Dr Dr Fathi Ali Mohammed Hizam

Key inclusion & exclusion criteria

Inclusion criteria: 1. age 6 months and above;
2. mono-infection with Plasmodium falciparum (P.falciparum) detected by microscopy;
3. parasitaemia of 500-200000/microliter asexual forms;
4. presence of axillary temperature less than or equal to 37.5 degrees centigrade;
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; and
7. informed consent from the patient or from a parent or guardian in the case of children.
Exclusion criteria: 1. 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).
2. mixed or mono-infection with another Plasmodium species detected by microscopy;
3. 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 <110 mm);
4. 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 immunodeficiency virus/Acquired immune deficiency syndrome or acquired immunodeficiency syndrome (HIV/AIDS);
5. regular medication, which may interfere with antimalarial pharmacokinetics;
6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
7. unmarried women of child-bearing age;
8. a positive pregnancy test or breastfeeding;
9. unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age.

Age minimum: 6 Months
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Epidemiology

Infection - Studies of infection and infectious agents

malaria;
malaria

Intervention(s)

One-arm propective evaluation with:
(a) artesunate+sulfadoxine/pyrimethamine combination therapy in 4 sites (Al Tor beni Qais, Harad, Almosaimeer, Al Odein) and
(b) artemether-lumefantrine combination therapy in two sites (Jabal Al Sharq and Bajil).

Dose regimen:
(a) artesunate+sulfadoxine/pyrimethamine tablets: artesunate 4 mg/kg body weight (bw) per day for 3 days plus a single dose of 25/1.25 mg/kg bw of sulfadoxine/ pyrimethamine.

(b) artemether-lumefantrine tablets (tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrine twice a day for 3 days according to the following weigth bands:
5-14 kg bw: 1 tablet; 15-24 kg bw: 2 tablets; 25-34 kg bw: 3 tablets and =35 kg bw: 4 tablets.

All treatment will be orally taken tablets

Primary Outcome(s)

% of artesunate+sulfadoxine/pyrimethamine treatment failure (early treatment failure+late clinical failure+late parasitological failure)

Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatmnt outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).[At 28 day following treatment]

% of artemether-lumefantrine treatment failure (early treatment failure+late clinical failure+late parasitological failure).
Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatmnt outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).[At 28 day following treatment]

% of adverse events in the artesunate+sulfadoxine/ pyrimethamine and artemether-lumefantrine treated groups.


All patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. All adverse events will be recorded on the case report form.[At 28 day following treatment]

Secondary Outcome(s)

Nil[Nil]

Secondary ID(s)

None

Source(s) of Monetary Support

Ministry of Public Health and population

Ethics review

Status: Approved
Approval date:
Contact:

General Doctorate for Research and Studies

Status: Approved
Approval date:
Contact:

WHO Ethical Review Committee (ERC)